Zosano Pharma Presents Early-Onset of Action Data for Qtrypta™ in Acute Treatment of Migraines
February 01 2021 - 8:30AM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that early onset of
action data for Qtrypta™, Zosano’s investigational therapy for the
acute treatment of migraine formulated utilizing its microneedle
system, were presented at the Annual Headache Cooperative of the
Pacific Winter Conference.
“We believe Qtrypta shows tremendous potential to become an
attractive therapeutic alternative to acutely treat migraines,”
said Steven Lo, President and CEO of Zosano. “As our lead program
utilizing our novel microneedle patch technology designed to
deliver drug through the skin, Qtrypta has demonstrated rapid pain
relief in patients who are often too nauseated to take oral
medications which take time to travel to the gastrointestinal tract
before providing pain relief.”
In a post-hoc retrospective analyses of data from the previously
published ZOTRIP trial involving 365 subjects who received Qtrypta
3.8 mg or placebo, of 82 Qtrypta-treated subjects, 38 reported pain
relief at 30 minutes, and 28 of the 38 subjects (74%) were pain
free at two hours. All 6 subjects treated with Qtrypta who reported
pain freedom at 30 minutes were pain-free at two hours. This
compares to nine of 26 subjects (35%) in the placebo group (n=77)
who reported pain relief at 30 minutes that were pain free at 2
hours, and 1 of 2 subjects that were pain free at 30 minutes being
pain free at 2 hours.
These data describe therapeutic gain at 30 minutes, a measure
consistent with recently published criteria for evaluating early
onset of action published in Cephalalgia, an International Journal
of Headache, by Pfelt-Hansen and Diener. The post-hoc analysis of
data from the ZOTRIP trial suggests that the therapeutic gain for
pain freedom, instead of pain relief, may be a more reliable
endpoint for evaluating early onset of action.
“Qtrypta demonstrated rapid and robust improvement in the rates
of pain relief and pain freedom in two hours. I believe that rapid
onset of meaningful and sustained improvement is of utmost
importance to patients suffering from migraines,” said Dr. Deborah
Friedman, Professor of Neurology and Ophthalmology at the
University of Texas Southwestern Medical Center.
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 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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