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Auspex Pharmaceuticals Initiates Pivotal Phase 2/3 Clinical Trial For SD-809 In Tardive Dyskinesia


7/17/2014 6:41:54 AM

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LA JOLLA, Calif., July 17, 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 the enrollment of the first two patients in a multi-center pivotal Phase 2/3 clinical trial of its investigational drug, SD-809 (deutetrabenazine), for the treatment of tardive dyskinesia (TD). Top-line data from the trial, designated the ARM-TD (Aim to Reduce Movements in Tardive Dyskinesia) study, are expected in mid-2015.

"Tardive dyskinesia is a side effect of certain drug treatments for neurological disorders that is often permanent and there are currently no approved therapeutics to treat it," said Michael Huang, M.D., Vice President of Clinical Development at Auspex Pharmaceuticals. "This pivotal study will provide us an opportunity to evaluate the therapeutic value of SD-809 as a potential new treatment for tardive dyskinesia."

The ARM-TD Phase 2/3 clinical trial of SD-809 for the treatment of drug-induced tardive dyskinesia will involve approximately 90 subjects with moderate to severe TD, who will be randomized 1:1 to receive SD-809 or placebo. Patients will titrate to their optimal dosage over six weeks, and be treated at that dose for six weeks, for a total of 12 weeks of treatment. The primary efficacy endpoint will be the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to end therapy, which will be assessed by centralized video rating. The safety endpoints include adverse events, vital signs, physical/neurological/laboratory examinations and ECGs. Eligible subjects who complete the Phase 2/3 clinical trial will be offered a long-term safety follow-up. Auspex also plans to initiate an additional Phase 3 pivotal clinical trial of SD-809 for the treatment of TD in 2014.

"There is a serious and growing unmet medical need as tardive dyskinesia is one of the most debilitating and often irreversible side effects of dopamine receptor blocking agents, which are increasingly being used in the United States for the treatment of psychosis, behavioral and sleep disorders, or gastrointestinal conditions," said Hubert Fernandez, M.D., Professor of Neurology at the Center for Neurological Restoration at the Cleveland Clinic and Principal Investigator of the SD-809 ARM-TD clinical study.

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 plans to initiate a Phase 3 pivotal clinical trial of SD-809 in tardive dyskinesia. Auspex also plans to evaluate 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 U.S. Food and Drug Administration (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
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