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Jun 13, 2020

Zosano Pharma to showcase new post-hoc analyses of Qtrypta’s (M207) clinical trial data comparing key efficacy results from the pivotal study and the open-label long term safety study on the 2020 American Headache Society’s Virtual Annual Scientific Meeting Platform

FREMONT, Calif., June 13, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that new post-hoc efficacy analyses of QtryptaTM, Zosano’s lead investigational product candidate for the acute treatment of migraine, will be presented as a virtual oral presentation on the 2020 American Headache Society’s Virtual Annual Scientific Meeting Platform.

Six different measurements of pain reduction from the exploratory efficacy results in the long-term safety study (“LTSS”) were examined and compared to the positive clinical results observed in the Phase 2/3 Zotrip study.  Across all six efficacy measurements, which included pain freedom and pain relief at 2 hours, clinical activity observed in the LTSS during the one-year trial period treating approximately 6,000 attacks was consistent with the positive pivotal study results.

Parameter ZOTRIP (Single Dose) Open-Label
Placebo M207 3.8 mg M207 3.8 mg
(n = 77) (n = 82) (5,617 migraine attacks*)
Pain Freedom at 2 hours 14% 42% 44%
Pain Relief at 2 hours 57% 81% 81%
Sustained Pain Freedom 2-24 hour 10% 32% 38%
Sustained Pain Freedom 2-48 hour 9% 27% 35%
Sustained Pain Relief 2-24 hour 38% 68% 70%
Sustained Pain Relief 2-48 hour 33% 63% 65%
* For sustained endpoints, data from all timepoints 2-24 (48) hours had to be present

Similar to the pivotal study, the most common adverse events observed in the LTSS were redness and swelling at the application site, of which more than 95% were classified as mild. 80% of these site reactions were generally resolved within 48 hours. Patients treated with Qtrypta reported less triptan-like neurological side effects than are typically found with the class, with less than 2% of patients in the LTSS reporting effects such as dizziness and paresthesia.

“Migraine is a painful and debilitating neurologic disease impacting over 34 million people in the US. The post-hoc analyses suggest that Qtrypta’s efficacy results across approximately 6000 attacks treated in the LTSS were consistent with the positive results seen in the pivotal Zotrip study,“ said Egilius Spierings, MD, Founder, Medical Director, and Principal Investigator Medvadis Research Director, Boston Headache Institute at Boston PainCare. “I believe that Qtrypta, if approved, has the potential to be a promising and innovative option for migraine patients.”

“As we continue to learn about the profile of our unique investigational product being developed as a potential treatment for headache disorders, we remain committed to sharing this information with the scientific community,” said Dr. Don Kellerman, Vice President of Clinical Development and Medical Affairs at Zosano.

About Qtrypta™ (M207)

Qtrypta is Zosano’s proprietary formulation of zolmitriptan delivered utilizing its proprietary intracutaneous microneedle system (the “System”) in development for the acute treatment of migraine.   The System consists of titanium microneedles coated with drug, and in the case of Qtrypta™, the formulation is zolmitriptan. The drug-coated microneedles are designed to penetrate the stratum corneum, where the investigational drug dissolves and easily enters into the bloodstream. In February 2017, the Company announced statistically significant results from the ZOTRIP pivotal study, in which the 3.8 mg dose of Qtrypta™ met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours.

About Migraine

Migraine is a highly prevalent neurological disease impacting 12% of the US population and 1 in 4 households. Patients impacted by migraine experience significant disability, with 90% unable to function normally.  Migraine attacks are estimated to lead to lost productivity costs as high as $36 billion annually in the United States, including both direct and indirect costs. There is a significant need for new acute treatment options since 74% of migraine patients experience inadequate treatment response.

About Zosano Pharma

Zosano Pharma Corporation is a clinical-stage biopharmaceutical company focused on developing products where rapid administration of approved molecules with established safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s intracutaneous microneedle system technology consists of titanium microneedles coated with drug that are designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan delivered via its intracutaneous microneedle system technology, as an acute treatment for migraine. The company anticipates that many of its current and future development programs may enable the company to utilize a regulatory pathway that has the potential to streamline clinical development and accelerate the path towards commercialization.

Forward-Looking Statements

This press release contains forward-looking statements regarding the presentation of post-hoc analyses of Qtrypta’s (M207) clinical trial data on the 2020 American Headache Society’s Virtual Annual Scientific Meeting Platform, the potential benefits of Qtrypta for patients and other future events and expectations described in this press release. 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 Company’s ability to obtain additional cash resources to continue operations for the remainder of 2020, 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 and quarterly reports on Form 10-Q. Although Zosano believes that the expectations reflected in these forward-looking statements are reasonable, Zosano 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:
Christine Matthews
Chief Financial Officer
(510) 745-1200

PR Contacts:
Sylvia Wheeler or Alexandra Santos
swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com


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Source: Zosano Pharma Corporation