Zosano Announces the Publication of an Analysis of Acute Treatments for Migraine in Headache: The Journal of Head and Face Pa...
16 4월 2019 - 9:30PM
Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the
“Company”), a clinical-stage biopharmaceutical company, today
announced the peer-reviewed publication of a review and analysis of
recently-completed trials using newly FDA-recommended endpoints in
the acute treatment of migraine. The review article, led by
Stanford Assistant Professor of Neurology, Nada Hindiyeh, MD., was
published in Headache, titled “Review of Acute Treatment of
Migraine Trial Results With the New FDA Endpoints: Design
Implications for Future Trials.”
In this analysis, researchers reviewed eight published trials
designed in accordance with the Guidance for Industry, “Migraine:
Developing Drugs for Acute Treatment”, finalized in February 2018,
that recommended using co-primary endpoints of pain freedom and
freedom from most bothersome symptom (MBS) at 2-hours
post-treatment. Using the placebo response rates from these various
trials, the authors were able to calculate required sample sizes
for future trials and compare these calculations to the sample
sizes actually used in completed trials. Included in this analysis
was Zosano’s ZOTRIP trial, in which 41.5% of subjects in the
QTRYPTA 3.8mg arm achieved pain freedom at two hours and 68.3%
achieved freedom from their MBS at two hours, as compared to 14.3%
and 42.9% respectively in the placebo group. Furthermore, the
analysis showed that the average response rates across all active
groups of these trials were 30.4% for pain freedom and 46.7% for
MBS freedom, compared to 16.8% and 33% respectively for the placebo
groups. Using these averages, future trials would need to enroll
approximately 180 subjects per arm to demonstrate statistical
significance with 80% power. Researchers noted that the majority of
the completed trials enrolled far more than this, with subjects per
group reaching as high as 751.
“It’s an exciting time in migraine treatment with so many acute
treatments on the horizon,” said Dr. Hindiyeh, lead author on the
manuscript. “These data may help to guide future migraine
researchers in the design of migraine trials, and clinicians in
interpreting these new endpoints on drug labels.”
About Qtrypta (M207)Qtrypta is Zosano’s
proprietary formulation of zolmitriptan delivered utilizing its
proprietary ADAM technology. Zosano's ADAM technology consists of
titanium microneedles coated with drug, and in the case of Qtrypta,
its formulation of zolmitriptan. The drug-coated microneedles
penetrate into the epidermis and dermis, where the investigational
drug is dissolved and enters into the bloodstream. In February
2017, the Company announced statistically significant results from
the ZOTRIP pivotal study, in which the 3.8mg dose of Qtrypta met
both co-primary endpoints, achieving pain freedom and most
bothersome symptom freedom at 2 hours. In November 2017, the
Company announced the initiation of its long-term safety study
evaluating Qtrypta and expects to file an NDA for Qtrypta in the
fourth quarter of 2019.
Forward-Looking StatementsThis press release
contains forward-looking statements regarding the expected timing
of an NDA 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," "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, without limitation, risks and uncertainties
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 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 Contact:Sylvia Wheeler and Alexandra
Santosswheeler@wheelhouselsa.com/asantos@wheelhouselsa.com
Zosano Pharma (NASDAQ:ZSAN)
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