FREMONT, Calif., Jan. 31, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, today announced the peer-reviewed publication of a post-hoc analysis of its pivotal Phase 2/3 (ZOTRIP) study in Headache: The Journal of Head and Face Pain, titled “Efficacy of ADAM Zolmitriptan for the Acute Treatment of Difficult to Treat Migraines.”
In this post-hoc analysis, researchers examined the efficacy of Qtrypta™ in treating subsets of patients whose migraines have traditionally been difficult-to-treat and have been associated with poorer outcomes when treated with oral medications. Migraine characteristics including severe pain, duration of migraine of more than 2 hours, awakening with migraine, and the presence of nausea are established factors that predict a poorer response to traditional migraine treatment.
Results from these post-hoc analyses using the same clinical endpoints of pain freedom and most bothersome symptom (MBS) at 2 hours from the ZOTRIP study demonstrated patients with these difficult-to-treat migraine characteristics had uniformly better headache responses compared to patients who received placebo.
“We are pleased with the results of this retrospective analysis, which demonstrate that Qtrypta may be an effective acute treatment for patients exhibiting migraine characteristics that historically have been difficult to treat,” said Dr. Stewart Tepper, M.D., Professor of Neurology at the Geisel School of Medicine at Dartmouth. “Qtrypta was found to have clinically and statistically significant impact on pain freedom and most bothersome symptom freedom across the entire patient population in the ZOTRIP study, and the results from these subset analyses support the potential for Qtrypta to provide patients with a novel acute treatment that provides rapid relief of pain in patients with these more refractory migraine subtypes.”
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 through the epidermis, 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 quarterly report on Form 10-Q. 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.
Chief Financial Officer