Zosano Pharma Initiates Phase 2/3 Clinical Study in Cluster Headache
“We are pleased to expand the application of our ADAM microneedle technology beyond our lead development indication for the acute treatment of migraine with this advanced stage clinical study in cluster headache,” said Dr.
Zosano has begun enrolling patients in its Phase 2/3 study, in which approximately 120 adults who suffer from 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 are 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 an under-recognized and often misdiagnosed, debilitating neurological condition characterized by severe unilateral temporal and orbital pain. These excruciating attacks can last from 15 minutes to 3 hours and can occur up to eight times a day, are often described by cluster patients as the worst pain they have ever experienced, resulting in suicidal ideations in 15 to 22 percent of patients. Over 300,000 people in
This press release contains forward-looking statements regarding the potential activity of C213 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.
Chief Financial Officer
Source: Zosano Pharma Corporation