Late-Breaking Oral and Oral Presentations to feature M207 Acute Migraine Therapy
Zotrip Pivotal Trial Data Selected by Headache Society and Drug Delivery Meetings
FREMONT, Calif., June 01, 2017 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a specialty pharmaceutical company that recently established a differentiated safety and efficacy profile in a pivotal trial with its lead product, M207, as an acute treatment for migraine, today announced that three conferences have accepted Zosano submissions for oral presentation at their annual meetings. Zosano will have a late-breaking oral presentation at the American Headache Society meeting in June, as well as an oral presentation at the International Headache Society meeting in September. In addition, Zosano has been selected to present at the Transdermal and Intradermal Drug Delivery Systems conference, also in September.
“The selection of our data for oral presentations at these key medical meetings underscores the need for new therapies for migraine patients,” said Don Kellerman, Vice President of Clinical Development and Medical Affairs at Zosano. “We believe that it is important to increase awareness of M207 and its compelling clinical results among key opinion leaders as well as community physicians.”
“The clearly differentiating data from our Zotrip trial highlights the potential of our lead migraine product as well as the underlying technology that has made its clinical results possible,” said John Walker, Zosano’s Interim CEO and Chairman of the Board of Directors. “These presentations offer a forum to present M207 as a primary treatment option, if approved, for acute migraine sufferers who seek a therapeutic option that is both fast acting at onset and offers a durable response.”
Below is a schedule for the oral presentations:
| Conference: | American Headache Society (AHS) 59th Annual Scientific Meeting |
| Presentation Title: | “Effectiveness and Safety of a New Zolmitriptan Rapid Absorption Microneedle Array (M207) for the Acute Treatment of Migraine (The Zotrip Study)” |
| Date: | Saturday, June 10, 10:00 AM |
| Location: | Boston, MA, Westin Boston Waterfront |
| Abstract: | IOR13LB |
| Conference: | 18th Congress of the International Headache Society |
| Title: | “Comparative Effects of 3 Doses of Zolmitriptan Patch (M207) and Placebo on Pain and Most Bothersome Symptom for the Acute Treatment of Migraine: The Zotrip Study” |
| Date: | September 9, 2017, 11 AM |
| Location: | Vancouver, Canada, Vancouver Convention Center |
| Abstract: | IHC2017-157 |
| Conference: | Transdermal and Intradermal Drug Delivery Systems 2017 |
| Title: | Clinical Trial Experience with the Intracutaneous Microneedle Systems: Experience in Osteoporosis, Diabetes, and Migraine |
| Sponsor: | PharmaEd Resources Inc. |
| Date: | September 28, at 1:15pm |
| Location: | Philadelphia, PA, Racquet Club of Philadelphia |
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 coated onto our patented intracutaneous microneedle patch, which is then applied with our proprietary applicator to ensure uniform and consistent application. 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. In a Phase 1 trial, M207 demonstrated markedly faster absorption kinetics compared to oral zolmitriptan. The Company presented these results at the 2016 annual meeting of the American Headache Society.
About Zosano Pharma
Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company's proprietary intracutaneous delivery system. The Company's goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications. The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma 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.