Zosano Pharma Initiates Phase 2/3 Clinical Study in Cluster Headache
24 Oktober 2019 - 3:00PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that the company has
begun enrolling cluster headache patients in the ATAC clinical
trial. This Phase 2/3 study will evaluate the efficacy of C213 for
the acute treatment of cluster headache. C213 is the company’s
investigational proprietary formulation of zolmitriptan delivered
utilizing its proprietary ADAM patch technology, which consists of
titanium micro-projections coated with drug and is the same
formulation as QtryptaTM, for the acute treatment of migraine.
“We are pleased to expand the application of our ADAM
microneedle technology beyond our lead development indication for
the acute treatment of migraine with this advanced stage clinical
study in cluster headache,” said Dr. Don Kellerman, Vice President
of Clinical Development and Medical Affairs. “This population
suffers from excruciating and debilitating pain and has limited
effective treatment options with no new FDA-approved drugs for the
acute treatment of cluster headache since the 1990s. We are excited
that the clinically significant pain freedom and relief observed in
our migraine trial will potentially also be demonstrated in the
cluster headache clinical trial.”
Bob Wold, founder of Clusterbusters and a person who suffers
from cluster headaches added, “We applaud Zosano’s focus on
developing a new acute treatment option for patients who experience
the deep and relentless pain associated with cluster headache. I
believe Zosano’s C213 drug candidate represents a patient-friendly
therapeutic patch that has potential to rapidly and significantly
reduce cluster headache pain over a sustained period. If proven
successful in this late stage trial, C213 could be a very
attractive therapeutic option for our community.”
Zosano has begun enrolling patients in its Phase 2/3 study, in
which approximately 120 adults who suffer from cluster headache
will be randomized to receive 1.9 mg of C213, 3.8 mg of C213, or
placebo in a 1:1:1 fashion. The co-primary endpoints of the study
are the proportion of patients who achieve pain relief at 15
minutes and the proportion of patients whose pain relief is
sustained from 15 minutes to 60 minutes.
About Cluster Headache Cluster headache is an
under-recognized and often misdiagnosed, debilitating neurological
condition characterized by severe unilateral temporal and orbital
pain. These excruciating attacks can last from 15 minutes to 3
hours and can occur up to eight times a day, are often described by
cluster patients as the worst pain they have ever experienced,
resulting in suicidal ideations in 15 to 22 percent of patients.
Over 300,000 people in the United States suffer from cluster
headache.
About Zosano PharmaZosano Pharma Corporation is
a clinical stage biopharmaceutical company focused on developing
products where rapid administration of molecules with demonstrated
safety and efficacy profiles may provide substantial benefit to
patients, in markets where patients remain underserved by existing
therapies. The company’s Adhesive Dermally-Applied Microarray
(ADAM) technology consists of titanium micro-projections coated
with drug that is designed to enable rapid systemic administration
of therapeutics to patients. Zosano’s lead product candidate is
QtryptaTM (M207), which is an investigational, proprietary
formulation of zolmitriptan delivered via ADAM technology,
currently in development for the acute treatment of migraine. In
February 2017, the company announced positive and statistically
significant results from the ZOTRIP pivotal study, and in February
2019, the company announced the completion of the final milestone
in its long-term safety study. The company is preparing to submit a
New Drug Application to the Food and Drug Administration for
Qtrypta (M207). Learn more at www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements regarding the potential
activity of C213 for treating cluster headache, the clinical trial
of C213, the expected New Drug Application for Qtrypta 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 quarterly report on Form 10-Q. Although
Zosano believes 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:Greg KitchenerChief Financial
Officer 510-745-1200
PR Contacts:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or
asantos@wheelhouselsa.com
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