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Auspex Pharmaceuticals Completes Enrollment In Phase 3 Registration Clinical Trial Of SD-809 In Chorea Associated With Huntington's Disease



8/18/2014 7:03:33 AM

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LA JOLLA, Calif., Aug. 18, 2014 (GLOBE NEWSWIRE) -- Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a late clinical stage biopharmaceutical company focused on developing and commercializing novel medicines for the treatment of orphan diseases, today announced that it has completed the enrollment of the planned 90 patients in its Phase 3 registration clinical trial (First-HD) of SD-809 for the potential treatment of chorea associated with Huntington's disease (HD). The company expects to announce the topline data from this study in the fourth quarter of 2014.

"The completion of enrollment of the First-HD trial represents an important milestone for both the company and the SD-809 program," said David Stamler, M.D., Chief Medical Officer of Auspex. "We are gratified by the interest and support shown by the HD patients, the care givers, the HD advocacy groups and the treating physicians in this trial. We believe that SD-809 has the potential to be an important new treatment for these patients."

About First-HD

First-HD is a randomized, double-blind, placebo-controlled, parallel-group trial of SD-809 in 90 patients with chorea associated with Huntington's disease and is designed to evaluate, and generate label information for, the safety, tolerability and efficacy of SD-809 for treating chorea associated with Huntington's disease. If the primary endpoint of First-HD is met, the Company anticipates submitting a Section 505(b)(2) new drug application, for SD-809 to the U. S. Food and Drug Administration (FDA). In addition, the Company has initiated an open-label clinical trial, which is referred to as ARC-HD that will evaluate long-term safety as well as provide guidance on how to switch patients who are currently on tetrabenazine to SD-809. These studies are being conducted with the Huntington Study Group. More information about clinical trials evaluating SD-809 in First-HD and ARC-HD can be found at www.huntington-study-group.org or by calling 800-487-7671.

About Auspex Pharmaceuticals

Auspex Pharmaceuticals is a late clinical stage biopharmaceutical company focused on the development and commercialization of novel medicines for the treatment of orphan diseases. Auspex's pipeline includes product candidates to address unmet medical needs in hyperkinetic movement disorders, such as chorea associated with Huntington's disease, tardive dyskinesia and Tourette syndrome, as well as fibrotic indications, including idiopathic pulmonary fibrosis (IPF) and other orphan conditions. Auspex's lead product candidate, SD-809 (deutetrabenazine), is in a Phase 3 registration clinical trial for the treatment of chorea (abnormal involuntary movements) associated with Huntington's disease. Auspex has initiated a Phase 2/3 clinical trial of SD-809 in tardive dyskinesia and a Phase 1b study in Tourette syndrome. Auspex also is evaluating SD-560 (deuterium-containing form of pirfenidone) in a Phase 1 clinical trial. Auspex has employed its deuterium chemistry approach to optimize other compounds in its portfolio that are at various stages of development. For further information, please visit the company's website www.auspexpharma.com.

Forward Looking Statements

Statements made in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Auspex's ability to successfully complete its ongoing clinical trials and development programs and Auspex's ability to obtain regulatory approval for its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: Auspex's future preclinical studies and clinical trials may not be successful; changes in regulatory requirements in the United States and foreign countries may prevent or significantly delay regulatory approval of Auspex's product candidates; Auspex may change its plans to develop and commercialize its product candidates; the FDA may not agree with Auspex's interpretation of the data from clinical trials of its product candidates; Auspex may decide, or the FDA may require Auspex, to conduct additional clinical trials or to modify Auspex's ongoing clinical trials; Auspex may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Auspex's ability to obtain regulatory approval; the third parties with whom Auspex has partnered with for the development of its product candidates and upon whom Auspex relies to conduct its clinical trials and manufacture its product candidates may not perform as expected; Auspex's product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of Auspex's product candidates could delay or prevent regulatory approval or commercialization; Auspex may be unable to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; Auspex's ability to obtain additional financing; and the accuracy of Auspex's estimates regarding expenses, future revenues and capital requirements. All forward-looking statements contained in this press release speak only as of the date on which they were made. Other risks and uncertainties affecting Auspex are described more fully in Auspex's filings with the Securities and Exchange Commission. Auspex undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: Corporate Communications Contact: Jason Spark at Canale Communications, Inc. jason@canalecomm.com 619-849-6005 Help employers find you! Check out all the jobs and post your resume.

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