UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 23, 2019

 

OVID THERAPEUTICS INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38085

46-5270895

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

1460 Broadway, Suite 15044

New York, New York

 

10036

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 646-661-7661

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock par value $0.001 per share

 

OVID

 

The Nasdaq Stock Market LLC

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

 

 


Item 7.01.Regulation FD Disclosure.

 

On September 23, 2019, Ovid Therapeutics Inc. (the “Company”) posted its ENDYMION Update presentation, dated September 23, 2019, to the “Events & Presentations” subsection of the “Investors & Media” tab on the Company’s website at www.ovidrx.com. A copy of the presentation is attached hereto as Exhibit 99.1 and is incorporated by reference into this Item 7.01.

This information, including the Exhibit 99.1 referenced herein, is “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, only if and to the extent such subsequent filing specifically references the information herein as being incorporated by reference in such filing.

 

Item 8.01.Other Events.

 

On September 23, 2019, the Company issued a Press Release announcing Positive Initial Data from Ongoing ENDYMION Open-Label Extension Trial of Soticlestat in People with Rare Epilepsies.

 

A copy of the press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01.Financial Statements and Exhibits

(d) Exhibit

 

Exhibit No.

  

Description

 

 

99.1

99.2

  

ENDYMION Update presentation, dated September 23, 2019

Press Release, dated September 23, 2019

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

OVID THERAPEUTICS INC.

 

 

By:    

/s/ Thomas M. Perone

 

Thomas M. Perone

 

General Counsel & Corporate Secretary  

Dated: September 23, 2019

 

 

SLIDE 0

Soticlestat (OV935) ENDYMION Update September 23, 2019 Exhibit 99.1

SLIDE 1

Disclaimers and Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Forward-looking statements contained in this presentation include statements about the progress, timing, clinical development and scope of clinical trials and the anticipated reporting schedule of clinical data for the Company’s product candidates; the potential therapeutic benefit of the Company’s product candidates; the timing and outcome of discussions with regulatory authorities; the success of any partnering opportunities; and the use of 24HC as a biomarker for target engagement. Each of these forward-looking statements involves risks and uncertainties. These statements are based on the Company’s current expectations and projections made by management and are not guarantees of future performance. Therefore, actual events, outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. Factors that may cause actual results to differ materially from these forward-looking statements. Initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as otherwise required under federal securities laws, we do not have any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.

SLIDE 2

Initial Positive Data from Ongoing ENDYMION Open-Label Extension Trial Continue to Support Development of Soticlestat in Rare Epilepsies While a small number of patients, open-label ENDYMION data reinforce the seizure reduction demonstrated in our previous 12-week Phase 1b/2a adult DEE (developmental and epileptic encephalopathies) trial Longer-term data out to 48 weeks suggest increased seizure reduction with prolonged treatment of soticlestat, with median seizure frequency reductions of 84% following 25-36 weeks (n=6) and 90% following 37-48 weeks (n=4 reaching this timepoint) of treatment Soticlestat continues to show a favorable safety and tolerability profile This is a highly-refractory, difficult-to-treat, heterogeneous patient population Continue to anticipate initial data from ARCADE study (Dup15q and CDKL5) in 1Q 2020; topline results from randomized, double-blind ELEKTRA study (LGS and Dravet) now expected in 2H 2020 as a result of robust enrollment

SLIDE 3

Soticlestat is Being Evaluated in a Robust and Comprehensive Clinical Development Program in DEE Chromosome 15q Duplication Syndrome CDKL5 Deficiency  Disorder Lennox-Gastaut syndrome Dravet syndrome ARCADE: Phase 2 Open-label pilot trial ~30 patients ELEKTRA: Phase 2 Double-blind, placebo-controlled trial 126 pediatric patients Phase 1b/2a Adult patients Primary endpoint: Percent change seizure frequency DEE Primary endpoint: Percent change seizure frequency Primary endpoint: Safety and tolerability Completed ENDYMION Open-label extension (OLE) trial Within our partnership, Takeda is also conducting an ongoing P2 randomized trial in Complex Regional Pain Syndrome with soticlestat

SLIDE 4

Epileptogenic insult ↑ Modulation of NMDA Receptor ↑ Modulation of Glial Function Epilepsy ↑ 24HC Cholesterol ↑ Glutamate Release ↑ Inflammation ↑ Tissue Excitability CH24H Mechanism of soticlestat1,2 Soticlestat is a Highly Selective, First-in-Class CH24H Inhibitor in Development to Reduce Excessive Glutamatergic Signaling and Help Improve Seizure Control Thus, soticlestat has the potential to reduce seizure susceptibility and improve seizure control1 Reducing 24HC levels mediates reduced glutamatergic (NMDA) signaling, modulation of glial (ie, astrocyte and microglia) function and activation, and reduced inflammation1 Soticlestat inhibits CH24H resulting in a dose-dependent reduction in plasma 24HC levels1 Soticlestat may provide benefit through mechanisms that are not targets of conventional AEDs1,2 1. Salamone A et al. Poster presented at: ECE 2018. 2. Nishi T et al. Poster presented at: AAN 2018. Soticlestat T

SLIDE 5

DEE Encompass Diverse Etiologies with Few or No Approved Treatments CDKL5 Deficiency Disorder (CDD) Chromosome 15q Duplication Syndrome (Dup15q) Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS) Etiology Mutations in CDKL5 gene on X chromosome Duplication in chromosome 15q11.2-q13.1 region 80% have mutations in Scn1a gene Multiple Age of onset Birth–3 months 6 months–9 years Birth–1 year 2–5 years Prevalence ~1:40,000–1:60,000 (5.5K- 8.1K Patients in the US) ~1:30,000 (11K Patients in the US) ~1:15,000–1:21,000 (15.5K to 22K patients in the US) ~1:11,000 (30K Patients in the US) Clinical Manifestations Long, intractable seizures, periods of repeated seizures Mainly affects females Atypical hypsarrhythmia pattern on EEG over time Repetitive hand movements Hypotonia Hypotonia, motor delays, ASD symptoms, anxiety disorder Infantile spasms progressing to LGS-type syndrome Prolonged focal that can evolve to generalized convulsive tonic-clonic seizures First seizure associated with fever in 60% of cases Developmental delay Drop seizures Multiple seizure types More common in males Intellectual disabilities along with psychiatric comorbidities Distinctive EEG brain wave pattern FDA-approved Therapies None None Epidiolex® (cannabidiol), stiripentol Lamotrigine, topiramate, felbamate, rufinamide, clobazam, clonazepam, Epidiolex® (cannabidiol) Soticlestat has the potential to treat ~70K patients in the U.S. that are affected by these conditions

SLIDE 6

Previous Phase 1b/2a Adult DEE Trial Results Soticlestat Was Well Tolerated with Reduced Seizure Frequency Over Time Soticlestat achieved primary endpoint of safety and tolerability as measured by incidence of adverse events (AEs)* The majority of AEs were mild Seizure Frequency 61% reduction in median seizure frequency observed at scheduled Day 92 Two of 11 patients became seizure-free (last 28 days of treatment to Day 92) Median Reduction from Baseline in Total Seizures** per 28 Days (FSA, Part 2, excluding patients on perampanel)a *AEs that occurred more frequently in the soticlestat-treatment group vs placebo group were dysarthria, insomnia, lethargy, seizure cluster, and upper respiratory infection. **Data represent per protocol analyses; ITT group (n=18) demonstrated median reduction in total seizures of 36% at Day 85. Two patients withdrew in Part 1 (weakness (n=1); difficulty with walking/worsening lethargy (n=1)) and two patients withdrew in Part 2 (seizure cluster (n=2)). a Based on an interval averaged over 28 days, excluding myoclonic seizures. The first dose day is Study Day 1. Safety And Tolerability Patient Diagnosis at Trial Entry LGS (n=6), Dravet (n=1), DEE (n=6), Tuberous sclerosis (n=1), All other (n=4)

SLIDE 7

Previous Phase 1b/2a Adult DEE Trial: Key Takeaways and Learnings Safety Soticlestat showed a favorable safety profile and was generally well tolerated Efficacy Soticlestat progressively reduced seizure frequency over time Two of 11 patients became seizure-free (to Day 92) Soticlestat appears to be effective across multiple seizure types/DEEs Actions taken in DEE clinical program since adult data readout Open label extension trial ENDYMION initiated to assess long-term safety and effectiveness Extended the duration of treatment in ongoing trials (ARCADE and ELEKTRA) Excluded concomitant perampanel due to potential interaction

SLIDE 8

ENDYMION DESIGN An OLE Study to Evaluate Long-Term Safety and Efficacy of Soticlestat Trial Design Prospective, interventional, open-label, multi-site, extension trial Endpoints Aged ≥2 and ≤65 years Has participated in a previous soticlestat trial Soticlestat Treatment (104 weeks) (Up to 2 weeks titration followed by ~102 weeks maintenance)* Completion of Previous Soticlestat Study *Patients who roll over from an open-label trial will continue on their current dose for 104 weeks without titration. Key Inclusion Criteria Primary: Safety and tolerability Secondary: % change in median seizure frequency

SLIDE 9

Today’s Data Cut from ENDYMION Consists of Patients Who Completed the 12-Week Phase 1b/2a Adult DEE Trial Patients who completed Adult DEE trial All patients experienced an interruption in treatment with soticlestat from end of adult trial to start of ENDYMION ranging 6 weeks – 52 weeks, due to timing of ENDYMION study start Some patients (7) did not roll over 1 Loss-to-follow up, 6 did not choose to (logistical, not interested, prolonged lag period) 6 patients from adult DEE trial included in data analyses reported today Excludes 1 patient on concomitant perampanel during trial who discontinued Patients from ARCADE (open label trial; CDKL5 Deficiency Disorder and Dup15q Syndrome) All patients to date have rolled over immediately without gap to ENDYMION Data are not included in today’s analysis due to patients’ limited treatment duration in the ENDYMION study Initial ARCADE data expected in 1Q 2020 Patients from ELEKTRA – (double blind, randomized trial; LGS and Dravet syndrome) All patients to date have rolled over immediately without gap to ENDYMION Data are not included in today’s analysis in order to protect integrity of the double-blind trial ELEKTRA data now expected 2H 2020 due to robust enrollment

SLIDE 10

Most patients were on multiple anti-epileptic medications Most common AED (taken by at least 2 patients) were lamotrigine, oxcarbazepine, rufinamide, topiramate, valproate. ENDYMION Patient Baseline Demographics Patient population was not enriched for any specific condition Patients were each diagnosed with one of multiple DEEs Withdrawal * (n=1) Did not opt in (n=7) Eligible patients (n=14) Phase 1b/2a adult DEE trial Enrolled (n=7) ENDYMION Analysis (n=6) * One LGS patient was treated with perampanel and withdrew for unrelated medical reasons and is excluded from analysis   Adult DEE trial subjects (n=6) Age (years)     n   6 Mean (SD)   27.0 (7.29) Median   26 Min, Max   19, 40       Sex, n (%)     Male   5 (83.3) Female   1 (16.7)       Ethnicity, n (%)     Not Hispanic of Latino   6 (100.0)       Race, n (%)     White   5 (83.3) African American   1 (16.7) Diagnoses Concomitant Medications

SLIDE 11

ENDYMION Safety and Tolerability Majority of AEs Were Mild and Consistent with Phase 1b/2a Adult DEE Study Most common TEAEs, any group; number (%) Patients (n=6) Abdominal pain, upper 1 (16.7) Nausea 1 (16.7) Pyrexia 1 (16.7) Bronchial wall thickening 1 (16.7) Rales 1 (16.7) Number of AEs (%) Patients (n=6) TEAEs 3 (50.0) Mild TEAE 2 (33.3) Moderate 1 (16.7) Severe TEAE 0 (0) AE-related withdrawal 0 (0) SAEs 0 (0) Deaths 0 (0) One related AE: nausea No discontinuations due to AE AE=adverse event; SAE=serious adverse event; TEAE=treatment-emergent adverse event.

SLIDE 12

ENDYMION Efficacy Median Seizure Frequency Reduction Increased Over Time Chart shows data from the 6 patients in adult DEE trial who continued in ENDYMION Break between end of Adult DEE trial and ENDYMION (range 6-52 weeks) Baseline seizure frequency of median 11.5 seizures per 28 days in ENDYMION Longest seizure free interval 264 days (out of total treatment duration 350 days) in ENDYMION -48% -90% -84% -65% -59% Last 28 days in adult DEE Study Median % change in seizure frequency including the patient with concomitant perampanel (N=7) per 12 weeks: -31%, -46%, -82%, -90% *two patients have not yet completed 48 weeks of dosing

SLIDE 13

Individual Patients’ Seizure Frequency in Adult (last 28 days) and ENDYMION Studies Denotes seizure frequency reduction at last 28-day period of adult DEE study Baseline=2 Baseline=71 Baseline=4 Baseline=3 Baseline=20 Baseline=19

SLIDE 14

ENDYMION Summary of Findings and Interpretations Safety Soticlestat continues to show a favorable safety and tolerability profile No new safety signals were identified with longer term exposure Majority of AEs are mild; no serious adverse events (SAEs) reported Consistent with prior observations in 12-week Phase 1b/2a adult DEE trial Efficacy  Consistent with prior observations in 12-week Phase 1b/2a adult DEE trial Data suggest increasing activity with longer duration of soticlestat treatment Reduction of seizure activity appears to occur progressively Some patients experience prolonged intervals of seizure freedom Encouraging data despite small number of patients

SLIDE 15

Soticlestat: Next Steps ARCADE Five patients have rolled over into ENDYMION ARCADE trial initial data anticipated for Q1 2020 If positive, will engage global regulatory authorities to discuss registration path ELEKTRA Interest in trial has been strong and 9 patients have rolled over into ENDYMION Enrollment ahead of initial expectations ELEKTRA trial topline results now anticipated for 2H 2020

SLIDE 16

Ovid: Building a Leading Company in Neurology PRODUCT CANDIDATE RESEARCH PRECLINICAL PHASE 1 PHASE 2 PHASE 3 INDICATION Angelman Syndrome Fragile X NEPTUNE – Ongoing ELARA OLE – Ongoing ROCKET – Ongoing CDKL5 Deficiency Disorder / Dup15q Syndrome Dravet / LGS ARCADE – Ongoing ENDYMION OLE – Ongoing ELEKTRA – Ongoing ENDYMION OLE – Ongoing Treatment Resistant Epilepsy Angelman Syndrome OV101 δ-selective GABAA receptor agonist OV935 CH24H inhibitor OV329 GABA aminotransferase inhibitor OV881 microRNA KEY MILESTONES NEPTUNE Data: Mid-2020 ROCKET Data: YE19/Early 2020 ELEKTRA Data: 2H 20 ARCADE Data: 1Q 20

SLIDE 17

Ovid Therapeutics would like to thank the patients, families, caregivers, clinicians, and trial staff for their support and active involvement in the soticlestat clinical development program 

Exhibit 99.2

 

Ovid Therapeutics Announces Positive Initial Data from Ongoing ENDYMION Open-Label Extension Trial of Soticlestat in People with Rare Epilepsies

 

Sustained and Progressively-Improving Median Seizure Frequency Reduction Reaching 84-90% with Prolonged Treatment of Soticlestat in this Difficult-to-Treat Patient Population

 

Soticlestat Continues to Advance in Rare Epilepsies; Initial Data from Phase 2 ARCADE Trial Anticipated in Q1 2020 and Data from ELEKTRA Trial Now Anticipated in 2H 2020 Due to Robust Enrollment

 

Ovid to Host Conference Call Today at 8:00 a.m. EDT

 

NEW YORK, September 23, 2019 – Ovid Therapeutics Inc. (NASDAQ: OVID) today announced positive initial data from the ENDYMION trial, a Phase 2 open-label extension study of soticlestat (OV935/TAK935) in patients with rare developmental and epileptic encephalopathies (DEE). DEE is a heterogeneous group of rare highly-refractory epilepsy syndromes and encompasses Dravet syndrome, Lennox-Gastaut syndrome (LGS), and others. Soticlestat is a potent, highly-selective first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being investigated as a novel approach to treating adults and children with rare epilepsies in collaboration with Takeda Pharmaceutical Company Limited.

 

This initial data from the ENDYMION open-label extension trial is from patients who previously completed Ovid’s 12-week Phase 1b/2a clinical trial of soticlestat in adults with DEE. At 12 weeks, safety and tolerability observations with soticlestat in the ENDYMION study were consistent with the completed Phase 1b/2a clinical trial. Furthermore, longer-term data from ENDYMION out to 48 weeks suggest increased seizure reduction with prolonged treatment of soticlestat in this difficult-to-treat, adult patient population with various types of DEE. Median seizure frequency reductions were 84% following 25-36 weeks (n=6) and 90% following 37-48 weeks (n=4) of treatment. In addition, the longest seizure-free durations experienced by two different patients were 264 consecutive days and 150 consecutive days, respectively.

 

“While this first data cut includes a small number of patients, these initial results from ENDYMION reaffirm the potential of soticlestat to provide a tangible and durable clinical benefit for patients with DEE, a group of difficult-to-treat seizure disorders with limited therapeutic options,” said Amit Rakhit, MD, MBA, Chief Medical Officer and Head of Research & Development at Ovid. “Specifically, we believe the sustained and progressively-improving median seizure reduction up to 90% seen in these patients is encouraging and, while early, compares favorably to other studies in different types of DEE. We look forward to additional progress in our broad DEE clinical development program including initial data from


 

the ARCADE study expected in Q1 2020 and topline results from the randomized ELEKTRA study now expected in 2H 2020 as a result of robust enrollment.”

 

ENDYMION Study Design

ENDYMION is a prospective, multi-center, open-label extension study of soticlestat in patients with DEE who have participated in a previous soticlestat clinical study. The primary objective of ENDYMION is to assess the long-term safety and tolerability of soticlestat over two years of treatment in patients with rare epilepsies and secondarily, to evaluate the effect of soticlestat on seizure frequency over time.

 

Upon completion of a previous soticlestat clinical study, patients have the option to enroll in the open-label ENDYMION study with titration up to maintenance dose. Target dosing is 600mg per day (300mg twice a day) for adults and weight-based dosing for pediatric patients. Based on the insights gained from the previous 12-week Phase 1b/2a clinical trial of soticlestat in adults with DEE and, as previously announced, Ovid amended the ENDYMION study protocol to prohibit perampanel as a concomitant medication due to a potential interaction.

 

Patient Baseline Demographics

ENDYMION initially enrolled 7 patients who previously completed the 12-week Phase 1b/2a clinical trial of soticlestat in adults with DEE. Patients entering the trial experienced multiple seizure types, including motor seizures. Patients were on a number of anti-epileptic medications. The patient population was highly-heterogeneous and was not enriched for any specific condition and patients were each diagnosed with one of multiple DEEs. One patient enrolled into ENDYMION prior to the completion of the Phase 1b/2a clinical trial and was on concomitant perampanel. This patient was withdrawn from ENDYMION and data is not reported for this patient. Thus, the primary analysis reported today consists of 6 patients.

 

These 6 patients were re-baselined for seizure frequency due to a lag period ranging from 6 to 52 weeks between their completion of the Phase 1b/2a adult DEE study and the initiation of the ENDYMION study.

 

Seizure Frequency Reduction Results

Overall, findings suggest that prolonged treatment with soticlestat leads to increased seizure frequency reduction and is consistent with the believed mechanism of action of soticlestat.

 

Table 1: % Reduction from Baseline in Seizure Frequency

 

Weeks 1-12

(n=6)

Weeks 13-24

(n=6)

Weeks 25-36

(n=6)

Weeks 37-48

(n=4)*

Overall median % reduction in seizure frequency from baseline

48%

65%

84%

90%

% of Patients with ≥50% reduction in seizure frequency from baseline

50%

50%

67%

75%

*two patients have not yet completed 48 weeks of dosing

 

Patient baseline seizure frequency ranged from 2 to 71 (median=11.5). In general, a greater reduction in seizure frequency was observed in those with higher baseline seizure frequency. In terms of overall

 

 


 

seizure free interval during treatment, one patient experienced 264 consecutive days and one patient experienced 150 consecutive days without a seizure.

 

In addition to the 6 patients from the Phase 1b/2a adult DEE study included in this data analysis, all patients who have completed the ARCADE and ELEKTRA studies to date have rolled over into ENDYMION. Data from patients who have completed the ARCADE study are not included in today’s analysis due to their limited treatment duration in the ENDYMION study. Data from patients previously treated in the ELEKTRA study are not included in today’s analysis due to the ongoing study being double-blinded and placebo-controlled. Ovid looks forward to reporting initial data from the ARCADE trial in Q1 2020 as previously guided. As a result of robust enrollment, Ovid now expects to report topline results from the ELEKTRA trial in 2H 2020.

 

Safety

Overall, safety findings are consistent with prior observations in the 12-week Phase 1b/2a adult DEE study. Soticlestat continues to show a favorable safety and tolerability profile. The majority of adverse events (AEs) were mild and comparable with those from the Phase 1b/2a adult DEE study. Specifically, AE’s that occurred included upper abdominal pain, pyrexia, bronchial wall thickening, and rales. There was one treatment-related AE of nausea. No serious adverse events (SAEs) were observed.

 

About the Ongoing ARCADE and ELEKTRA Trials

Beyond the ENDYMION open-label extension study, Ovid and Takeda are also conducting the Phase 2 ARCADE and ELEKTRA trials in pediatric DEE patient populations. Upon the completion of the ARCADE and ELEKTRA trials, patients are eligible to enroll in the ENDYMION open-label extension study.

 

ARCADE is a Phase 2, multi-center, open-label, pilot study that will evaluate the treatment of soticlestat in approximately 30 patients, aged 2 to 35 years old, with refractory epileptic seizures associated with CDKL5 Deficiency Disorder (CDD) or Dup15q syndrome. This study consists of a four to six-week screening period to establish baseline seizure frequency followed by a 20-week treatment period. The primary endpoint is the change in motor seizure frequency in patients treated with soticlestat by disorder. Initial data is expected in Q1 2020.  

 

ELEKTRA is an international Phase 2, multi-center, randomized, double-blind, placebo-controlled study that will evaluate the treatment of soticlestat in approximately 126 pediatric patients, aged 2 to 17 years, with epileptic seizures associated with Dravet syndrome or Lennox-Gastaut syndrome (LGS). The study consists of a four to six-week screening period to establish baseline seizure frequency followed by a 20-week treatment period. The primary endpoint is the change from baseline in seizure frequency in patients treated with soticlestat compared to placebo by disorder. Topline results are expected in 2H 2020.

 

About Developmental and Epileptic Encephalopathies (DEE)
The International League Against Epilepsy (ILAE) defines an epileptic encephalopathy as a condition in which "the epileptiform EEG abnormalities themselves are believed to contribute to a progressive disturbance in cerebral function." These epilepsies cause significant morbidities for patients beyond what might be expected from the known underlying pathology alone and can worsen over time.

 

 


 

Developmental and epileptic encephalopathies typically present early in life and are often associated with severe cognitive and developmental impairment in addition to frequent treatment-resistant seizures throughout the person's lifetime. These disorders vary in age of onset, developmental outcomes, etiologies, neuropsychological deficits, electroencephalographic (EEG) patterns, seizure types, and prognosis.  

 

Despite the availability of medicines for epilepsy, there are few approved therapies for DEE and for several types there are no approved therapies. Novel therapies are needed as current therapies fail to alter the course of the disease or address co-morbidities, and many patients suffer from resistant seizures despite treatment with multiple anti-epileptic drugs (AEDs).

 

About Soticlestat
Soticlestat (OV935/TAK-935) is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H), with the potential to reduce seizure susceptibility and improve seizure control. CH24H is predominantly expressed in the brain, where it converts cholesterol into 24S-hydroxycholesterol (24HC) to adjust the homeostatic balance of brain cholesterol. 24HC is a positive allosteric modulator of the NMDA receptor and potentiates glutamatergic signaling associated with epilepsy. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of seizure activity. Recent literature indicates that CH24H is involved in over-activation of the glutamatergic pathway through modulation of the NMDA channel and that increased expression of CH24H can disrupt the reuptake of glutamate by astrocytes, resulting in epileptogenesis and neurotoxicity. Inhibition of CH24H by soticlestat reduces the neuronal levels of 24HC and may improve excitatory/inhibitory balance of NMDA channel activity.

To Ovid’s knowledge, soticlestat is the only molecule with this mechanism of action in clinical development as an AED. The United States Food and Drug Administration (FDA) has granted orphan drug designation to soticlestat for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome (LGS). Soticlestat is an investigational drug, not approved for commercial use.

 

About the Ovid/Takeda Collaboration
Ovid and Takeda entered into a global development and commercialization collaboration in January 2017 to evaluate soticlestat across a range of rare epilepsy syndromes. Under the terms of the agreement, the companies share in the development and commercialization costs on a 50/50 basis and, if successful, the companies will share in the profits on a 50/50 basis. Takeda will lead commercialization in Japan and has the option to lead in Asia and other selected geographies. Ovid leads clinical development activities and will lead commercialization in the United States, Europe, Canada and Israel.

 

Conference Call Information

Ovid Therapeutics will host a live conference call and webcast today at 8:00 a.m. Eastern Time. The live webcast can be accessed by visiting the Investors section of the company’s website at investors.ovidrx.com. Alternatively, please call 866-830-1640 (U.S.) or 210-874-7820 (international) to listen to the live conference call. The conference ID number for the live call is 5709139. A replay of the webcast will be available on the company’s website for two weeks following the live conference call.

 

About Ovid Therapeutics

 

 


 

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company’s most advanced investigational medicine, OV101 (gaboxadol), is currently in clinical development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935 (soticlestat) in collaboration with Takeda Pharmaceutical Company Limited for the potential treatment of rare developmental and epileptic encephalopathies (DEE).

 

For more information on Ovid, please visit http://www.ovidrx.com/.

 

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding advancing Ovid’s product candidates, progress, timing, scope and the potential therapeutic benefits based on results of clinical trials for Ovid’s product candidates; and the anticipated reporting schedule of clinical data regarding Ovid’s product candidates. You can identify forward-looking statements because they contain words such as “will,” “believes” and “expects.” Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include the fact that initial data from clinical trials may not be indicative, and are not guarantees, of the final results of the clinical trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and/or more patient data become available.  Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth in Ovid’s filings with the Securities and Exchange Commission under the caption “Risk Factors”. Ovid assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

 

Contacts

 

Investors and Media:

Ovid Therapeutics Inc.

Investor Relations & Public Relations

irpr@ovidrx.com

 

Or

 

Investors:

Steve Klass

Burns McClellan, Inc.

sklass@burnsmc.com

(212) 213-0006

 

 


 

 

Media:
Katie Engleman
1AB
katie@1abmedia.com
(919) 333-7722