Cynapsus Therapeutics Inc (OTCMKTS:CYNAF) confirmed that it had completed an End-of-Phase 2 discussion with the U.S. FDA related to its Cynapsus’ APL-130277 drug for the treatment of OFF episodes seen in Parkinson’s disease. The company has recorded the final meeting minutes.
At the meeting, a deal was finalized on the duration, size and design for the Phase 3 program clinical trials. Also, the primary and secondary endpoints were finalized. As a result, Cynapsus intends to commence a Phase 3 trial evaluating the efficacy and safety of APL-130277 in Parkinson’s disease patients in 2Q2015.
The management view
Anthony Giovinazzo, the CEO of Cynapsus said that the management is pleased with the final result of the End-of-Phase 2 meeting with the FDA. The company appreciates the constructive feedback on its development plan. Cynapsus now have the guidance of FDA on the efficacy and safety requirements for completion of a registration plan for drug APL-130277 in patients suffering from Parkinson’s disease. He added that a great deal of planning and effort are vested into preparing for Phase 3 development trial and the team is focused on the commencement of the CTH-300 and CTH-301 Phase 3 trials in 2Q2015 with an objective to submitting a New Drug Application in 2016.
In the first week of February, Cynapsus Therapeutics Inc (OTCMKTS:CYNAF) conducted its End-of-Phase 2 planned meeting with the FDA. The company is pursuing an innovative formulation of apomorphine that is a safe, convenient and tolerable sublingual thin filmstrip. It is identical to the active Pharma component in the FDA passed subcutaneous injection, known as Apokyn®. The new drug candidate is being developed as an adjunctive treatment for the management of OFF episodes in patients with PD. The 505(b)(2) regulatory guidelines will require the company to provide statistically noteworthy clinical evidence that patients with PD experience relief from their OFF episodes.