Zosano to Present Additional Analyses from the ZOTRIP Pivotal Study on Pain Relief and Recurrence at the 2018 American Headache Society (AHS) Meeting
Key findings on receptor and binding kinetics also to be presented in a poster and oral presentation
FREMONT, Calif., June 27, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma, a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies that deliver rapid systemic absorption using a novel and proprietary technology called Adhesive Dermally-Applied Microarray (“ADAM™”) with the potential to transform patient lives and advance patient care, announced additional analyses from the Phase 2/3 clinical study on pain relief by time and recurrence of migraine in subjects with pain relief at two hours will be presented at the American Headache Society Meeting. A poster and oral presentation on receptor and binding kinetics will also be presented during the 60th Annual Scientific Meeting to be held on June 28 – July 1, 2018 in San Francisco, CA.
“The combination of fast onset of pain relief and low headache recurrence from a migraine attack treatment has rarely, if ever, been reported in previous triptan trials. Generally, triptans that have had a fast onset of pain relief have had a high headache recurrence rate, making their use less than optimal,” said lead presenter Alan M. Rapoport, M.D., professor of Neurology at the David Geffen School of Medicine at UCLA. “Furthermore, Dr. Graeme Martin, the creator of zolmitriptan, and colleagues present novel data on the receptor occupancy of zolmitriptan and sumatriptan.”
As previously announced, the ZOTRIP Phase 2/3 clinical study of ADAM™ zolmitriptan for the acute treatment of migraine achieved statistically significant and clinically meaningful results of primary endpoints which included 41.5% pain freedom at two hours compared to placebo and 68.3% relief of most bother symptom at two hours compared to placebo. 81% of subjects achieved pain relief at two hours and was sustained through 24 hours. The most commonly reported adverse events were application site erythema which generally resolved within 48 hours and bruising. In November 2017, the Company announced the initiation of its long-term safety study evaluating ADAM™ zolmitriptan and expects to file an NDA for M207 in the fourth quarter of 2019.
PF50: Rapid Systemic Absorption of Zolmitriptan from M207 is Associated with a High Rate of Pain Relief and a Low Incidence of Moderate or Severe Pain Recurrence
Presenter: Alan M. Rapoport, MD
Friday, June 29th | 1:15pm – 2:15pm
PS80: Analysis of Ligand-Receptor Kinetics of Zolmitriptan, its Primary Metabolite, and Sumatriptan
Presenter: Graeme R. Martin, PhD
Saturday, June 30th | 1:00pm - 2:15pm
Oral Presentation: Binding Kinetics of Zolmitriptan, N-desmethyl-zolmitriptan and Sumatriptan
Presenter: Graeme R. Martin, PhD
Saturday, June 30th | 1:25pm – 1:30pm
M207 is our proprietary formulation of zolmitriptan delivered utilizing Zosano's proprietary 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 pivotal study, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at two hours. In November 2017, the Company announced the initiation of its long-term safety study evaluating M207 and expects to file an NDA for M207 in the fourth quarter of 2019.
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.
Chief Executive Officer and Chairman of the Board
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