FREMONT, Calif., May 26, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that an article titled, “Long Term Safety, Tolerability, and Efficacy of Intracutaneous Zolmitriptan (M207) in the Acute Treatment of Migraine” was published in The Journal of Headache and Pain. This open-label, multicenter observational study was designed to evaluate the safety and efficacy of the repeated use of Qtrypta™ in adults with migraine who had historically experienced at least 2 migraine attacks per month. The tolerability and efficacy results in this long-term study were consistent with the results observed in the Phase 2/3 ZOTRIP study.
“The data published provide safety and efficacy findings for Qtyrpta™ when given repeatedly over the course of a year for the acute treatment of migraine,” said Don Kellerman, PharmD, vice president of clinical development and medical affairs of Zosano. “The similarity of these findings with those from the pivotal ZOTRIP study -- across primary and secondary outcome measurements -- provide supportive evidence regarding the performance of Qtrypta™, and if approved, its potential as a valuable long-term treatment option for patients.”
Stephanie J. Nahas, MD, MSEd, FAHS, FAAN, Associate Professor of Neurology at Thomas Jefferson University and Director of the Headache Medicine Fellowship Program, added, “In this long-term study, participants experienced on average about two migraine attacks per month and achieved meaningful relief with Qtrypta recurrently without serious side effects. If approved, I believe Qtrypta™ may be welcomed by many patients who need a better acute attack plan for their migraine.”
A total of 335 participants treated at least one migraine attack, and in total 5,963 migraine attacks were treated over the course of the study. The primary outcome measure was the percentage of participants experiencing treatment emergent adverse events over 12 months. Secondary outcomes included the percentage of migraine attacks for which pain freedom and most bothersome symptom freedom were achieved at two hours post-dose, and the percentage for which pain relief was achieved at two hours post-dose.
Participants achieved pain relief at two hours post-dose in 81% of migraine attacks, pain freedom in 44% of attacks, and most bothersome symptom freedom in 62% of attacks. The majority of participants experienced cutaneous application site reactions where the Qtrypta patch was applied, of which more than 95% were rated as mild. More than 80% of swelling and redness incidents were resolved (rated as zero) by 48 hours following application.
About Qtrypta™ (M207)
Qtrypta is Zosano’s proprietary investigational formulation of zolmitriptan delivered utilizing its proprietary transdermal microneedle system (the “System”) in development for the acute treatment of migraine. The System consists of titanium microneedles coated with drug, and in the case of Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug potentially dissolves and easily enters into the bloodstream. In February 2017, the company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8 mg dose of Qtrypta™ met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.
Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally. Migraine attacks are estimated to lead to lost productivity costs as high as $36 billion annually in the United States, including both direct and indirect costs. Zosano believes there is a significant need for new acute treatment options since 74% of migraine patients experience inadequate treatment response.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s transdermal microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan designed to be delivered via its transdermal microneedle system technology, as an acute treatment for migraine. Learn more at www.zosanopharma.com.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential benefits and availability of Qtrypta for patients and other future events and expectations described in this press release. 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 risks and uncertainties, without limitation, associated with the company’s ability to obtain additional cash resources to continue operations, 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 and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano 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