Ritter Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics based upon colonic adaptation to treat gastrointestinal diseases with an initial focus on lactose intolerance, reported positive results from its phase 2 study of RP-G28, the first-in-class treatment of lactose intolerance.
According to a company press release, treatment with RP-G28 was shown to improve digestive symptoms associated with lactose intolerance, including abdominal pain. Importantly, the reduction of breath hydrogen production after a lactose load was measured, providing evidence of a clinically meaningful biological effect.
This study marks a major milestone in lactose intolerance research, as it represents the first adequate and well-controlled phase 2 study for a prescription drug candidate for patients with lactose intolerance.
Subjects in the RP-G28 group reported a reduction in total symptoms of 56 per cent after treatment which increased to nearly a 70 per cent reduction by 30 days post-treatment. Importantly, subjects had a statistically significant decrease in abdominal pain (p = 0.03) 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. Subjects treated with RP-G28 had a 15 per cent greater decrease in hydrogen production as compared to those receiving placebo. RP-G28 was well tolerated with no significant study-drug related adverse events. Ritter Pharma plans to release the complete data set for the phase 2 trial at an upcoming major medical meeting or in a peer-reviewed journal.
“We are very pleased with the results of our phase 2 trial of RP-G28, demonstrating improvements in both lactose digestion and symptoms,” stated Andrew Ritter, Ritter Pharma’s president and chief executive officer. “These data will enable us to advance through late-stage clinical development in order to bring RP-G28 to the many patients suffering from inadequately treated lactose intolerance.”
“There are no effective or reliable long-term treatments currently available for those with lactose intolerance,” said Dennis Savaiano, Ph.D., professor of Foods and Nutrition and former dean at Purdue University, who is considered one of the world’s foremost experts on lactose intolerance. “With these strong results, RP-G28 has great potential to help millions of patients with lactose intolerance consume dairy products again.”
RP-G28 has the potential to become the first FDA-approved drug for the treatment of lactose intolerance. Treatment with RP-G28 stimulates colonic growth and helps to colonize the colon with lactose-fermenting bacteria, which reduces lactose-derived gas production, and thereby mitigates the symptoms of lactose intolerance. RP-G28 stands out as the only therapeutic regimen impacting the natural history of the disease and alleviating the symptoms of lactose intolerance on a long-term basis.
Lactose intolerance is a common gastrointestinal disease affecting over 80 million Americans and four billion people worldwide. People with lactose intolerance have a low activity level of lactase, the enzyme responsible for breaking down human lactose, resulting in one or more of the cardinal symptoms; including abdominal pain, cramps, bloating, gas, and/or diarrhea following the ingestion of lactose-containing foods.