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Long-term one-year dosing reaffirmed well-tolerated safety profile
Qtrypta showed robust and rapid relief of migraine pain, an effect that was consistent throughout the chronic treatment period
NDA submission expected in Q4 2019 for the first intracutaneous delivery system
FREMONT, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (ZSAN), a clinical-stage biopharmaceutical company, today announced the completion of the second and final goal of the long-term safety study for Qtrypta, in which patients treated migraine attacks over a one year period. The long-term data generated in this trial reinforced the well-tolerated safety profile and strong efficacy results previously reported in the six-month dosing portion of this safety study and in the randomized Phase 2/3 ZOTRIP pivotal study. Throughout the clinical program, over 5,800 migraine attacks have been treated with Qtrypta to date.
“Successfully concluding our Phase 3 program for Qtrypta and observing consistent long-term safety and efficacy results are exciting milestones for Zosano,” said John Walker, chairman, president and chief executive officer of Zosano. “We look forward to continued interactions with the FDA as we prepare to submit a New Drug Application in the fourth quarter of this year for Qtrypta. We believe Qtrypta will be an important alternative for patients whose migraine disease is not well managed with other therapies. We view Qtrypta as the first of many therapies that can be expertly formulated with our novel and proprietary technology. If approved by the FDA, Qtrypta would be the first marketed product using intracutaneous delivery.”
“With these additional data showing long-term tolerability and robust efficacy, I believe Qtrypta, if approved, will be an important and attractive treatment for my patients with migraines,” said Deborah Friedman, M.D., M.P.H., chief of the Division of Headache Medicine and founding director of the Headache and Facial Pain Program, UT Southwestern Medical Center. “I am especially excited by the novel microneedle patch technology that delivers drug through the skin for rapid pain relief in patients who are often too nauseated to take oral medications and can’t wait for drugs to travel through the gastrointestinal tract before providing pain relief.”
The Qtrypta long-term safety trial is an open-label study evaluating the safety of the 3.8 mg dose of intracutaneous zolmitriptan in adults with migraine who have historically experienced at least 2 migraine attacks per month. There were no maximum treatment limits. The study evaluated over 150 adults with migraine disease for six months, and more than 50 patients for a year at 31 sites in the U.S.
Of more than 5,800 migraines treated, investigators reported 832 adverse events, of which 298 were reported as application site reactions and 161 were reported as triptan related adverse events.
Observational efficacy parameters continued to demonstrate a rate of pain freedom at two hours following patch application of approximately 44% and most bothersome symptom freedom of approximately 68%, while pain relief at two hours was reported at 81% of migraine attacks treated.
About Qtrypta (M207)
Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary technology. Zosano's intracutaneous drug delivery technology consists of titanium microneedles coated with drug, and in the case of Qtrypta, its formulation of zolmitriptan. The drug-coated microneedles penetrate through the epidermis, where the investigational drug is dissolved and enters 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 February 2019, the company announced results of its long-term safety study evaluating Qtrypta and its expectations to file an NDA for Qtrypta in the fourth quarter of 2019.
This press release contains forward-looking statements regarding the expected timing of a New Drug Application for Qtrypta (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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