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FREMONT, Calif., April 16, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, today announced the peer-reviewed publication of a review and analysis of recently-completed trials using newly FDA-recommended endpoints in the acute treatment of migraine. The review article, led by Stanford Assistant Professor of Neurology, Nada Hindiyeh, MD., was published in Headache, titled “Review of Acute Treatment of Migraine Trial Results With the New FDA Endpoints: Design Implications for Future Trials.”
In this analysis, researchers reviewed eight published trials designed in accordance with the Guidance for Industry, “Migraine: Developing Drugs for Acute Treatment”, finalized in February 2018, that recommended using co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at 2-hours post-treatment. Using the placebo response rates from these various trials, the authors were able to calculate required sample sizes for future trials and compare these calculations to the sample sizes actually used in completed trials. Included in this analysis was Zosano’s ZOTRIP trial, in which 41.5% of subjects in the QTRYPTA 3.8mg arm achieved pain freedom at two hours and 68.3% achieved freedom from their MBS at two hours, as compared to 14.3% and 42.9% respectively in the placebo group. Furthermore, the analysis showed that the average response rates across all active groups of these trials were 30.4% for pain freedom and 46.7% for MBS freedom, compared to 16.8% and 33% respectively for the placebo groups. Using these averages, future trials would need to enroll approximately 180 subjects per arm to demonstrate statistical significance with 80% power. Researchers noted that the majority of the completed trials enrolled far more than this, with subjects per group reaching as high as 751.
“It’s an exciting time in migraine treatment with so many acute treatments on the horizon,” said Dr. Hindiyeh, lead author on the manuscript. “These data may help to guide future migraine researchers in the design of migraine trials, and clinicians in interpreting these new endpoints on drug labels.”
About Qtrypta (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology. Zosano's ADAM technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles penetrate into the epidermis and dermis, where the investigational drug is dissolved and enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta 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 Qtrypta and expects to file an NDA for Qtrypta in the fourth quarter of 2019.
This press release contains forward-looking statements regarding the expected timing of an NDA for Qtrypta 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," "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, without limitation, risks and uncertainties 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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