Ritter Pharmaceuticals starts phase 2B/3 trial of RP-G28 in lactose intolerance

The trial is a double-blind, placebo-controlled, three arm, multicenter study enrolling approximately 350 patients with Lactose Intolerance symptoms. Patients will undergo a 30-day treatment process, followed by a 30-day post-treatment evaluation.

In addition, the study will further evaluate participant’s microbiome, expanding knowledge of the effects RP-G28 may have on positively adapting and shifting the gut microbiota for health benefits.

The company estimates that the study will take approximately 10 months to complete and top-line data is expected in early 2017.

Ritter Pharmaceuticals founder and president Andrew Ritter said: "The initiation of this trial demonstrates continued progress in the pursuit of developing the first FDA approved treatment for lactose intolerance. It is one of the first therapeutic agents shown to positively adapt the microbiome of lactose intolerance patients.

"There is a large market opportunity for a safe and effective treatment for this condition, and we believe that our treatment can have a tremendous impact on the day-to-day lives of millions who suffer from lactose intolerance around the globe."