Zosano Pharma Corp. (NASDAQ:ZSAN) (“Zosano” or the “Company”) a
clinical stage biopharmaceutical company focused on providing rapid
systemic administration of therapeutics to subjects using its
proprietary Adhesive Dermally-Applied Microarray (“ADAM”)
technology, announced today that Cephalalgia had published the
Company’s positive results from our pivotal, multi-center, double
blind, placebo controlled, trial demonstrating efficacy and safety
of M207, our formulation of zolmitriptan using our ADAM technology.
ADAM is Zosano Pharma’s proprietary, investigational technology
platform designed to offer rapid drug absorption into the
bloodstream, which can result in an improved pharmacokinetic
profile compared to original dosage forms. ADAM consists of an
array of drug-coated titanium microprojections mounted on an
adhesive backing that is pressed on to the skin using a reusable
handheld applicator. The microprojections penetrate the
stratum corneum and allow drug to be absorbed into the
microcapillary system of the blood.
Cephalalgia published a paper titled “Randomized, Double-blind,
Placebo-controlled, Parallel-group, Multi-center Study of the
Safety and Efficacy of ADAM Zolmitriptan for the Acute Treatment of
Migraine”, which contained the positive results from Zosano’s
ZOTRIP pivotal study. ZOTRIP was a multicenter, double-blind,
randomized, placebo-controlled trial comparing three doses of M207
(1.0mg, 1.9mg, and 3.8mg) to placebo for the treatment of a single
migraine attack. In this study of 365 migraineurs, the 3.8mg
dose of M207 demonstrated a statistically significant benefit in
both freedom from pain and freedom from a patient’s most bothersome
symptom (photophobia, phonophobia or nausea and vomiting) at the 2
hour pre-specified primary endpoint. Secondary endpoints
demonstrated pain freedom at 45 min after administration, with an
effect that was sustainable for 48 hours post treatment. The
majority of adverse events were mild or moderate application site
reactions. There were no serious adverse events. Zosano announced
the results of the ZOTRIP trial in February 2017.
“We are grateful for the contributions of our investigators,
co-authors and advisors on the design, execution, analysis and
reporting of the ZOTRIP trial,” said Dr. Don Kellerman, Vice
President of Clinical Development. “We believe that the time
from topline results to peer-reviewed publication in a prestigious
journal reflects the design of the study and the unambiguous
results.”
"We are pleased to have the results of ZOTRIP, our pivotal
study, published in Cephalalgia," stated John P. Walker, Zosano’s
Chairman and Chief Executive Officer. "The recognition of the
results from ZOTRIP in such a well-known journal will continue to
raise awareness of M207, and its ability to address an unmet need
for patients struggling to find rapid and durable pain relief for
migraine episodes.”
ZOTRIP Results
Five hundred and eighty nine subjects were enrolled in this
study, of which 365 were randomized. Of those randomized, 333
subjects treated and are included in the safety analysis, and 321
qualified for the modified intent-to-treat (mITT) population. 51%
of the subjects randomized were found to have severe migraine pain
pre-treatment. Also at the time of treatment, 70% reported nausea,
37% aura, and 51% waking up with their migraine (morning
migraine). With the multiple doses and multiple endpoints in
the trial, a sequential testing procedure was used beginning with
the highest dose and the co-primary endpoints. Since
statistical significance was not achieved for most bothersome
symptom in the 1.9 mg group, p-values for secondary endpoints
should be considered nominal p-values.
The 3.8mg dose of M207 achieved statistical significance for
both co-primary endpoints at two hours:
Primary endpoint |
Placebo |
3.8mg M207 |
p-value |
Pain freedom |
14.3 |
% |
41.5 |
% |
0.0001 |
Most bothersome symptom free |
42.9 |
% |
68.3 |
% |
0.0009 |
|
|
|
|
|
|
Furthermore, secondary endpoints measuring pain freedom at
additional time points for the 3.8mg dose of M207 showed M207
superior to placebo with a nominal p-value less than 0.05:
Pain Freedom |
Placebo |
3.8mg M207 |
p-value |
Pain freedom at 45 minutes |
5.2 |
% |
17.1 |
% |
0.0175 |
Pain freedom at 60 minutes |
10.4 |
% |
26.8 |
% |
0.0084 |
Pain freedom at 24 hours |
39.0 |
% |
69.5 |
% |
0.0001 |
Pain freedom at 48 hours |
39.0 |
% |
64.6 |
% |
0.0013 |
|
|
|
|
|
|
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:Georgia ErbezChief Business
Officer and Chief Financial Officer510-745-1200
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