Zosano Pharma Announces Last Subject Treated in its Migraine Pivotal Trial
FREMONT, Calif., Jan. 05, 2017 (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 that the last subject has been treated in the Company's registration-enabling, pivotal efficacy trial (the Zotrip trial), of M207 for the treatment of migraine.
"Having reached this milestone for the Zotrip study reinforces our expectation that top-line data will be reported in the first quarter of 2017 as planned," commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. "On behalf of the entire management team, I would like to extend our sincere appreciation to Zotrip's investigators and study participants for their shared commitment to finding improved treatment options for those suffering with migraine."
The Zotrip 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. Subjects were 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 migraine episodes with or without aura. Upon recruitment, the subjects entered a run-in period that ensured they met the key eligibility criteria of 2-8 migraine attacks per month, which was documented using an electronic diary. Successfully screened subjects were then randomized into the treatment/dosing period in which they had 8 weeks to confirm and receive blinded treatment for a single migraine attack.
The co-primary endpoints of this study are:
- proportion of subjects with pain freedom at 2 hours post-dosing, and
- proportion of subjects with freedom from their most bothersome symptom at 2 hours post-dosing. These symptoms include photophobia, phonophobia or nausea, pre-specified by each subject.
A key secondary endpoint of this trial is pain relief at 30 min, aimed at demonstrating the rapid relief profile of M207.
These endpoints were chosen after the Company's discussions with the Food and Drug Administration (FDA), and meet all criteria set forth by the FDA's October 2014 Guidance Document —"Migraine: Developing Drugs for Acute Treatment."
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.
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.
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 firstname.lastname@example.org