FREMONT, Calif., Oct. 13, 2015 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage specialty pharmaceutical company, today announced positive results from the Phase 2 clinical trial of its proprietary, rapid onset, transdermal ZP-Glucagon patch for severe hypoglycemia.
The objective of the Phase 2 clinical program was to evaluate the safety and efficacy of the ZP-Glucagon patch versus standard-of-care in reversing insulin induced hypoglycemia in adult subjects with Type 1 diabetes. Two doses of the ZP-Glucagon patch (0.5mg and 1.0mg) were compared to two doses of intramuscular injections (0.5mg and 1.0mg) in an open-label, randomized, four-way crossover study design (n=16 subjects).
Both ZP-Glucagon patch doses normalized blood sugar in 100 percent of the subjects. Both patch doses had rapid onset of action and time to glucose response was similar among the two modes of administration. All treatments were well tolerated and no new safety issues were identified.
"Achieving positive results from this Phase 2 study with the Zosano ZP-Glucagon patch is another significant milestone for the company," said Thorsten von Stein, Chief Medical Officer. "ZP-Glucagon's dry, stable formulation and simple press-and-apply application represents a significant improvement over the currently marketed products for treatment of severe hypoglycemia, which often require a lay person to deliver an injection with a cumbersome preparation and reconstitution process."
The company, which holds exclusive rights to develop and commercialize the ZP-Glucagon patch, intends to discuss further development plans with the U.S. Food and Drug Administration (FDA) and is currently evaluating the potential to initiate a pivotal Phase 3 clinical trial in 2016.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma's microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma's microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.