Zosano Pharma Announces Publication of Clinical Data Regarding the Long-term use of Qtrypta™ for the Treatment of Acute Mig...
May 26 2021 - 4:05PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that an article titled,
“Long Term Safety, Tolerability, and Efficacy of Intracutaneous
Zolmitriptan (M207) in the Acute Treatment of Migraine” was
published in The Journal of Headache and Pain. This open-label,
multicenter observational study was designed to evaluate the safety
and efficacy of the repeated use of Qtrypta™ in adults with
migraine who had historically experienced at least 2 migraine
attacks per month. The tolerability and efficacy results in this
long-term study were consistent with the results observed in the
Phase 2/3 ZOTRIP study.
“The data published provide safety and efficacy findings for
Qtyrpta™ when given repeatedly over the course of a year for
the acute treatment of migraine,” said Don Kellerman, PharmD, vice
president of clinical development and medical affairs of Zosano.
“The similarity of these findings with those from the pivotal
ZOTRIP study -- across primary and secondary outcome measurements
-- provide supportive evidence regarding the performance of
Qtrypta™, and if approved, its potential as a valuable long-term
treatment option for patients.”
Stephanie J. Nahas, MD, MSEd, FAHS, FAAN, Associate Professor of
Neurology at Thomas Jefferson University and Director of the
Headache Medicine Fellowship Program, added, “In this long-term
study, participants experienced on average about two migraine
attacks per month and achieved meaningful relief with Qtrypta
recurrently without serious side effects. If approved, I believe
Qtrypta™ may be welcomed by many patients who need a better
acute attack plan for their migraine.”
A total of 335 participants treated at least one migraine
attack, and in total 5,963 migraine attacks were treated over the
course of the study. The primary outcome measure was the percentage
of participants experiencing treatment emergent adverse events over
12 months. Secondary outcomes included the percentage of migraine
attacks for which pain freedom and most bothersome symptom freedom
were achieved at two hours post-dose, and the percentage for which
pain relief was achieved at two hours post-dose.
Participants achieved pain relief at two hours post-dose in 81%
of migraine attacks, pain freedom in 44% of attacks, and most
bothersome symptom freedom in 62% of attacks. The majority of
participants experienced cutaneous application site reactions where
the Qtrypta patch was applied, of which more than 95% were rated as
mild. More than 80% of swelling and redness incidents were resolved
(rated as zero) by 48 hours following application.
About Qtrypta™ (M207)Qtrypta is Zosano’s
proprietary investigational formulation of zolmitriptan delivered
utilizing its proprietary transdermal microneedle system (the
“System”) in development for the acute treatment of
migraine. The System consists of titanium microneedles coated
with drug, and in the case of Qtrypta™, the formulation is
zolmitriptan. The drug-coated microneedles are designed to
penetrate the stratum corneum, where the investigational drug
potentially dissolves and easily enters into the bloodstream.
In February 2017, the company announced statistically
significant results from the ZOTRIP pivotal study, in which the 3.8
mg dose of Qtrypta™ met both co-primary endpoints, achieving pain
freedom and most bothersome symptom freedom at 2 hours.
About MigraineMigraine is a highly prevalent
neurological disease impacting 12% of the US population and 1 in 4
households. Patients impacted by migraine experience significant
disability, with 90% unable to function normally. Migraine
attacks are estimated to lead to lost productivity costs as high
as $36 billion annually in the United States,
including both direct and indirect costs. Zosano believes there is
a significant need for new acute treatment options since 74% of
migraine patients experience inadequate treatment response.
About Zosano PharmaZosano Pharma Corporation is
a clinical-stage biopharmaceutical company focused on developing
products where rapid administration of approved molecules with
established safety and efficacy profiles may provide substantial
benefit to patients, in markets where patients remain underserved
by existing therapies. The company’s transdermal microneedle system
technology consists of titanium microneedles coated with drug that
are designed to enable rapid systemic administration of
therapeutics to patients. Zosano’s lead product candidate is
Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan
designed to be delivered via its transdermal microneedle system
technology, as an acute treatment for migraine. Learn more at
www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, the potential benefits and availability of Qtrypta
for patients and other future events and expectations described in
this press release. 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 risks and uncertainties,
without limitation, associated with the company’s ability to obtain
additional cash resources to continue operations, 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 and quarterly
reports on Form 10-Q. Although Zosano believes that the
expectations reflected in these forward-looking statements are
reasonable, Zosano 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 Contacts:Christine MatthewsChief
Financial Officer510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
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