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

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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.

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Globe Newswire: 14:00 GMT Wednesday 14th August 2019

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