– Company Establishes Agreement with Worldwide Clinical Trials to Conduct PK Study –

– Anticipates initiating PK Study in June and Completion in Q3 2021 –

FREMONT, Calif., April 26, 2021 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the company has received feedback from the U.S. Food and Drug Administration (“FDA") Division of Neurology II (the “Division”) on the protocol for the pharmacokinetic (“PK”) study required to support the resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”).

Separately, Zosano announced that it has established an agreement with Worldwide Clinical Trials (“Worldwide”), one of the industry’s leading global, midsized, full-service contract research organizations, to conduct the study, which is expected to involve 48 healthy volunteers to generate comparative pharmacokinetic and safety data. The company expects the study to begin in June and to be completed with data available in the third quarter of 2021. Subject to positive data, Zosano expects to resubmit its NDA for Qtrypta™ by the end of 2021.

“We believe that this study can be executed quickly and will address the last remaining clinical request from FDA regarding the resubmission of our NDA for Qtrypta™,” said Donald Kellerman, vice president, Clinical Development and Medical Affairs at Zosano. “We look forward to initiating and completing the PK study, ultimately resubmitting our NDA and, if approved, potentially making Qtrypta available broadly as a therapeutic option for patients with debilitating migraines. Worldwide has significant experience with advanced drug delivery systems and we look forward to working with them.”

“We are delighted to collaborate with Zosano to run this important PK study in support of its expected NDA resubmission,” added Mike Mencer, executive vice president and general manager, Early Phase Drug Development for Worldwide. “This mode of drug delivery has great potential. Our mission is to work with passion and purpose every day to improve lives, and, if approved, Qtrypta^TM would be the only transdermal microneedle patch treatment option available to treat people suffering from migraines. We are excited to be part of this development.”

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.