Cynapsus Therapeutics Commences Phase 2 Clinical Trials in the United States
TORONTO, CANADA – (Marketwired) – July 17, 2014 - 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 at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Forward Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable securities laws. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved". Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Cynapsus to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks and uncertainties relating to Cynapsus’ business disclosed under the heading “Risk Factors” in its March 26, 2014, Annual Information Form and its other filings with the various Canadian securities regulators which are available online at www.sedar.com. Although Cynapsus has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Cynapsus does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.
Source: Cynapsus Therapeutics
Posted: July 2014