UPDATE: Auspex Pharma Expecting Top-Line Data from Phase 2/3 Trial for SD-809 During Mid 2015


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Auspex Pharmaceuticals,Inc. (Nasdaq: ASPX), a late clinical stage biopharmaceutical company focused ondeveloping and commercializing novel medicines for the treatment of orphandiseases, today announced the enrollment of the first two patients in amulti-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 Movementsin Tardive Dyskinesia) study, are expected in mid-2015."Tardive dyskinesia is a side effect of certain drug treatments forneurological disorders that is often permanent and there are currently noapproved therapeutics to treat it," said Michael Huang, M.D., Vice Presidentof Clinical Development at Auspex Pharmaceuticals. "This pivotal study willprovide us an opportunity to evaluate the therapeutic value of SD-809 as apotential new treatment for tardive dyskinesia."The ARM-TD Phase 2/3 clinical trial of SD-809 for the treatment ofdrug-induced tardive dyskinesia will involve approximately 90 subjects withmoderate to severe TD, who will be randomized 1:1 to receive SD-809 orplacebo. Patients will titrate to their optimal dosage over six weeks, and betreated at that dose for six weeks, for a total of 12 weeks of treatment. Theprimary efficacy endpoint will be the change in the Abnormal InvoluntaryMovement Scale (AIMS) from baseline to end therapy, which will be assessed bycentralized video rating. The safety endpoints include adverse events, vitalsigns, physical/neurological/laboratory examinations and ECGs. Eligiblesubjects who complete the Phase 2/3 clinical trial will be offered a long-termsafety follow-up. Auspex also plans to initiate an additional Phase 3 pivotalclinical trial of SD-809 for the treatment of TD in 2014."There is a serious and growing unmet medical need as tardive dyskinesia isone of the most debilitating and often irreversible side effects of dopaminereceptor blocking agents, which are increasingly being used in the UnitedStates for the treatment of psychosis, behavioral and sleep disorders, orgastrointestinal conditions," said Hubert Fernandez, M.D., Professor ofNeurology at the Center for Neurological Restoration at the Cleveland Clinicand Principal Investigator of the SD-809 ARM-TD clinical study.

27% profit every 20 days?

This is what Nic Chahine averages with his option buys. Not selling covered calls or spreads… BUYING options. Most traders don’t even have a winning percentage of 27% buying options. He has an 83% win rate. Here’s how he does it.


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