- Repeated Dosing of Qtrypta Over the Course of One Year Reaffirms Qtrypta is Effective and Well-Tolerated as an Acute Treatment for Migraine -

- Efficacy and Safety Profile Consistent in Sub Analyses of Patients Taking Concurrent Medications-

-Company is Preparing for a New Drug Application (NDA) Submission in Q4 2019-

FREMONT, Calif., Sept. 09, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced an oral presentation and two poster presentations of positive data from a one-year long-term safety study of Qtrypta™ for the acute treatment of migraine were presented at the 19th Congress of the International Headache Society (IHC) in Dublin, Ireland. The Qtrypta long-term safety study was an open-label trial evaluating the safety of a 3.8 mg dose of intracutaneous zolmitriptan in adults with migraine who had historically experienced at least 2 migraine attacks per month.

"With more than 6,000 migraine attacks treated in our clinical program, we have amassed a robust dataset on Qtrypta for the acute treatment of migraine, demonstrating its ability to consistently produce pain freedom and freedom from most bothersome symptoms," said Dr. Don Kellerman, vice president of clinical development and medical affairs. "Additionally, with favorable safety data in patients treated with Qtrypta repeatedly for up to one year, we believe we have a compelling body of evidence that supports our NDA filing, which we expect in the fourth quarter of this year."

An oral presentation by Stephanie Nahas, M.D., M.S.Ed., of Thomas Jefferson University reviewed an analysis of the approximately 6,000 attacks treated over one year with Qtrypta for the acute treatment of migraine. The administration of Qtrypta resulted in pain freedom for 44% of the attacks and freedom from patients' most bothersome symptoms for 62% of the attacks at two hours, which is consistent with the positive clinical results seen in the Phase 2/3 pivotal study.

Data from safety assessments demonstrated that Qtrypta was well-tolerated throughout the 12 months of repeated use. The most common adverse events were redness and swelling at the application site of which more than 95% were classified as mild.  80% of these site reactions were gone within 48 hours. Patients treated with Qtrypta reported less triptan-like neurological side effects than are typically found with the class, with less than 2% of patients reporting effects such as dizziness and paresthesia.

Stephanie Nahas, M.D., M.S.Ed., Associate Professor of the Department of Neurology and Program Director of the headache medicine fellowship at Thomas Jefferson University, added, "These data provide optimism for persons with migraine. Achieving rapid relief from attacks while minimizing side effects is critically important. Those who don't tolerate oral acute medication due to nausea, or who don't benefit from it due to slow onset or gastric stasis, need alternative routes of administration. Intranasal and injectable formulations can work rapidly, but they may lead to more adverse events, and some patients dislike injecting themselves or spraying medication into their noses. Qtrypta offers a fast-acting well-tolerated alternative without compromising efficacy."

Two late-breaking posters were also presented at the IHC congress. The first analyzed data from six patients enrolled in the long-term safety study who received prophylactic anti-CGRP antibodies and subsequently took Qtrypta for the acute treatment of their migraine attacks. Qtrypta was highly effective in relieving acute migraine symptoms with 76% achieving pain freedom and 88% reporting freedom from most bothersome symptoms at two hours. These preliminary data demonstrated that Qtrypta has the potential to be effective for the acute treatment of breakthrough migraine attacks in patients receiving prophylactic treatment with anti-CGRP antibody therapy.

The second poster presentation reviewed safety data from the 22 study participants who were on serotonergic drugs while taking Qtrypta for the acute treatment of migraine, and there were no reports of serotonin syndrome.

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Greg Kitchener
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