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FDA guides phase 3 development of prebiotic for lactose intolerance
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Ritter Pharmaceuticals announced plans for phase 3 development of its novel prebiotic for the treatment of lactose intolerance after meeting with the FDA.
RP-G28 is a novel non-digestible oligosaccharide designed to stimulate the gut microbiota to metabolize lactose. Earlier this month, the company announced it significantly reduced symptoms in patients with lactose intolerance in a phase 2b/3 trial.
The company said it has included the FDA’s guidance in its phase 3 program to support a new drug application (NDA) for RP-G28.
“The FDA meeting was very collaborative and constructive in helping the company fully understand the agency’s objectives and expectations of the phase 3 program,” William Sandborn, MD, chief of the division of gastroenterology at University of California San Diego, said in a press release. “Having guidance and agreement on key clinical items such as screening methods to ensure an appropriate patient population, validated measures to capture appropriate clinical outcomes and well-defined endpoints for assessment, I believe the company is well-positioned to enter phase 3 trials to meet the FDA’s guidance on the expected clinical aspects needed for a successful NDA filing.”
The phase 3 clinical program will include two confirmatory clinical trials, like the phase 2b/3 trial in design and size, but with additional durability endpoints.
They will be multicenter, randomized, double-blind, placebo-controlled, parallel-group trials including a screening period, a 30-day treatment period and a 6-month post-treatment observation period. Improvements in composite symptom scores — measuring abdominal pain, cramping, bloating and gas — after a lactose challenge will serve as the primary endpoint.
The trials, which may be run in parallel, should commence during the first half of 2018, according to the press release.
“We are confident we can execute a successful phase 3 program furthering our goal to ultimately file a successful NDA and commercialize RP-G28 as the first FDA-approved treatment for lactose intolerance,” Andrew J. Ritter, co-founder and president of Ritter Pharmaceuticals Inc., said in the press release.
Disclosures: Ritter is co-founder and president of Ritter Pharmaceuticals. Sandborn reports he serves on the medical advisory board for Ritter Pharmaceuticals.