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Zosano Pharma Files IND to Initiate a Phase 2/3 Clinical Study in Cluster Headache

1008 Days ago

FREMONT, Calif., Aug. 14, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 2/3 Clinical Trial for C213 in patients with Cluster Headache.

C213, for the treatment of cluster headache, consists of the company’s investigational proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM technology, which consists of titanium microneedles coated with drug, and is the same formulation as Qtrypta, for the acute treatment of migraine.

"There is a substantial need for new treatment options for people suffering from cluster headache, which produces an excruciating pain that has been described as one of the most severe types of pain known to medical science,” said Don Kellerman, Vice President of Clinical Development and Medical Affairs. “The challenge with treating this debilitating condition is that the attacks are relatively short-lasting and quick onset medications are required in order to provide meaningful benefit to patients. Based on the pharmacokinetic profile and onset of pain relief seen in our clinical trials with Qtrypta for Migraines, we believe C213 has the potential to be a transformational therapy for patients with cluster headaches.”

Pending regulatory review, Zosano intends to initiate the Phase 2/3 study, in which approximately 120 adults who suffer from chronic or episodic cluster headache will be randomized to receive 1.9 mg of C213, 3.8 mg of C213, or placebo in a 1:1:1 fashion. The co-primary endpoints of the study will be the proportion of patients who achieve pain relief at 15 minutes and the proportion of patients whose pain relief is sustained from 15 minutes to 60 minutes.

About Cluster Headache
Cluster headache is a debilitating neurological condition characterized by severe unilateral temporal and orbital pain. The excruciating headaches, lasting from 15 minutes to 3 hours and averaging 45 to 60 minutes, are often described by patients as the worst pain the patient has ever experienced, resulting in suicidal ideations in 15 to 22 percent of patients. Over 300,000 people in the United States suffer from cluster headaches.

About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of established molecules with established safety and efficacy profiles may provide an increased benefit to patients, for markets where patients remain underserved by existing therapies. The company’s Adhesive Dermally-Applied Microarray (ADAM) technology consists of titanium microneedles coated with drug that is designed to enable rapid systemic administration of therapeutics to patients. Zosano’s lead product candidate is QtryptaTM (M207), which is an investigational, proprietary formulation of zolmitriptan delivered via ADAM technology, currently in development for the acute treatment of migraine. In February 2017, the company announced positive and statistically significant results from the ZOTRIP pivotal study and in February 2019, the company announced the completion of the final milestone in its long-term safety study. The company is preparing to submit a New Drug Application to the Food and Drug Administration for Qtrypta (M207). Learn more at www.zosanopharma.com.

Forward-Looking Statements
This press release contains forward-looking statements regarding the potential activity of Qtrypta for treating cluster headache, the clinical trial of C213, the expected New Drug Application for Qtrypta 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 quarterly report on Form 10-Q. Although Zosano believes 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:
Greg Kitchener
Chief Financial Officer

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

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