Zosano Pharma Corp (NASDAQ:ZSAN) gave investors quite an encouraging update today: the drug maker has met a big clinical milestone in its long-term safety trial evaluating lead migraine asset M207. In reaction to the news that the 100th patient is now enrolled for the open label M207-ADAM trial, ZSAN shares have been sent vaulting 15%.
Specifically, the long-term safety study investigates just how safe is the company’s 3.8 mg dose of zolmitriptan in migraine patients who have in the past experienced a minimum of 2 migraines each month.
Patients are expected to treat a minimum of two migraines per month, with no maximum treatment limits. The study will evaluate at least 150 patients for six months, and 50 patients for a year at 31 sites in the U.S. The Company may elect to enroll more than the required number of patients to ensure a robust data set, and achievement of the requisite number of evaluable patients completing 6 and 12 months. The primary objective of the study is to assess safety of M207 during repeated use over 6 and 12 months. M207-ADAM study updates include:
- 103 patients have qualified and received study drug
- additional 77 patients have signed consents and are in the 2-week run-in evaluation period
- study patients have treated 278 migraines since study initiation
“Our clinical investigators are doing an excellent job in patient recruitment and follow-up and we are pleased with the study’s progress,” said Dr. Donald Kellerman, Zosano’s VP, Clinical Development and Medical Affairs. “We have reached an important milestone in our M207-ADAM study. With the 100th patient enrolled, we project that 12 months from now, at least 50 of these patients will complete the study and have treated at least two migraines per month. Our investigator partners will continue enrolling to reach a sufficient number of patients such that 150 patients will complete six months, but the clinical completion of the study will occur after 50 subjects have completed a year, which we estimate to be in one year.”