Zosano Pharma Initiates Phase 2/3 Clinical Study in Cluster HeadacheAdvances Second Late Stage Program for ADAM Microneedle Technology
FREMONT, Calif., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the company has begun enrolling cluster headache patients in the ATAC clinical trial. This Phase 2/3 study will evaluate the efficacy of C213 for the acute treatment of cluster headache. C213 is the company’s investigational proprietary formulation of zolmitriptan delivered utilizing its proprietary ADAM patch technology, which consists of titanium micro-projections coated with drug and is the same formulation as QtryptaTM, for the acute treatment of migraine.
“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. Don Kellerman, Vice President of Clinical Development and Medical Affairs. “This population suffers from excruciating and debilitating pain and has limited effective treatment options with no new FDA-approved drugs for the acute treatment of cluster headache since the 1990s. We are excited that the clinically significant pain freedom and relief observed in our migraine trial will potentially also be demonstrated in the cluster headache clinical trial.”
Bob Wold, founder of Clusterbusters and a person who suffers from cluster headaches added, “We applaud Zosano’s focus on developing a new acute treatment option for patients who experience the deep and relentless pain associated with cluster headache. I believe Zosano’s C213 drug candidate represents a patient-friendly therapeutic patch that has potential to rapidly and significantly reduce cluster headache pain over a sustained period. If proven successful in this late stage trial, C213 could be a very attractive therapeutic option for our community.”
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 the United States suffer from cluster headache.
About Zosano Pharma
Zosano Pharma Corporation is a clinical stage biopharmaceutical company focused on developing products where rapid administration of molecules with demonstrated safety and efficacy profiles may provide substantial benefit to patients, in markets where patients remain underserved by existing therapies. The company’s Adhesive Dermally-Applied Microarray (ADAM) technology consists of titanium micro-projections 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.
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
Sylvia Wheeler or Alexandra Santos
email@example.com or firstname.lastname@example.org