Zosano Pharma Corp (NASDAQ:ZSAN) reported that its lead candidate, M207, met both co-primary goals of pain freedom and most problematic symptom freedom at two hours in the recently closed ZOTRIP study. The ‘ZOTRIP’ pivotal efficacy trial was a multicenter, randomized, double-blind, placebo-controlled, dose-varying study assessing three doses, 1 mg, 1.9 mg and 3.8 mg of M207, a unique transdermal therapy, to placebo for a sole migraine attack.
As many as 589 subjects were registered at 36 sites in the U.S. The dose of 3.8 mg recorded significance in the secondary objective of pain freedom at 1 hour and 45 minutes and demonstrated durability of impact on pain freedom at 48 and 24 hours. Additionally, M207 was not linked with any Serious Adverse Events.
The details
The M207 3.8 mg dose recorded statistical significance for co-primary endpoints at 2 hours. Furthermore, secondary objective measuring pain freedom at increased time points for M207 3.8 mg dose demonstrated M207 superior to placebo showing an insignificant p-value not more than 0.05. M207 didn’t show any serious adverse events. Overall, 13 subjects recorded pain at the application site, which was reported as mild in all subjects. The most frequently seen adverse effect was redness at the application area.
Additionally, 5 subjects across M207-cured groups recorded dizziness versus 0% on placebo. Stewart Tepper, MD, expressed that the ZOTRIP trial was successful from the double perspectives of fulfilling the co-primary objectives and no serious adverse impacts. The study showed a statistically significant two-hour pain freedom response pace with a low placebo degree for the primary objective.
The data even indicate an effect durability at 48 and 24 hours, and significant pain freedom degree at 1 hour. If accepted by the FDA, M207 can become a vital treatment alternative for those suffering with migraine. ZOTRIP was advanced to be a dose-ranging trial, as well as a registration trial.
