FREMONT, Calif., Nov. 08, 2016 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging CNS company focused on providing rapid symptom relief to patients using the Company's proprietary intracutaneous delivery system, today announced completion of enrollment in its registration-enabling, pivotal efficacy trial (the Zotrip trial), of M207 for the treatment of acute migraine. "The completion of enrollment in the Zotrip study is a major milestone for the Company and bolsters our confidence in the previously announced availability of trial data in the first quarter of 2017," commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. "The enrollment pace is also indicative of the urgent need for improved treatment options for those suffering with acute migraine." About the Zotrip Trial The pivotal efficacy trial is a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0 mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Patients were recruited and enrolled in the Zotrip trial at 36 centers across the United States. Subjects recruited into the Zotrip trial had a history of at least one year of episodic, acute migraines with or without aura. Upon recruitment, the subjects enter a run-in period that ensures they meet the key eligibility criteria of 2-8 migraine attacks per month, which is documented using an electronic diary. Successfully screened subjects are then randomized into the treatment/dosing period in which they have 8 weeks to confirm and receive blinded treatment for a single migraine attack. In regards to the Company's discussions with the FDA and the FDA's October 2014 Draft Guidance —"Migraine: Developing Drugs for Acute Treatment," the co-primary endpoints of this study are:
Pain freedom at 2 hours post-dosing, and
Freedom from each subject's most bothersome symptom at 2 hours post-dosing.
The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study, will be sufficient for approval under a 505(b)(2) pathway. The Company intends to conduct the safety study after completion of the Zotrip trial.