Zosano Pharma (ZSAN) Presents Early-Onset of Action Data for Qtrypta in Acute Treatment of Migraines
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Zosano Pharma Corporation (NASDAQ: ZSAN), a clinical-stage biopharmaceutical company, today announced that early onset of action data for Qtrypta™, Zosano’s investigational therapy for the acute treatment of migraine formulated utilizing its microneedle system, were presented at the Annual Headache Cooperative of the Pacific Winter Conference.
“We believe Qtrypta shows tremendous potential to become an attractive therapeutic alternative to acutely treat migraines,” said Steven Lo, President and CEO of Zosano. “As our lead program utilizing our novel microneedle patch technology designed to deliver drug through the skin, Qtrypta has demonstrated rapid pain relief in patients who are often too nauseated to take oral medications which take time to travel to the gastrointestinal tract before providing pain relief.”
In a post-hoc retrospective analyses of data from the previously published ZOTRIP trial involving 365 subjects who received Qtrypta 3.8 mg or placebo, of 82 Qtrypta-treated subjects, 38 reported pain relief at 30 minutes, and 28 of the 38 subjects (74%) were pain free at two hours. All 6 subjects treated with Qtrypta who reported pain freedom at 30 minutes were pain-free at two hours. This compares to nine of 26 subjects (35%) in the placebo group (n=77) who reported pain relief at 30 minutes that were pain free at 2 hours, and 1 of 2 subjects that were pain free at 30 minutes being pain free at 2 hours.
These data describe therapeutic gain at 30 minutes, a measure consistent with recently published criteria for evaluating early onset of action published in Cephalalgia, an International Journal of Headache, by Pfelt-Hansen and Diener. The post-hoc analysis of data from the ZOTRIP trial suggests that the therapeutic gain for pain freedom, instead of pain relief, may be a more reliable endpoint for evaluating early onset of action.
“Qtrypta demonstrated rapid and robust improvement in the rates of pain relief and pain freedom in two hours. I believe that rapid onset of meaningful and sustained improvement is of utmost importance to patients suffering from migraines,” said Dr. Deborah Friedman, Professor of Neurology and Ophthalmology at the University of Texas Southwestern Medical Center.
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