Zosano Pharma Announces the Presentation of Multiple Positive Datasets from the Qtrypta™ Long-Term Safety Study at the Congress of the International Headache Society
- 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-
“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.
An oral presentation by
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.
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.
About Long-Term Safety Study
The open-label study evaluated the safety of 3.8 mg of intracutaneous zolmitriptan in adults with migraine who had historically experienced at least 2 migraine attacks per month. There were no maximum treatment limits. The primary outcome measure was long-term safety as measured by the incidence of adverse events over a 12-month period. Secondary outcome measures included efficacy measures such as pain freedom and freedom from most bothersome symptoms at two hours. The study evaluated over 342 adults with migraine at 31 sites in the U.S.
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
This press release contains forward-looking statements regarding the efficacy and safety of 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.
Chief Financial Officer
Source: Zosano Pharma Corporation