Ritter Pharmaceuticals Inc. reported positive topline results from the phase 2b/3 clinical trial evaluating RP-G28 in subjects with lactose intolerance.
The study showed "clinically meaningful benefit" by reducing lactose intolerance symptoms in subjects. The primary endpoint met statistical significance, in which 40% of the pooled dosing group and 26% of the placebo group responded.
There were no significant adverse events reported from the use of the treatment.
Ritter intends to discuss the trial's results with the U.S. FDA and the design of a confirmatory phase 3 trial at an upcoming end-of-phase 2 meeting.
The company will then submit a new drug application upon the completion of its planned phase 3 study of RP-G28.