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.

Preparation for a Phase 2b program is underway.

Phase 2 Results

A randomized, double-blind, placebo-controlled Phase 2 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 below:

Manuscript

 

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