Therapies

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, a debilitating disease that affects over one billion people worldwide.

RP-G28 effectively stands out as the only therapeutic regimen impacting the natural history of the disease, alleviating the symptoms and reducing the frequency of symptomatic episodes of lactose intolerance. 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.

The Phase 2b/3 program is underway.  Results expected in 2017.

Phase 2a Results

Clinical Trial Results

A randomized, double-blind, placebo-controlled Phase 2a trial demonstrated that RP-G28 dramatically reduced the pain and symptoms of lactose intolerance. 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.

This research is particularly noteworthy because a beneficial change in the human microbiome of specific bacteria species was identified. This is the first time researchers have been able to identify a change in the specific bacteria species as a result of a course of treatment of a specific disease.

  • Subjects in the RP-G28 group reported a reduction in total symptoms after treatment. Reported symptom improvement continued 30 days post-treatment.
  • A majority of subjects who began the study with abdominal pain associated with dairy consumption reported no abdominal pain after taking RP-G28.
  • 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.

The manuscript detailing the RP-G28 clinic and results was published in Nutrition Journal.  A link to the publication can be found here.

Microbiome Results

The data from the Phase 2a trial further validates RP-G28’s mechanism of action and supports the product as a potential treatment for lactose intolerance.  The results of the study demonstrated that RP-G28 significantly modulated the gut microbiome composition of lactose intolerant individuals.  Significant changes in the diversity of the microbiota occurred in GOS/RP-G28 treated subjects upon reintroduction of dairy into the diet.

Notably, 90% of the RP-G28 treatment group showed a bifidogenic response compared to other GOS studies, which reported a bifidogenic response in 50% of the treated subjects.

The microbiome analysis also uncovered other potentially health-promoting bacteria, specifically Faecalibacterium, that were enhanced by feeding RP-G28.  This suggests that RP-G28 might have potential therapeutic benefits in inflammatory bowel disease and metabolic syndrome, among other diseases.

Ritter Pharmaceuticals’ clinical microbiome data from its Phase 2a clinical trial of RP-G28 in patients with lactose intolerance were published in the Proceedings of the National Academy of Science.  A link to the publication can be found here.

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