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
January 2, 2020
Date of Report
(Date of earliest event reported)
DURECT CORPORATION
(Exact name of Registrant as specified in its charter)
Delaware |
|
000-31615 |
|
94-3297098 |
(State or other jurisdiction of incorporation or organization) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
10260 Bubb Road
Cupertino, CA 95014
(Address of principal executive offices) (Zip code)
(408) 777-1417
(Registrant’s telephone number, including area code)
(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:
☐ |
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 |
Name of Each Exchange on Which Registered |
|
Common Stock $0.0001 par value per share Preferred Share Purchase Rights |
DRRX |
The NASDAQ Stock Market LLC (The Nasdaq Capital Market) |
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. ☐
2
On January 2, 2020, DURECT Corporation issued a press release announcing the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm daily for 28 days. DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator’s Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses. Daily topical application of DUR-928 was well tolerated with no meaningful differences in adverse events between the treatment and vehicle (placebo) groups. There were no AEs attributed to the study drug. A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
3
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.
|
|
DURECT Corporation |
||
|
|
|
|
|
Date: January 2, 2020 |
|
By: |
|
/s/ Michael H. Arenberg |
|
|
|
|
Michael H. Arenberg Chief Financial Officer
|
|
|
|
|
|
4
Exhibit 99.1
DURECT Corporation Announces Top-Line Results from Phase 2a Clinical Trial in Patients with Psoriasis
CUPERTINO, Calif., January 2, 2020 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm daily for 28 days.
DUR-928 did not demonstrate a benefit over vehicle (placebo) based on Investigator’s Global Assessment (IGA), which was the scoring system for the primary analysis, or in any of the secondary analyses. Daily topical application of DUR-928 was well tolerated with no meaningful differences in adverse events between the treatment and vehicle (placebo) groups. There were no AEs attributed to the study drug.
“Based on the top-line data, we do not plan to continue development of topical DUR-928 in psoriasis,” said James E. Brown, President and CEO of DURECT. “With the recently announced positive results from our Phase 2a alcoholic hepatitis trial, our focus moving forward with DUR-928, will be on completing the NASH trial in the first half of this year and initiating the Phase 2b AH trial in the middle of the year.”
About the DUR-928 Psoriasis Phase 2a Trial
The trial was a Phase 2a, randomized, double-blind, vehicle-controlled, multi-center, proof-of-concept study in which DUR-928 was applied topically once-daily for 28 days with a 28-day follow-up period in patients with mild to moderate plaque psoriasis. The trial was conducted in the U.S. Each patient served as their own control, applying DUR-928 to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm. After the treatment period, patients were followed for an additional four weeks.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as AH and acute kidney injury (AKI) and chronic hepatic diseases such as NASH. DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. Key product candidates in this category include POSIMIR® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, and a long-acting injectable SABER-based HIV investigational product being developed with Gilead. For more information about DURECT, please visit www.durect.com.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential benefits and uses of DUR-928 to treat AH and about other potential uses of DUR-928 to treat NASH, AKI and other diseases, the potential use of POSIMIR to treat post-operative pain, and the potential development of a long-acting injectable SABER-based HIV product with Gilead are forward-looking statements involving risks and uncertainties that can
cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risk of delays in clinical trials or adverse safety events from patients administered with DUR-928, the risk that the ongoing clinical trial of DUR-928 in NASH does not successfully achieve its endpoints, the risk that placebo controlled studies of DUR-928 required for regulatory approval will not replicate results from open label clinical trials or trials with small numbers of patients or historical controls, the risks that the long-acting injectable SABER-based HIV investigational product being developed with Gilead will not succeed or that Gilead will abandon this program, the risk that the FDA Advisory Committee will not recommend approval of POSIMIR or that the FDA will not approve POSIMIR, and the risk of delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of any of our product candidates. Further information regarding these and other risks related to DURECT is included in DURECT's Form 10-Q filed on November 5, 2019 under the heading “Risk Factors” and in subsequent reports that we file with the Securities and Exchange Commission.
NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. DUR-928 and POSIMIR are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
Corporate Contact
Mike Arenberg
DURECT
Chief Financial Officer
+1-408-346-1052
mike.arenberg@durect.com
Media Contact
Alison Chen
LifeSci Public Relations
+1-646-876-4932
achen@lifescipublicrelations.com