FREMONT, Calif., July 15, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the presentation of Migraine-ACT scores for Qtrypta™ therapy used over 6-12 months. The Migraine Assessment of Current Therapy (or Migraine-ACT) questionnaire is a standardized evaluation completed by patients to assess the effectiveness of a patient’s acute treatment of migraine therapy, with the highest achievable score being a four.
Data from 294 Qtrypta study participants were included in the analysis, which demonstrated that Migraine-ACT scores averaged greater than three throughout the trial, indicating an excellent response to Qtrypta therapy. At their 48-week visit, 89% of participants scored greater than three on the Migraine-ACT questionnaire, while more than 75% scored a four out of four, suggesting optimal acute treatment and no need to change that treatment. The detailed results were presented at AHS 61st Annual Scientific Meeting in a presentation entitled, “Assessing the Long-Term Effectiveness of Qtrypta using the Migraine-ACT; Correlation with Electronic Diary Scores.”
“Migraines can be extremely debilitating, lasting 4-72 hours with some patients experiencing four or more migraines a month,” said Stewart J. Tepper, M.D., Professor of Neurology at the Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Center at Dartmouth-Hitchcock Medical Center. “Many patients are unsatisfied with their current migraine therapy, underscoring the need for novel treatments. The positive Migraine-ACT scores that Qtrypta was able to achieve shows that the majority of patients treated with this medication had optimal results.”
The Migraine-ACT score is established using a questionnaire that assesses four key components of effective migraine treatment, including: 1) global assessment of relief (2-hour pain freedom); 2) headache impact; 3) consistency of response; and 4) emotional response. Migraine-ACT scores were evaluated at each clinical visit of the Qtrypta open-label, 12-month, long-term safety study for the treatment of migraine. Even at the last time point assessed (after 48 weeks of therapy), Qtrypta’s Migraine-ACT scores remained highly favorable across the four questions evaluated:
|Question||Proportion who answered "Yes"|
|Does your migraine medication work consistently, in the majority of your attacks?||96||%|
|Does the headache pain disappear within 2 hours?||85||%|
|Are you able to function normally within 2 hours?||84||%|
|Are you comfortable enough with your medication to be able to plan your daily activities?||94||%|
“These high Migraine-ACT scores indicate that patients found Qtrypta to be effective at addressing important migraine-related lifestyle limitations, even after being on therapy for up to a year,” said Don Kellerman, Vice President of Clinical Development and Medical Affairs. “These data reinforce our belief that Qtrypta has the potential to be an important treatment for patients suffering from migraines, and we look forward to including these results as part of our New Drug Application (NDA) filing to the FDA expected in the fourth quarter of this year.”
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.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of established molecules with known safety and efficacy profiles provides an increased benefit to patients, for markets where patients remain underserved by existing therapies. The company’s Adhesive Dermally-Applied Microarray (ADAM) technology consists of titanium microneedles coated with drug that can enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is QtryptaTM (M207), which is a proprietary formulation of zolmitriptan delivered via ADAM technology, as an acute treatment for migraine. The company is preparing to submit a New Drug Application (NDA) to the Food and Drug Administration for Qtrypta. The Company anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com.
This press release contains forward-looking statements regarding the expected satisfaction of patients on 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 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.
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