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Zosano (ZSAN) Announces Completion Of Enrollment In Pivotal Efficacy Trial For M207 For Acute Migraine



11/8/2016 7:47:39 AM

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FREMONT, Calif., Nov. 08, 2016 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), an emerging CNS company focused on providing rapid symptom relief to patients using the Company's proprietary intracutaneous delivery system, today announced completion of enrollment in its registration-enabling, pivotal efficacy trial (the Zotrip trial), of M207 for the treatment of acute migraine.

“The completion of enrollment in the Zotrip study is a major milestone for the Company and bolsters our confidence in the previously announced availability of trial data in the first quarter of 2017,” commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. “The enrollment pace is also indicative of the urgent need for improved treatment options for those suffering with acute migraine.”

About the Zotrip Trial

The pivotal efficacy trial is a multicenter, double-blind, randomized, placebo-controlled trial comparing three doses of M207 (1.0 mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single migraine attack. Patients were recruited and enrolled in the Zotrip trial at 36 centers across the United States. Subjects recruited into the Zotrip trial had a history of at least one year of episodic, acute migraines with or without aura. Upon recruitment, the subjects enter a run-in period that ensures they meet the key eligibility criteria of 2-8 migraine attacks per month, which is documented using an electronic diary. Successfully screened subjects are then randomized into the treatment/dosing period in which they have 8 weeks to confirm and receive blinded treatment for a single migraine attack.

In regards to the Company’s discussions with the FDA and the FDA’s October 2014 Draft Guidance—“Migraine: Developing Drugs for Acute Treatment,” the co-primary endpoints of this study are:

  1. Pain freedom at 2 hours post-dosing, and
  2. Freedom from each subject’s most bothersome symptom at 2 hours post-dosing.

The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study, will be sufficient for approval under a 505(b)(2) pathway. The Company intends to conduct the safety study after completion of the Zotrip trial.

About M207

M207 is Zosano’s proprietary zolmitriptan-coated microneedle patch that is designed to rapidly deliver zolmitriptan during a migraine attack. In a phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company 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.

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 intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications.  The Company believes that its intracutaneous 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, sufficiency of our capital resources and need for future funding 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: Georgia Erbez Chief Business Officer, Interim CFO 510-745-1200 Investor Contact: Jamien Jones Blueprint Life Science Group 415-375-3340 x 5 jjones@bplifescience.com

Read at BioSpace.com


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