First Subject Treated in Zosano Pharma’s Pivotal Efficacy Trial for M207 Patch for Acute Migraine
25 7월 2016 - 9:30PM
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October 2014 Draft Guidance--"Migraine: Developing Drugs for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
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