TORONTO, CANADA – Cynapsus Therapeutics Inc. (CTH: TSX-V) (CYNAF: OTCQX), a specialty pharmaceutical company focused on Parkinson's disease, today announced that following communication from the United States Food and Drug Administration ("the FDA") on July 16, 2014, Phase 2 clinical studies for APL-130277 will commence immediately. Specifically, clinical study CTH-105 will be initiated per the proposal submitted to the FDA under the Company´s Investigational New Drug (IND) application. APL-130277 is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug in the United States, Europe, Japan and other countries, to rescue patients from "off" episodes experienced with Parkinson's disease.
CTH-105 is a Phase 2 clinical study of APL-130277. APL-130277 will be studied in 16 patients with Parkinson's disease who are naïve to the use of apomorphine and who experience at least one daily "off" episode, with a total duration of "off" in any 24-hour period of at least 2 hours. The first patients are expected to enter the screening phase before the end of July. This open-label study will examine the effect of APL-130277 on relieving "off" episodes over a single day, with dose-titration used to determine dose strengths necessary for future clinical development. In particular, the dose strength information is necessary in order to conduct the larger CTH-300a efficacy study in apomorphine naïve patients, which is expected to commence in Q4 2014.
CTH-300a is a double-blind, placebo-controlled, parallel-design study with Parkinson's patients who have at least one "off" episode every 24 hours, with total "off" time of at least 2 hours. The primary end point will be the change in the UPDRS III score.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of "off" motor symptoms of Parkinson's disease. Cynapsus' drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from "off" episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application ("NDA") expected to be submitted in 2016.
Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson's disease. Parkinson's disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Corporation's Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of patients experience "off" episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease's symptoms, and most drugs become less effective over time as the disease progresses.
More information about Cynapsus (TSX-V: CTH) (OTCQX: CYNAF) is available atwww.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.