Ritter Pharmaceuticals | Therapeutic Treatments for Gastrointestinal Diseases

RP-G28: Therapeutic Treatment for Lactose Intolerance

Overview

RP‐G28 has the potential to become the first FDA‐approved drug for the treatment of lactose intolerance.

RP‐G28 is an orally administered, proprietary oligosaccharide with an excellent safety profile. It is the only therapeutic regimen today potentially impacting the natural course of the disease and alleviating the symptoms of lactose intolerance on a long-term basis. The product is administered consecutively over a set period with only periodic maintenance therapy thereafter.

RP-G28’s understood mechanism of action is based on colonic adaptation. The product stimulates the growth of lactose-metabolizing bacteria in the colon, which reduces lactose-derived gas production, and thereby mitigates the symptoms of lactose intolerance in the process.

Phase 2 Results

A randomized, double-blind, placebo-controlled Phase 2 trial was conducted on RP-G28 in 2011.

The study marks a major milestone in lactose intolerance research, as it is the first well-controlled Phase 2 study for a prescription drug candidate for patients with lactose intolerance.

Treatment with RP-G28 was shown to improve digestive symptoms associated with lactose intolerance.  Importantly, the reduction of breath hydrogen production after a lactose load was measured, providing evidence of a clinically meaningful biological effect.

• Subjects in the RP-G28 group reported a reduction in total symptoms after treatment. Reported symptom improvement continued 30 days post-treatment.
• Subjects had a statistically significant decrease in abdominal pain compared to those receiving placebo
• The reduction in total symptoms was consistent with the improvement in hydrogen breath test results following post-treatment lactose challenge as compared to baseline (pre-treatment) results.
• RP-G28 was well tolerated with no significant study-drug related adverse events.

Ritter plans to release the complete data set for the Phase 2 trial at an upcoming major medical meeting and/or in a peer-reviewed journal.

For more details of our Phase 2 trial results: Ritter Announces Positive Phase 2 Clinical Data