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CYNA shows positive results in late-stage study of its Parkinson's drug
Cynapsus' APL-130277 shows positive effects in late-stage Parkinson's study
Jul 18 2016, 17:18 ET | About: Cynapsus Therapeutics (CYNA) | By: Douglas W. House,
Thinly traded micro cap Cynapsus Therapeutics (NASDAQ:CYNA) is up 1% after hours on light volume in response to its announcement of positive results from its Phase 3 dose titration study, CTH-300, assessing APL-130277 for the treatment of OFF episodes in Parkinson's disease (PD) patients.
Data from the first 92 subjects showed a 22-point improvement from baseline to 30 minutes in a PD rating scale called MDS-UPDRS Part III. In addition, 60% of patients showed improvement in motor function between five and 12 minutes after dosing, improvement in motor function was maintained beyond 90 minutes and 83% of patients transitioned from OFF to fully ON.
The median dose of APL-130277 that turned patients to fully ON was 20 mg.The primary endpoint of CTH-300 is the mean change in motor function from baseline to 30 minutes at week 12 as measured by MDS-UPDRS MOTOR. According to ClinicalTrials.gov, the estimated study completion date is October.
A long-term safety study, CTH-301, is currently recruiting patients (participants in CTH-300 are eligible). It should be completed by November.The company plans to file its New Drug Application in the U.S. under the abbreviated 505(b)(2) pathway in H1 2017.
A pivotal study in Europe should start next quarter.
An OFF episode, a time during which PD patients are unable to perform routine activities like eating, bathing or dressing, is thought to occur when dopamine levels in the brain fall below a certain threshold. It is considered one of the greatest unmet medical needs of PD sufferers.APL-130277 is a sublingual (under the tongue) formulation of apomorphine.
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