The company develops novel therapeutics that modulate the human gut microbiome to treat gastrointestinal diseases.
Andrew J. Ritter, founder and president of Ritter Pharmaceuticals, said, "We are pleased to have initiated dosing in the Phase 2b/3 clinical trial of our lead product candidate, RP-G28 for the treatment of lactose intolerance. This puts us on the path towards potential commercialization of the first FDA-approved drug for this indication."
Dennis Savaiano, Ph.D., Professor of Nutrition Science at Purdue University and chair of Ritter Pharmaceuticals' medical board, said, "Millions of Americans and many more worldwide suffer from this condition with few treatment options available. This study will assist in the development of a medication that may help many people around the globe who suffer from lactose intolerance."
The Phase 2b/3 trial is a double-blind, placebo-controlled, multicenter study to determine the efficacy and safety of two RP-G28 dosing regimens on symptoms related to lactose intolerance relative to placebo treatment.
Dairy re-introduced to diet
Approximately 350 patients will be randomized at up to 20 locations within the United States.
Patients will undergo a 30-day treatment process, followed by a 30-day post-treatment evaluation where dairy will be included back into the diet.
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 expects top-line data by early 2017.