Zosano Pharma Corp. (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, presented data from its pivotal Phase
2/3 ZOTRIP study evaluating M207 as an acute treatment for migraine
during the 18th Annual Congress of the International Headache
Society in Vancouver, BC. The data were presented by Dr. Don
Kellerman, Vice President of Clinical Development and Medical
Affairs.
As previously reported, the 3.8mg dose of M207 met both
co-primary endpoints of pain freedom and most bothersome symptom
freedom at 2 hours. In addition, the 3.8mg dose showed
durability of effect on pain freedom to 24 and 48 hours.
Two other poster presentations related to the results of the
ZOTRIP study were presented at the meeting. Dr. Pete Schmidt
and co-authors presented an abstract entitled “Experience with
Delayed Treatment of Migraine and Morning Migraine Treatment Using
Intracutaneous Zolmitriptan (M207).” Dr. David Dodick and
co-authors presented a poster based on an abstract entitled “Use of
Most Bothersome Symptom as an Endpoint in an Acute Treatment of
Migraine Trial.”
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.
“Presenting our results in a rigorous scientific forum, and
discussing them with world-class headache experts is very valuable
for helping us understand the types of patients who might benefit
most from our unique drug delivery method,” said Dr. Kellerman. “We
continue to receive positive input from experts in the field about
how this product could be valuable in the treatment paradigm for
migraine, once it is available for patients. We have been
fortunate to work with a great group of Clinical Advisors who
continue to provide valuable insight as we move forward with
clinical development.”
Zosano’s novel delivery of zolmitriptan was confirmed by the
results from the ZOTRIP study, where 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 effect 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.
The ZOTRIP Study
The ZOTRIP pivotal efficacy study 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. Subjects were enrolled in
the ZOTRIP trial at 36 centers across the United States. Those
recruited into the trial had a history of at least one year of
migraine episodes with or without aura. Upon recruitment, the
subjects entered a run-in period that ensured they met the key
eligibility criteria of 2-8 migraine attacks per month, which was
documented using an electronic diary or an app on their cell phone.
Subjects also identified their most bothersome symptom and
indicated the presence or absence of nausea, phonophobia or
photophobia, during the episodes in the run-in period. Successfully
screened subjects were then randomized into the treatment/dosing
period in which they had 8 weeks to confirm and receive blinded
treatment for a single migraine attack, termed "qualifying
migraine." In which the most bothersome symptom had to be
present.
During a qualifying migraine, subjects scored the severity of
pain on a 4-point scale, and the presence or absence of migraine
associated symptoms (photophobia, phonophobia or nausea), starting
pre-dose and then at several intervals over 48 hours post-dose.
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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