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Novel prebiotic shows continued reductions in lactose intolerance symptoms
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RP-G28, a novel non-digestible oligosaccharide designed to stimulate the gut microbiota to metabolize lactose, significantly reduced symptoms in patients with lactose intolerance, according to a press release.
Ritter Pharmaceuticals Inc. announced this additional finding from its phase 2b/3 trial study that researchers designed to assess the efficacy, safety and tolerability of 2 dosing regimens of RP-G28. The trial comprised 377 patients with lactose intolerance and included a 30-day course treatment phase and a 30-day post-treatment “real world” observation phase where patients had foods containing lactose reintroduced into their diets, per the press release.
Additional analysis from the trial demonstrated clear drug effect with significant positive reductions in key symptoms of lactose intolerance that can benefit patients, and safety with no serious adverse events, according to the release.
Participants reported improvement in the severity of each symptom, with 56% reporting improvement in abdominal pain, 55% for cramping, 44% for gas movement and 55% for bloating. Additionally, 31%, of patients reported they experienced complete elimination of abdominal pain, 35% for cramping, 16% for gas movement and 30% for bloating. After adding dairy product back into their diets 30-days post-treatment, 83% of patients reported adequate relief from lactose intolerance symptoms, 82% reported no or mild symptom severity and 40% reported much/very much improvement in symptoms after incorporating dairy back into their diets, according to the release.
“The further on-going analysis of our study data we are releasing today is proving to be important for demonstrating in the real-world that treatment with RP-G28 can safely yield both a clear drug effect and a clinically meaningful benefit for patients by using a study design and outcome measurements recommended by the FDA and as reported by patients,” Michael Step, CEO of Ritter Pharmaceuticals, said. “We are looking forward to completing our phase 3 program with the ultimate objective of providing a durable treatment to people who suffer from lactose intolerance.”
The End of Phase 2 meeting will take place by the end of 2017 with the FDA, and Ritter Pharmaceuticals hopes to begin the phase 3 clinical trial in 2018.
Disclosures: Step is CEO of Ritter Pharmaceuticals.