US-based Ritter Pharmaceuticals has reported positive additional results from a Phase IIb/III trial of its product candidate RP-G28 in patients suffering from lactose intolerance (LI).
Lactose is a sugar present in milk and related products, while RP-G28 is non-digestible oligosaccharide currently being developed to regulate gastrointestinal (GI) tract bacteria to metabolise lactose for improved tolerance.
According to the results, RP-G28 showed a clear drug effect with a significant and clinically meaningful reduction in LI symptoms as assessed by different global and real world outcome measures.
Ritter Pharmaceuticals president and co-founder Andrew Ritter said: “As we continue to evaluate the results of this trial, we are increasingly excited by the strength of the data supporting RP-G28’s potentially significant and durable real-world treatment effect for patients suffering from lactose intolerance.”
During the multi-centre, randomised, doubled-blind, placebo-controlled, parallel-group Phase IIb/III trial, the efficacy, safety and tolerability of RP-G28 were evaluated in 377 subjects.
The trial comprised a 30-day treatment phase and a post-treatment real-world observation phase of additional 30 days, during which subjects consumed lactose containing food products.
With a composite primary endpoint of abdominal pain, cramping, bloating and gas movement, the trial monitored post-treatment LI symptoms using a Likert scale.
After the re-introduction of dairy and milk products into subjects’ diets, 83% reported LI symptoms relief and 82% experienced no or mild symptom severity.
Furthermore, RP-G28 was found to be safe without any serious adverse events related to the treatment.
Ritter intends to initiate a Phase III programme for RP-G28 in the first half of next year and has already started manufacturing efforts.
Image: Lactose is found in milk and dairy products. Photo: courtesy of World's Direction/flickr.