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Zosano Announces Publication of Most Bothersome Symptom Data from the ZOTRIP Pivotal Study in Headache: The Journal of Head and Face Pain
FREMONT, Calif., May 23, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using its proprietary Adhesive Dermally-Applied Microarray (“ADAM™”) technology, today announced that Headache, the Journal of Head and Face Pain, has published the post-hoc analysis on the use of most bothersome symptom (MBS) as a co-primary endpoint from the Company’s ZOTRIP pivotal study.
Headache published the paper titled “Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post-Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial”. The paper analyzes the positive MBS results from Zosano’s ZOTRIP pivotal study, a multi-center, double-blind, placebo-controlled trial demonstrating the efficacy and safety of M207, Zosano’s novel proprietary formulation of zolmitriptan using its ADAM technology. The ZOTRIP pivotal study, evaluating ADAM zolmitriptan for the acute treatment of migraine, was one of the first large studies to incorporate MBS freedom and pain freedom as co-primary endpoints, per recently issued guidance by the US Food and Drug Administration. MBS freedom at two hours was observed in 68% of M207 3.8 mg subjects as compared to 43% of placebo subjects (P < .01).
“We are pleased to see this aspect of the ZOTRIP pivotal study published and hope that the results and discussion will be helpful to others designing and interpreting trials of acute treatment of migraine,” said Dr. Don Kellerman, Vice President of Clinical Development. “Since the time of our manuscript submission, several other trials have reported results using these coprimary endpoints, and we look forward to their publication.”
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to subjects using our proprietary ADAM technology. The Company previously announced positive results from our ZOTRIP pivotal study that evaluated M207, which is our proprietary formulation of zolmitriptan delivered via our ADAM technology, as an acute treatment for migraine, and is currently conducting a long-term safety study of M207. Zosano is focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to subjects, for markets where subjects remain underserved by existing therapies. The Company anticipates that its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.
M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary ADAM technology. Zosano's ADAM technology consists of titanium microprojections coated with drug, and in the case of M207, our formulation of zolmitriptan. Our ADAM technology delivers drug by abrading the stratum corneum and allowing drug to be absorbed into the microcapillary system of the skin. 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 an NDA for M207 in the fourth quarter of 2019.
This press release contains forward-looking statements regarding the timing of expected clinical development milestones, sufficiency of our capital resources and need for future funding 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 we believe 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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