Completed Phase 2b Study in Parkinson’s Disease
A Multicenter, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson’s Disease Related Constipation (KARMET).
The Phase 2b study was a randomized, placebo-controlled, double-blind study involving 150 patients with PD and constipation. Following a two-week baseline period, patients were stratified to start at high dose or low dose depending on baseline constipation severity and randomized to receive ENT-01 or placebo. Dosing was escalated every 2-3 days and “fixed” for the remainder of the 25-day treatment period. All patients were then placed on placebo for 2 weeks, followed by a 4-week wash-out.
Efficacy analyses were performed on all patients who had received at least 7 days of medication (n=136). The primary endpoint, defined as the change in complete spontaneous bowel movement (CSBM) from baseline to the end of the 3-week treatment period was significantly better in the treatment group compared to placebo (p=0.0001). The improvement persisted 2-weeks (p=0.02) and 6-weeks (p=0.05) after discontinuation of study medication.
To read the entire press release (from January 27, 2022) related to top-line results, please visit our News section. You can also watch a replay of the conference call, during which Dr. Denise Barbut, MD, FRCP, Co-Founder, President and CMO of Enterin, shared the results.