- Peer-reviewed article published in Journal of Pharmaceutical Science evaluates skin tolerability and bioavailability of ADAM’s intracutaneous zolmitriptan delivery
FREMONT, Calif., July 17, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma (NASDAQ:ZSAN), 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, today announced the recent publication of a peer-reviewed paper regarding ADAM technology for the delivery of zolmitriptan in the Journal of Pharmaceutical Science.
“This study enabled us to understand the delivery and tolerability of M207 in a nonclinical setting so as to aid us in setting reasonable expectations of our platform when studying in human subjects,” said Hayley Lewis, senior vice president, operations at Zosano Pharma. “The results from this animal study add to a growing body of evidence which indicate that absorption through the epidermis or dermis seems to be a suitable delivery platform for products that have limitations when delivered orally.”
In vivo studies were conducted in pigs using ADAM 1.9-mg zolmitriptan. Pharmacokinetic studies showed that the ADAM 1.9-mg zolmitriptan was delivered with high efficiency (85%) and high absolute bioavailability (77%). Furthermore, in vivo evaluation showed a rapid systemic absorption with a median Tmax of 15 min. These results provided validation to advance the development of ADAM zolmitriptan.
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. The drug-coated microneedles physically break through the stratum corneum and penetrate into the epidermis and dermis, where the dry drug coating is dissolved by the surrounding skin interstitial fluid. 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 2 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.
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