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Auspex Pharmaceuticals Initiates Second Pivotal Clinical Trial for SD-809 in Tardive Dyskinesia

LA JOLLA, Calif., Oct. 30, 2014 (GLOBE NEWSWIRE) -- Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced the enrollment of the first patient in a multi-center Phase 3 clinical trial of its investigational drug SD-809 (deutetrabenazine) for the treatment of people with tardive dyskinesia. The trial, designated the AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) study, is the company's second pivotal clinical trial to evaluate SD-809 in people with tardive dyskinesia, a debilitating and often irreversible movement disorder. Top-line data from the AIM-TD study are expected in 2016. The first pivotal trial of SD-809, ARM-TD, is a Phase 2/3 study that was initiated earlier this year to evaluate SD-809 as a treatment for tardive dyskinesia. Top-line results from the ARM-TD study are expected in mid-2015.

"The initiation of AIM-TD represents another important milestone for Auspex as we continue to advance the development of SD-809 as a treatment for people with tardive dyskinesia," said Michael Huang, M.D., vice president of clinical development at Auspex Pharmaceuticals. "The AIM-TD trial, along with the ARM-TD trial, will provide us an opportunity to evaluate the therapeutic value of SD-809 as a potential new treatment for people battling this debilitating disorder."

The AIM-TD trial will involve approximately 200 people with tardive dyskinesia. People enrolled in this double-blind, placebo-controlled, parallel group study will be randomized 1:1:1:1 to receive 3 fixed doses of SD-809 or placebo for 12 weeks of treatment. With the exception of fixed dosing in the AIM-TD study, the design of this second Phase 3 trial is similar to that of the ongoing ARM-TD trial. In both pivotal trials, the primary efficacy endpoint will be the change in the Abnormal Involuntary Movement Scale (AIMS) from baseline to week 12, which will be assessed by a blinded, centralized video rater. The safety endpoints will include adverse events, vital signs and electrocardiograms (ECGs), as well as physical, neurological and laboratory examinations. Auspex also intends to offer up to one year of open-label SD-809 treatment for eligible subjects who successfully complete the AIM-TD trial.

The ARM-TD and AIM-TD pivotal studies are being conducted at sites in the Unites States and Europe. Data from these studies are expected to support the submission of a New Drug Application (NDA) for SD-809 as a treatment for tardive dyskinesia. Contingent upon successful completion of both studies, the company plans to file an NDA in 2016.

"There are currently no approved therapies in the United States to treat tardive dyskinesia, a huge and growing unmet medical need," said Karen Anderson, M.D., associate professor, psychiatry and neurology at the Georgetown University and principal investigator of the SD-809 AIM-TD clinical study. "There is an urgent need for a safe and effective treatment for these patients, and we are pleased to be working with Auspex to advance SD-809 for the potential treatment of tardive dyskinesia."

Auspex has also expanded clinical studies evaluating SD-809 in other movement disorders:

Huntington's Disease:

  • Target enrollment in the open-label ARC-HD Switch clinical trial of SD-809 for the potential treatment of chorea associated with Huntington's disease has been completed. In August 2014, the company announced the completion of enrollment in the First-HD Phase 3 registration clinical trial of SD-809. Auspex remains on track to announce the topline results from both of these trials in December 2014.

Tourette Syndrome:

  • Auspex plans to expand its ongoing Phase 1b open-label preliminary efficacy and safety clinical trial for the potential treatment of tics associated with Tourette syndrome to study the pharmacokinetics in adolescents. These additional data are expected to further support the dosing assumptions and design elements of a randomized, controlled trial in this patient population and accelerate the development of SD-809 in this indication. Topline data are expected in the first half of 2015.

Thorough QT Study:

  • Auspex is currently undertaking a thorough QT study of SD-809 in healthy subjects to further evaluate the potential effect of SD-809 on cardiac ventricular repolarization, specifically the QT-interval. A Phase 1 clinical trial, which evaluated drug interactions, had previously shown that SD-809 produced a reduced QT interval prolongation as compared to tetrabenazine at comparable levels of systemic exposure. Topline results from this QT study are expected in the first quarter of 2015.

About Auspex Pharmaceuticals

Auspex Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines for hyperkinetic movement disorders and other rare diseases. Auspex employs its proprietary technology to create patent-protected, new chemical entities from known, clinically proven pharmacologics. The company's lead product SD-809 is in final stages of development for the treatment of chorea associated with Huntington's disease, a neurodegenerative movement disorder that impacts cognition, behavior and movements. In addition, Auspex is investing in the broad potential of SD-809 for the treatment of other movement disorders, including tardive dyskinesia and tics associated with Tourette syndrome. The company's pipeline also includes SD-560, being developed for fibrotic conditions. For more information, please visit the company's website at 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.

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Source:Auspex Pharmaceuticals, Inc.