Our Parkinson's Place: RESEARCH REPORT UPDATE CYNA: CYNAPSUS SNAGS FAST TRACK DESIGNATION FOR APL-130277 TO TREAT PARKINSON’S DISEASE (PD)

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Monday, August 29, 2016

RESEARCH REPORT UPDATE CYNA: CYNAPSUS SNAGS FAST TRACK DESIGNATION FOR APL-130277 TO TREAT PARKINSON’S DISEASE (PD)

By Anita Dushyanth, PhD

08/29/2016

There has been a series of positive news flow from CYNA (NASDAQ:CYNA) since our previous update

In mid-August 2016, the company announced that after reviewing the safety data from CTH-300 and CTH-301 clinical trials, the Data Safety and Monitoring Board (DSMB) recommended to continue the CTH-300 trial as planned. Additionally, the study was amended to allow for at-home titration, after the patient’s initial visit to the clinic. There may be several health and economic benefits from treatments administered at home, such as the reduction in healthcare service costs and waiting times. The at-home treatment option increases convenience and for PD patients to treat their OFF episodes which may consequently improve patient compliance. Further, it allows for assessment of results in a real-world setting

Today (August 29, 2016) the company announced that the FDA has granted Fast Track Designation for APL-130277. The Fast Track program was put into place under the FDA Modernization Act of 1997. The Fast Track designation allows expedited review of new drugs that are intended to treat serious conditions as well as demonstrate the potential to address an unmet medical need. The designation allows CYNA to have a rolling review with the FDA during the submission process and this is because the Fast Track designation allows the following:

- Frequent communication (written/in-person meeting) with the FDA to discuss the clinical development plan and trial design for the drug

- Relaying relevant data to support drug approval

- Eligibility for an accelerated approval and priority review, including the submission of a New Drug Application (NDA) on a rolling basis. This implies that CYNA can submit those sections of an NDA that are completed, to be reviewed by the FDA, instead of waiting to complete every section and then submit the entire application for review.

Currently, PD has very few therapeutic options that work and the treatment typically given is Sinemet® (Carbidopa/Levodopa). While apomorphine has been the holy grail in treating advanced PD patients, the high cost of the drug, the necessity of co-therapies for prevention of side effects and the subcutaneous administration has restricted its use. The sublingual formation of APL-130277 is attractive as it is definitely user friendly and less painful as compared to the injectable drug. CYNA had shown compelling clinical data of APL-130277 in PD and therefore, regulators were convinced to approve the fast-track status. The Fast Track program allows frequent communication between the FDA and management to ensure proper execution of the clinical trials to gather relevant data.

Cynapsus also provided update on completion timelines for their clinical trials. Based on patient visit schedules, post the dose titration phase, top line data for the Phase 3 Efficacy trial CTH-300 is expected in mid-to-late fourth quarter of 2016. Furthermore, the CTH-201 Phase 2 Thorough QT study, is expected to commence in the fourth quarter of 2016, and is planned to be completed in the first half of 2017.

For a free copy of the full research report, please email scr@zacks.com with CYNA as the subject.

http://scr.zacks.com/News/Press-Releases/Press-Release-Details/2016/CYNA--Cynapsus-Snags-Fast-Track-Designation-for-APL-130277-To-Treat-Parkinsons-Disease-PD/default.aspx