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.

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Steve Kanaval: Portfolio Manager/Writer/ Market Analyst Steve began his career in the Trading Pits in Chicago making markets at the Chicago Mercantile Exchange (NYSE:CME) the Chicago Board of Trade and the CBOE in the early 80’s. He ran the Morgan Stanley Derivative Prop Trading for the firm specializing in Index Arbitrage. He continued his career as a Trader/Portfolio Manager for multiple Hedge Funds during the Internet Boom of the 90’s managing large portfolios. Steve is known as an expert in MicroCap Technology Stocks and the emerging Digital Currency markets as a Portfolio Manager for his Family Office. Steve has managed portfolio’s in volatile asset classes for 3 decades as a commodity trader, hedge fund manager and digital currency trader and miner. Steve publishes his views on the asset classes in a public forum and has published more than 10,000 articles simplifying these complex and volatile assets for readers. His work is published on multiple sites including Bloomberg,,, CryptoCurrencyNews as a paid contributor. His work includes research, journalism and archived video on important market volatility related to stocks, digital currency and other volatile misunderstood asset classes. He offers a humorous, unique insight and the related back stories and drivers for readers interested in volatility and emerging market assets. Full disclosure Steve is long 25 digital currencies and sits on the board of multiple public companies involved in digital currencies, and owns shares in these companies from time to time.