Becker's ASC Review spoke with William Chey, MD, of Ritter Pharmaceuticals' medical advisory board, about the first treatment for lactose intolerance, the company's RP-G28. The treatment has not yet received FDA approval.
Question: What's the significance of RP-G28? Will all lactose intolerant patients be able to benefit from the treatment?
Dr. William Chey: RP-G28 has the potential to become the first U.S. FDA-approved treatment for lactose intolerance, a condition that affects approximately 40 million Americans, of which 9 million are moderately to severely affected.
Our research has found that current management options are ineffective and fail to correct the root problem — the inability of affected individuals to enjoy milk and other dairy products without painful and embarrassing GI symptoms.
Approximately 82 percent of lactose intolerance patients experience symptoms at least weekly and 78 percent are interested in consuming dairy products without discomfort.1,2
Most commonly, physicians recommend that patients avoid dairy foods, which not only requires sacrifice but is hard to hard [to do] because many foods contain hidden lactose which can cause painful symptoms in moderately to severely affected persons.
Furthermore, lactase supplements are unreliable and only modestly effective. Ultimately, 60 percent of lactose intolerant patients continue to seek a better solution.1
Q: How exactly does RP-G28 modulate the gut microbiome? Could that aspect be tweaked and applied in other ways to treat other GI disorders?
WC: RP-G28 is a novel, nondigestible oligosaccharide of ultra-high purity. The understood mechanism of action of RP-G28 for mitigating lactose intolerance symptoms is by promoting adaptation of the gut microbiome.
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 to simple sugars which can be used by the host, reducing lactose fermentation by colonic bacteria to produce gas and short chain fatty acids which can trigger symptoms in persons with lactose intolerance.
After treatment for 30 days, patients are expected to be able to freely consume dairy products without symptoms.
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 this data, Ritter Pharmaceuticals plans to explore future opportunities in other indications for RP-G28.
Q: What's next for RP-G28?
WC: The first pivotal phase 3 trial of RP-G28 for the treatment of lactose intolerance is expected to initiate in the second quarter of 2018 and take approximately 12 months. There will be no interim data, and full results are expected after completion of the trial.
1 Objective Insights, "Market Research Analysis on Lactose Intolerance and RP-G28." June, 2012. 2 Engage Health, Inc., "Market Potential for an Rx and Nutritional Supplement Product for Lactose Intolerance in the US." June, 2008.