Zosano Pharma Confirms Plan to Move Forward with Pharmacokinetic Study Following Protocol Review by FDA
Zosano Pharma Corporation (NASDAQ:ZSAN) has partnered with Worldwide Clinical Trials to conduct a pharmacokinetic (PK) study for its Qtrypta™ (zolmitriptan transdermal microneedle system). The FDA provided feedback on the study protocol, which will involve 48 healthy volunteers. The PK study is set to initiate in June 2021 and complete by Q3 2021, with NDA resubmission anticipated by the end of the year, pending positive results. This study aims to address FDA's remaining clinical requests, potentially expanding treatment options for migraine patients.
- Collaboration with Worldwide Clinical Trials could enhance study execution efficiency.
- Expected study completion and data availability by Q3 2021 may facilitate timely NDA resubmission.
- Completion of the PK study could lead to Qtrypta's approval as a new migraine treatment option.
- Dependence on positive study results for NDA resubmission may pose risks.
- Potential delays or unforeseen issues in the PK study could impact timelines.
– 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, QtryptaTM 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.
Forward-Looking Statements
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, statements regarding the company’s plans for and the anticipated timing with respect to the PK study, the expected timing of the resubmission of the company’s Qtrypta NDA to the FDA, 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.
Zosano Contacts:
Christine Matthews
Chief Financial Officer
510-745-1200
Zosano PR:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
FAQ
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