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.
Forward-Looking Statements
This press release contains forward-looking statements regarding the timing of clinical trial data and other expectations, beliefs and future events. 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 Zosano Pharma Corporation’s Annual Report on Form 10-K for the year ended December 31, 2014 filed with Securities and Exchange Commission on March 26, 2015. Although the company believes that the expectations reflected in these forward-looking statements are reasonable, it 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 Pharma and Zosano Pharma assumes no obligation to update any such forward-looking statements.
Zosano Contact:
Vikram Lamba
Chief Executive Officer
510-745-1200
Investor Contact:
Patti Bank
Westwicke Partners
415-513-1284
patti.bank@westwicke.com
Media Contact:
Jamie Lacey-Moreira
PressComm PR, LLC
410-299-3310
jamielacey@presscommpr.com
http://ir.zosanopharma.com/releasedetail.cfm? ReleaseID=936338
