Cynapsus announces DSMB recommendations for CTH-300, CTH-301 clinical trials

Cynapses Therapeutics Inc., a pharmaceutical company that specializes in the central nervous system (CNS), this week announced the completion of its Data Safety and Monitoring Board (DSMB) review of the safety data from its Phase III CTH-300 and CTH-301 clinical trials.

The CTH-3001 trial will continue as planned based on the recommendation from the DSMB while the CTH-301 trial will be amended to permit at-home titration after the patient makes their initial clinic visit.

The Toronto-based company is developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the management of debilitating OFF episodes associated with Parkinson’s disease (PD).

“We are very pleased with the DSMB’s positive recommendations to assess an amendment to allow at-home dose titration in the CTH-301, six-month open label safety study,” Cynapsus President and CEO Anthony Giovinazzo said.

The DSMB is made up of experts from the clinical medicine biostatics and trial methodology fields and operates under an Food and Drug Administration-approved charter.

“This decision is based upon the positive safety signal seen during titration in the CTH-300 double-blind 12-week efficacy study,” Cynapsus CMO Dr. Albert Agro said. “Allowing the trial to proceed with the modification for at-home titration is expected to make it more convenient for PD patients to treat their OFF episodes. We believe this change may assist with patient compliance and allow Cynapsus to assess results in a more real-world setting.”