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
October 21, 2019
Date of Report
(Date of earliest event reported)
DURECT CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware |
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000-31615 |
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94-3297098 |
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(State or other jurisdiction of incorporation or organization) |
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(Commission File Number) |
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(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of Each Class |
Trading Symbol |
Name of Each Exchange on Which Registered |
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Common Stock $0.0001 par value per share Preferred Share Purchase Rights |
DRRX |
The NASDAQ Stock Market LLC (The Nasdaq Capital Market) |
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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. ☐
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On October 21, 2019, DURECT Corporation issued a press release announcing that the results from the recently completed Phase 2a study of DUR-928 in patients with alcoholic hepatitis (AH) have been selected for an oral presentation as part of the late-breaking session of The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place on November 8-12, 2019, in Boston. Additionally, the study results were selected for inclusion in the ‘Best of The Liver Meeting’ summary slide presentation in the alcohol-related liver disease category. 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
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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.
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DURECT Corporation |
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Date: October 21, 2019 |
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By: |
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/s/ James E. Brown |
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James E. Brown President and Chief Executive Officer
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Exhibit 99.1
DURECT Announces DUR-928 Phase 2a Alcoholic Hepatitis Study Results Selected for Late-Breaking Oral Presentation at The Liver Meeting® 2019
Study Results Were Selected for Inclusion in the “Best of The Liver Meeting” Summary Slide Presentation
Poster Comparing DUR-928 Data to Historical Control Will Also be Presented
CUPERTINO, Calif., October 21, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the results from the recently completed Phase 2a study of DUR-928 in patients with alcoholic hepatitis (AH) have been selected for an oral presentation as part of the late-breaking session of The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), taking place on November 8-12, 2019, in Boston. This late-breaking abstract was one of only 29 late-breaking abstracts selected out of a total of approximately 3,000 abstracts that were accepted for presentation at the meeting. Additionally, the study results were selected for inclusion in the ‘Best of The Liver Meeting’ summary slide presentation in the alcohol-related liver disease category. Tarek Hassanein, M.D., one of the trial’s principal investigators, will deliver the oral presentation of the detailed trial results.
In a separate poster presentation, Craig McClain, M.D., will present additional comparative data from the Phase 2a clinical trial of DUR-928 and a control group from a contemporaneous AH trial conducted at University of Louisville.
“We look forward to Drs. Hassanein and McClain’s respective presentations of the positive results of our recently completed Phase 2a trial of DUR-928 in patients with alcoholic hepatitis at this year’s Liver Meeting, which is among the most prestigious gatherings of scientists and health care professionals dedicated to preventing and curing liver disease,” said James E. Brown, President and Chief Executive Officer of DURECT. “These compelling data provide strong rationale for continued development, and we plan to initiate a Phase 2b study for this difficult-to-treat and life-threatening condition next year.”
Oral Late-Breaker Presentation Details:
Title: Safety and Efficacy of DUR-928: A Potential New Therapy for Acute Alcoholic Hepatitis
Date: Tuesday, November 12, 2019
Time: 8:30 am Eastern Time
Location: Auditorium, Hynes Convention Center
Session Title: Late-Breaking Abstract Oral Session II
Presentation Type: Oral, Late-Breaker Session
Publication Number: LO9
Poster Presentation Details:
Title: DUR-928 Therapy of Acute Alcoholic Hepatitis: A Pilot Study
Date: Sunday, November 10, 2019
Time: Noon – 2:00 pm Eastern Time
Location: Hynes Convention Center, Hall B
Presentation Type: Poster Presentation
Publication Number: 1376
About the DUR-928 Alcoholic Hepatitis Phase 2a Trial
Patients with moderate and severe AH were treated with intravenously administered DUR-928 in this open label, dose escalation, multi-center, U.S., Phase 2a clinical trial. Final enrollment was 19 patients comprised of: 8 patients (4 moderate and 4 severe) dosed at 30 mg, 7 patients (3 moderate and 4 severe) dosed at 90 mg and 4 patients (4 severe) dosed at 150 mg. The study objectives included assessment of safety, PK and pharmacodynamic (PD) signals, including liver chemistry and biomarkers.
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 alcoholic hepatitis (AH) and acute kidney injury (AKI), chronic hepatic diseases such as nonalcoholic steatohepatitis (NASH), and inflammatory skin conditions such as psoriasis and atopic dermatitis. 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, 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
This press release includes forward-looking statements, including plans to conduct a Phase 2b study of DUR-928 in patients with alcoholic hepatitis next year, the potential use of DUR-928 to treat AH, AKI, chronic hepatic diseases such as NASH, and inflammatory skin disorders such as psoriasis and atopic dermatitis, as well as statements regarding the use of POSIMIR to treat post-surgical pain and the development of a SABER-based HIV investigational product. These forward-looking statements involve 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 the commencement of the Phase 2b trial of DUR-928 in AH, future trials of DUR-928 in AH may not yield positive results, potential adverse effects arising from the testing or use of DUR-928, the risk that the FDA may not approve the POSIMIR NDA, our ability to meet milestones in the development of an injectable SABER-based HIV investigational product and the risk that Gilead will terminate the development of this product, our ability to avoid infringing patents held by other parties and secure and defend patents of our own patents, and our ability to manage and obtain capital to fund our operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed with the Securities and Exchange Commission on August 2, 2019 under the heading "Risk Factors."
NOTE: POSIMIR® and SABER®, are trademarks of DURECT Corporation. 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
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