Zosano Pharma Announces Last Subject Treated in its Migraine Pivotal Trial
January 05 2017 - 8:30AM
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.
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
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