Zosano Pharma Announces Outcome of End of Phase 2 Meetings with FDA
June 26 2017 - 8:30AM
Zosano Pharma Inc. (NASDAQ:ZSAN) (“Zosano” or the “Company”) a
clinical stage biopharmaceutical company focused on providing rapid
systemic administration of therapeutics to patients using our
proprietary ADAM technology, today announced receipt of final
minutes from recent End of Phase 2 meetings with the U.S. Food and
Drug Administration (FDA). The focus of this meeting was to
confirm three key elements to the continued development of Zosano’s
lead program, M207 as an acute treatment for migraine:
- Confirmation of a single, positive Efficacy Study Sufficient
for NDA filing – Zosano received confirmation that a single
efficacy study, our recently completed ZOTRIP trial, is sufficient
to support an NDA filing for M207. Final determination of
whether sufficient efficacy has been achieved remains subject to an
NDA submission and formal FDA review of the data from the ZOTRIP
trial.
- Design of Long-term Safety Study – FDA confirmed the previously
announced design of the Long-term Safety Study as sufficient to
support an NDA filing for M207. The trial will evaluate the
safety of repeat dosing of M207 in migraine patients, evaluating
150 patients to six months and 50 patients to a year. It is
anticipated that patients will use M207 a minimum of twice per
month. The primary emphasis will be on confirming skin
tolerability during a year of dosing.
- Chemistry, Manufacturing and Controls – In a separate,
concurrent communication, Zosano presented its proposed CMC
development plan to the FDA. The FDA concurred that the
development strategy, which conforms to relevant regulatory
guidelines, appears adequate for registration of M207. CMC
approval remains subject to NDA submission and FDA formal review
and successful site inspections.
“We are pleased with the collaborative end-of-Phase 2 meetings
with FDA that enabled us to receive detailed guidance regarding the
further development of M207 and advancing towards an NDA filing,”
said Don Kellerman, Zosano’s Vice President, Clinical Development
and Medical Affairs. “This meeting represents the completion
of another important milestone for M207, and we look forward to
initiating our Long-term Safety Study in the third quarter of 2017,
as previously announced.”
M207 is designed to rapidly deliver zolmitriptan during a
migraine attack 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 zolmitriptan by
abrading the stratum corneum and allowing drug to be absorbed into
the microcapillary system of the skin.
As previously reported, the 3.8mg dose of M207 achieved both
co-primary endpoints of pain freedom and most bothersome symptom
freedom at 2 hours. In addition, the 3.8mg dose achieved
significance in the secondary endpoints of pain freedom at 45
minutes and 1 hour and showed durability of effect on pain freedom
at 24 and 48 hours. 41.5% of the patients treated with the
3.8mg dose of M207 achieved pain freedom at 2 hours, and the effect
also appeared to be durable, with 31.7% and 26.8% of patients
achieving sustained pain freedom from 2-24 hours and 2-48 hours,
respectively. In post-hoc analyses, M207 also demonstrated efficacy
in traditionally difficult to treat established migraine headaches,
as evidenced by a nearly identical therapeutic gain in those who
treated prior to and after 2 hours. Additionally, 44% of patients
who awoke with their migraine headache were pain free at 2 hours.
Patients in this trial were instructed not to treat until their
headache reached moderate to severe intensity, and the mean time
from headache onset to treatment was almost 5 hours. M207 was
well-tolerated with no SAEs. Overall, 13 subjects (3.9%)
reported pain at the application site; application site pain was
reported as mild in all but 3 subjects. The most frequently
reported adverse event was redness at the application site (18.3%
of subjects). All cases of redness resolved.
Additionally, 5 (1.5%) patients across M207-treated groups reported
dizziness vs 0% on placebo.
About Migraine
Migraine is the leading cause of disability among neurological
disorders in the United States according to the American Migraine
Foundation. Migraine symptoms can include moderate to severe
headache pain combined with nausea and vomiting, or abnormal
sensitivity to light and sound. According to the Migraine
Research Foundation, migraine affects 30 million men, women
and children in the United States. Most migraines last between four
and 24 hours, but some last as long as three days. According to
published studies, 63% of migraine patients experience between one
and four migraines per month. According to Decision Resources,
prescription drug sales for migraine in the top seven countries
were estimated to be $3.3 billion in 2015, and are expected to grow
to $4.4 billion in 2020. Triptans, a family of tryptamine-based
drugs first sold in the 1990s, account for almost 75% of
anti-migraine therapies prescribed at office visits.
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 abrading 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:
John Walker
Interim Chief Executive Officer
510-745-1200
Investor Contact:
Jamien Jones
Blueprint Life Science Group
415-375-3340 x 5
jjones@bplifescience.com
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