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news.Cynapsus Therapeutics, a specialty pharmaceutical company focused on Parkinson's disease, has announced that following communication from the United States Food and Drug Administration, Phase II clinical studies for APL-130277 will commence immediately.
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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 II 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.