FREMONT, Calif., July 25, 2016 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ: ZSAN ), an emerging CNS company focusing on providing rapid symptom relief to patients using the Company’s proprietary transdermal delivery system, today announced the dosing of its first subject in its registration-enabling pivotal efficacy trial (the Zotrip trial), of its M207 patch, formerly known as ZP-Triptan, for the treatment of acute migraine.
“I’m extremely pleased to announce our first subject treated in the Zotrip trial. We are pleased with enrollment to date and reiterate that trial results are expected to be reported in the first quarter of 2017,” commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. To date, 136 subjects have enrolled in the trial, 109 of which are in the run-in phase, and 7 subjects have been randomized.
M207 is Zosano’s proprietary zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan during a migraine attack. In a recently completed phase I trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company recently presented these results at the 2016 annual meeting of the American Headache Society. The Company believes M207’s injection-free mode of delivery has the potential to provide an attractive solution for acute migraine sufferers.
The ongoing Zotrip trial is a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0 mg, 1.9 mg, and 3.8 mg) to placebo for the treatment of a single migraine attack. Three hundred sixty subjects are expected to be treated in the Zotrip trial at approximately 35 centers across the United States. Subjects are recruited into the Zotrip trial if they have a history of at least one year of episodic, acute migraines with or without aura. Upon recruitment, subjects undergo a screening and run-in period to ensure they meet the key eligibility criterion of 2-8 migraine attacks per month, documented using an electronic diary. Successfully screened subjects are then randomized into the treatment/dosing period and have 8 weeks to confirm and receive blinded treatment for a single migraine attack. Today’s announcement marks the commencement of the dosing/treatment phase of the Zotrip trial.
Based on the Company's discussions with the FDA and the FDA's October 2014 Draft Guidance--" Migraine: Developing Drugs for Acute Treatment ," the co-primary endpoints of this study are: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.
Furthermore, 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 conduct the safety study after completion of the Zotrip trial.
About Zosano Pharma
Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary transdermal delivery system. The Company’s goal is to make transdermal drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary transdermal delivery system to administer novel formulations of existing drugs through the skin for the treatment of a variety of indications. The Company believes that its transdermal delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization. Learn more at www.zosanopharma.com .
Forward-Looking Statements
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 "expects," "continues," "believes," "potential," “goal,” "may," "will," "would," "could," "should," "might," "estimates," "projects," "plans," "anticipates," "intends," "forecast," "designed," "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: Jamien Jones Blueprint Life Science Group 415-375-3340 x 5 jjones@bplifescience.com OR Patti Bank Westwicke Partners 415-513-1284 patti.bank@westwicke.com
