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Zosano Treats over 4,000 Migraines and Reaches an Important Goal in M207-ADAM Long-term Safety Study
FREMONT, Calif., Oct. 23, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, today announced that more than 150 evaluable subjects have completed their six month visit in the M207-ADAM study (the "Study"), a long-term, open-label safety study for the acute treatment of migraine. This marks completion of the first major goal of this study, a defined data set per the protocol in which 150 subjects must treat repeatedly for six months and 50 subjects must treat repeatedly for one year.
No unexpected safety signals have been identified during the first six months of the trial and there have been no study drug related serious adverse events. The total number of investigator reported adverse events, with 4,000 applications to date, is 625 of which 232 are reported as skin site reactions and 120 triptan related adverse events. The remainder of the adverse events (273) include nasal congestion, gastrointestinal disorders, appetite suppression, respiratory tract infections and insomnia, among others. Efficacy parameters, while observational in the context of this open label safety study, continue to remain similar to the data from the pivotal ZOTRIP trial. The rate of pain freedom at two hours following patch application is approximately 43% and most bothersome symptom freedom is approximately 68%, while pain relief at two hours post treatment is reported at 81% of migraine attacks treated.
“With over 4,000 migraine attacks treated to date, we don't foresee any unanticipated safety signals developing during the remainder of the trial,” commented Dr. Don Kellerman, vice president of clinical development of Zosano. “We anticipate our goal of 50 subjects treated for one year will be complete in the first quarter of 2019.”
M207 is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections (microneedles) coated with drug, and in the case of M207, its formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file a New Drug Application for M207 in the fourth quarter of 2019.
This press release contains forward-looking statements regarding the expected timing of a New Drug Application for M207 and other future events and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties, without limitation, associated with the process of discovering, developing and commercializing products that are safe and effective for use as human therapeutics, risks inherent in the effort to build a business around such products and other risks and uncertainties described under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, we cannot in any way guarantee that the future results, level of activity, performance or events and circumstances reflected in forward-looking statements will be achieved or occur. All forward-looking statements are based on information currently available to Zosano and Zosano assumes no obligation to update any such forward-looking statements.
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