Novel prebiotic could help treat millions with severe lactose intolerance

Dennis A. Savaiano

RP-G28, a novel prebiotic in development for the treatment of lactose intolerance has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions of Americans, according to the developer Ritter Pharmaceuticals.

To learn more about its mechanism of action, the target patient population, and the late phase development program, Healio Gastroenterology and Liver Disease spoke with Ritter Pharmaceuticals’ medical advisory board member Dennis A. Savaiano, PhD, Meredith Professor in the department of nutrition science at Purdue University.

Healio: We’ve previously reported RP-G28 is a novel prebiotic that stimulates gut microbiota to metabolize lactose. Can you elaborate on how this approach works?

Savaiano: RP-G28 is a novel, non-digestible oligosaccharide of ultra-high purity. The understood mechanism of action of RP-G28 for mitigating lactose intolerance symptoms is by promoting colonic adaptation. Specifically, RP-G28 preferentially stimulates the growth of lactose-metabolizing bacteria in the GI tract, which compensates for the lack of endogenous lactase activity. The result is the breakdown of lactose, reducing gas production and water retention, thus reducing gastric symptoms for patients. After treatment for 30 days, patients are expected to be able to freely consume dairy products without symptoms.

Healio: Can you describe the unmet need that this therapy would address if approved? How would patients use it, and would it completely cure their lactose intolerance, allowing them to consume dairy products with no restrictions?

Savaiano: RP-G28 has the potential to become the first U.S. FDA-approved treatment for lactose intolerance, a condition that affects approximately 40 million people in the U.S. with a target market of 9 million moderate to severe individuals, representing a significant medical need. Our research has found that current management options are simply not effective or do not solve the root issue of patients desiring to enjoy milk and other dairy products without painful and often embarrassing symptoms of lactose intolerance. Approximately 82% of lactose intolerance patients experience symptoms weekly or more frequently and 78% of lactose intolerance patients are interested in consuming dairy products without discomfort. A physician’s primary recommended solution is for patients to avoid dairy foods, which is nutritionally unsound, leading to lower calcium intakes and increasing the risk of bone disease. Furthermore, 60% of patients continue to seek a better solution than lactase supplements, which reinforces unsatisfactory treatment options.

RP-G28 comes in a powder form in single dose packets to be mixed in water and dissolved before drinking. It is taken twice daily for 30-days. After the 30-day course of treatment, it is expected that patients will be able to freely consume dairy foods symptom-free. Durability of treatment is still being assessed clinically, but we predict patients may be tolerant for a long time. A particular subset of patients may need to take another treatment periodically.

Healio: Could this targeted prebiotic approach potentially be used to treat other conditions?

Savaiano: Recently, Ritter Pharmaceuticals reported microbiome data from its phase 2b study of RP-G28 demonstrating a beneficial adaptation of the gut microbiome. Specifically, a dramatic increase in the species of Bifidobacterium was observed. This is significant since Bifidobacterium have proven health benefits for both the gastrointestinal tract and the immune system. Based on these data, Ritter Pharmaceuticals plans to explore future opportunities in other indications for RP-G28.

Healio: What is the future development timeline?

Savaiano: The first pivotal phase 3 trial of RP-G28 for the treatment of lactose intolerance is expected to initiate in Q2 2018 and take approximately 12 months. There will be no interim data, and full results are expected after completion of the trial. Ritter Pharmaceuticals is planning on presenting two abstracts based on additional clinical data and findings from its phase 2b trial during the upcoming Digestive Disease Week, being held June 2-5 in Washington, D.C.

References:

Objective Insights, “Market Research Analysis and Forecasts on Lactose Intolerance and RP-G28.” June 2012.

Engage Health Inc., "Market Potential for an Rx and Nutritional Supplement Product for Lactose Intolerance in the US.” June 2008.

Disclosures: Savaiano is a member of Ritter Pharmaceuticals’ medical advisory board.