FREMONT, Calif., Nov. 02, 2015 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage specialty pharmaceutical company, today announced positive results from the Phase 1 clinical trial of its proprietary ZP-Triptan patch treatment for migraine.
ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual’s upper arm to deliver zolmitriptan to the body. The objective of the Phase 1 clinical study was to evaluate the tolerability and pharmacokinetics of the ZP-Triptan patch in healthy volunteers. The crossover study among 20 healthy volunteers tested five doses of ZP-Triptan compared to an oral administration of zolmitriptan and additionally a subcutaneous injection of sumatriptan. ZP-Triptan demonstrated rapid absorption compared to the zolmitriptan tablet. All treatments were well tolerated and no safety issues were identified. The results for the sumatriptan injection were similar to those reported in the literature.
| Cmax (SD) ng/ml | Tmax (range) minutes | AUC0-2hr (SD) ng/ml hour | AUC0-last (SD) ng/ml hour | |||||
| ZP-Triptan 0.48 mg | 1.8 (0.53) | 20 (2-30) | 2.1 (0.73) | 2.8 (1.36) | ||||
| ZP-Triptan 2 x 0.48 mg | 3.7 (1.05) | 20 (2-30) | 4.2 (0.95) | 6.5 (1.97) | ||||
| ZP-Triptan 1.9 mg | 6.8 (2.75) | 20 (2-30) | 7.4 (2.53) | 12.3 (4.31) | ||||
| ZP-Triptan 2 x 1.9 mg | 14.6 (4.46) | 17.5 (2-30) | 16.4 (5.34) | 27.8 (9.93) | ||||
| ZP-Triptan 3.8 mg | 22.6 (14.00) | 15 (2-30) | 19.3 (5.37) | 31.7 (8.35) | ||||
| Zolmitriptan Oral Tablet | 3.8 (1.51) | 60 (30-240) | 4.7 (2.24) | 22.2 (10.79) | ||||
Note: Mean values (median for Tmax) for the various zolmitriptan treatments are shown in the table above
"We are extremely pleased with the tolerability and pharmacokinetic results from our ZP-Triptan Phase 1 study,” said Thorsten von Stein, MD, PhD, Zosano Chief Medical Officer. “We expect that the demonstrated fast absorption will translate into fast pain relief. If so, ZP-Triptan’s fast absorption and simple injection-free administration may represent a strong product option for patients suffering from migraines. We look forward to discussing the program with the U.S. Food and Drug Administration (FDA) and to advancing clinical development."
The company, which holds exclusive global rights to develop and commercialize the ZP-Triptan patch, intends to discuss further development plans with FDA and expects to initiate a Phase 2 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.