Zosano Reaches Enrollment Milestone in M207-ADAM Long-term Safety Study
March 16 2018 - 8:30AM
Zosano Pharma Corp. (NASDAQ:ZSAN) (“Zosano” or the “Company”) a
clinical stage biopharmaceutical company focused on providing rapid
systemic administration of therapeutics to subjects using its
proprietary Adhesive Dermally-Applied Microarray (“ADAM™”)
technology, today announced that the 100th patient has
enrolled and received M207 in the long-term safety study for the
acute treatment of migraine. M207 is Zosano’s lead
development candidate. M207-ADAM is an open label study
evaluating the safety of the 3.8mg dose of zolmitriptan in migraine
patients who have historically experienced at least 2 migraines per
month. Patients are expected to treat a minimum of two
migraines per month, with no maximum treatment limits. The
study will evaluate at least 150 patients for six months, and 50
patients for a year at 31 sites in the U.S. The Company may
elect to enroll more than the required number of patients to ensure
a robust data set, and achievement of the requisite number of
evaluable patients completing 6 and 12 months. The primary
objective of the study is to assess safety of M207 during repeated
use over 6 and 12 months. M207-ADAM study updates
include:
- 103 patients have qualified and received study drug
- additional 77 patients have signed consents and are in the
2-week run-in evaluation period
- study patients have treated 278 migraines since study
initiation
"Our clinical investigators are doing an excellent job in
patient recruitment and follow-up and we are pleased with the
study's progress," said Dr. Donald Kellerman, Zosano’s VP,
Clinical Development and Medical Affairs. "We have reached an
important milestone in our M207-ADAM study. With the 100th
patient enrolled, we project that 12 months from now, at least 50
of these patients will complete the study and have treated at least
two migraines per month. Our investigator partners will
continue enrolling to reach a sufficient number of patients such
that 150 patients will complete six months, but the clinical
completion of the study will occur after 50 subjects have completed
a year, which we estimate to be in one year.”
About M207
M207 is our proprietary formulation of zolmitriptan delivered
utilizing Zosano’s proprietary Adhesive Dermally-Applied
Microarray, or ADAM technology. Zosano’s ADAM technology
consists of titanium microprojections coated with drug, and in the
case of M207, our formulation of zolmitriptan. Our ADAM
technology delivers drug by penetrating the stratum corneum and
allowing drug to be absorbed into the microcapillary system of the
skin. In February 2017, the Company announced statistically
significant results from the ZOTRIP trial, which demonstrated that
the 3.8mg dose of M207 met both co-primary endpoints, achieving
pain freedom and most bothersome symptom freedom at 2
hours.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical
company focused on providing rapid systemic administration of
therapeutics to patients using our proprietary Adhesive
Dermally-Applied Microarray, or ADAM technology. The Company
recently announced positive results from our ZOTRIP study that
evaluated M207, which is our proprietary formulation of
zolmitriptan delivered via our ADAM technology, as an acute
treatment for migraine. Zosano is focused on developing
products where rapid administration of established molecules with
known safety and efficacy profiles provides an increased benefit to
patients, for markets where patients remain underserved by existing
therapies. The Company 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 the
Company's most recent annual report on Form 10-K.. 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 ErbezChief Business Officer and Chief
Financial Officer510-745-1200
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