FREMONT, Calif., June 17, 2016 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical stage specialty pharmaceutical company with proprietary technology for the dermal delivery of drugs, today announced the enrollment of its first subject in a pivotal efficacy trial of its ZP-Triptan patch treatment for acute migraine. ZP-Triptan is a proprietary zolmitriptan-coated microneedle patch that is applied to a subject’s upper arm to deliver zolmitriptan during a migraine attack.
The pivotal efficacy study is a multicenter, randomized, placebo-controlled trial comparing three doses of ZP-Triptan (1.0 mg, 1.9 mg, and 3.8 mg) to placebo for the treatment of a single migraine attack. Three hundred and sixty subjects are expected to be enrolled at approximately 35 centers across the United States. Based on the Company’s discussions with the FDA and the FDA’s Oct 2014 Draft Guidance--"Migraine: Developing Drugs for Acute Treatment," the co-primary endpoints of this study are (i) pain freedom at 2 hours post dosing and (ii) freedom from each subject’s most bothersome symptom at 2 hours post-dosing.
"Commencing the pivotal efficacy trial for ZP-Triptan for migraine is a significant milestone as we transition the program to its anticipated final stage of development and reiterate that we expect to report pivotal efficacy data in 1Q2017," commented Konstantinos Alataris, Ph.D., Zosano’s President and Chief Executive Officer. "We believe the fast absorption kinetics of ZP-Triptan demonstrated in our Phase I trial have the potential to translate into rapid pain relief for migraine sufferers. If established, a rapid pain relief profile coupled with ZP-Triptan’s simple injection-free mode of delivery may provide migraine sufferers with an attractive treatment solution."
The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study, will be sufficient for approval under the 505(b)(2) pathway. The Company intends to complete the safety study after completion of the pivotal efficacy study.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma's microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma's microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.
This press release contains forward-looking statements regarding the timing of expected clinical development milestones, including the timeline for pivotal efficacy data, our ability to obtain necessary regulatory approvals 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 our 2015 Annual Report on Form 10-K, as filed with the Securities Exchange Commission on March 29, 2016. Although we believe 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.
Zosano Contact: Konstantinos Alataris, Ph.D. Chief Executive Officer 510-745-1200 Investor Contact: Patti Bank Westwicke Partners 415-513-1284 firstname.lastname@example.org
Source:ZP Opco, Inc.