Form 8-K DURECT CORP For: Jan 11

 

 

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 11, 2016

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))

 

 

 

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Item 8.01 Other Events

On January 11, 2016, DURECT Corporation, a Delaware corporation (“DURECT”), issued a press release announcing the initiation of a single-ascending-dose Phase 1b clinical trial with DUR-928 in patients with nonalcoholic steatohepatitis (NASH). A copy of DURECT’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

 

99.1		Press Release of DURECT Corporation dated January 11, 2016

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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.

 

				DURECT Corporation
Date: January 11, 2016				By:		/s/ James E. Brown
						James E. Brown
						President and Chief Executive Officer

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INDEX TO EXHIBITS

 

Exhibit Number		Description
99.1		Press Release of DURECT Corporation dated January 11, 2016

Exhibit 99.1

DURECT Announces Initiation of DUR-928 Dosing in Patients

Single-Ascending-Dose Study in NASH Patients

CUPERTINO, CA, January 11, 2016 /PRNewswire / — DURECT Corporation (Nasdaq: DRRX) today announced it has initiated a single-ascending-dose Phase 1b clinical trial with DUR-928 in patients with nonalcoholic steatohepatitis (NASH). DUR-928 is an endogenous, small-molecule, new chemical entity (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and NASH, and in acute organ injuries such as acute kidney injury (AKI).

“We are excited to have the DUR-928 Chronic Metabolic Disease program advance into patient studies,” said James E. Brown, President and CEO of DURECT. “DUR-928 has demonstrated no adverse events in our previous studies with healthy volunteers. Gathering data from NASH patients in this trial will position the program for subsequent clinical studies.”

Phase 1b Oral Study

This Phase 1b trial of DUR-928 is a dose ranging, single-ascending-dose safety and pharmacokinetic study of DUR-928 of subjects with NASH and matched control subjects. This study will be conducted in three successive cohorts evaluating three single-dose levels of oral DUR-928. After a PK/safety review at each dose, the study can proceed to a successively higher dose. Assuming all three cohorts are dosed, the study will comprise approximately 48 subjects, of which approximately 30 will have received DUR-928. The study is being conducted in Australia and we anticipate that it will be completed in the first half of 2016.

About DURECT Corporation

DURECT is a biopharmaceutical company focused on two areas of active drug development: new therapeutics based on its proprietary drug delivery platforms and new chemical entities derived from its Epigenomic Regulator Program. Its drug development expertise is being applied primarily to the fields of pain management, CNS disorders, acute organ injury and metabolic diseases such as NAFLD/NASH. DURECT’s proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as improved abuse deterrence, convenience, adherence, efficacy and safety for small molecule and biologic drugs. Late stage development programs of this nature include POSIMIR™ (SABER^®-Bupivacaine) and REMOXY^® (ORADUR^®-oxycodone). DURECT’s Epigenomic Regulator Program includes the lead molecule DUR-928 in Phase 1 development. DUR-928 is an endogenous small molecule that modulates lipid homeostasis, inflammation and cell survival. For more information, please visit www.durect.com.

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About DURECT’s Epigenomic Regulator Program

DURECT’s Epigenomic Regulator Program is a collaborative effort now in its fourth year between DURECT and the Department of Internal Medicine at Virginia Commonwealth University (VCU), the VCU Medical Center, and the McGuire VA Medical Center. During the course of this program, a number of compounds that may have therapeutic utility have been identified, including the lead molecule DUR-928. DURECT holds the exclusive worldwide right to develop and commercialize DUR-928 and related molecules discovered in the program. Several clinical indications are currently under exploration, including orphan and non-orphan diseases that are both acute and chronic in nature.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT’s Epigenomic Regulator Program and product candidate DUR-928, including the attributes, potential therapeutic effects for DUR-928 and other compounds identified during the course of the program, our development plans for DUR-928, and the timing of clinical trials, as well as the potential of our other products in development, 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, DURECT’s ability to design, enroll, conduct and complete clinical trials, whether additional human trials for DUR-928 will demonstrate biological activity shown in animal trials and/or will identify safety issues, DURECT’s ability to complete the design, development, and manufacturing process development of DUR-928 and other NCE product candidates, obtain product and manufacturing approvals from regulatory agencies and manufacture and commercialize product candidates, and achieve marketplace acceptance of product candidates. Further information regarding these and other risks is included in DURECT’s Form 10-Q dated November 3, 2015 filed with the Securities and Exchange Commission under the heading “Risk Factors.”

NOTE: POSIMIR™ is a trademark of DURECT Corporation. REMOXY, POSIMIR and DUR-928 are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

 

SOURCE:		DURECT Corporation
CONTACT:		Matthew J. Hogan, Chief Financial Officer, DURECT 408-777-4936

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