FDA digests Ritter's mid-stage microbiome data

Dive Brief:

  • The Food and Drug Administration is scheduling an end of Phase 2 meeting with Ritter Pharmaceuticals to look at RP-G28's Phase 2b/3 results and help the company plan its Phase 3 trial.
  • In 377 patients with lactose intolerance, RP-G28 met its primary endpoint – improving abdominal symptoms – with improvement in 40% of the treated patients compared with 26% of the placebo group. This was clinically meaningful, but not statistically significant. 
  • Ahead of the Phase 3 meeting, Ritter has begun manufacturing efforts and anticipates starting the late-stage study in the first half of 2018. 

Dive Insight:

While lactose intolerance may be thought of as a food fad and part of so-called "clean eating," people who are truly lactose intolerant can be sensitive to even small amounts of milk, developing diarrhea, bloating, stomach cramps, gas and nausea.

There are currently no FDA-approved treatments for lactose intolerance, but Ritter Pharmaceuticals aims to fix the intolerance by fixing the gut microbiome. RP-G28 is a non-digestible oligosaccharide that is designed to boost and adapt the gut bacteria to metabolize lactose in order to improve lactose intolerance. It is taken mixed into water over 30 days, aiming for a long-term impact on the condition.

In Ritter Pharmaceuticals' study, the results showed improvements that were better than placebo based on a new primary endpoint, a composite of abdominal symptoms including pain, cramping, bloating and gas. Ritter discussed the endpoint with the FDA before unblinding the data, and has incorporates the FDA’s recommendations in its data analysis.

"The fact that the company was able to develop a well-defined clinical outcomes instrument to quantify clinical meaningfulness in lactose intolerance patients is an important outcome of the trial and contribution to the field. We need to remember, there was no standard test to evaluate lactose intolerance symptoms prior to this study," said William Chey, Director of the GI Physiology Laboratory at University of Michigan.

One small hiccup though. While the majority of the analyses showed positive outcome measures that, according to the company, pointed to a clear drug effect, one study center (72 of 377 patients) showed significant irregularities in results, and these will require more analysis to get behind the root cause.

Ritter will be discussing the anomalies with the FDA as part of the end of Phase 2 meeting, as well as whether the composite endpoint results are sufficient to help support an eventual New Drug Application filing. Ritter is planning a confirmatory Phase 3 study program, expected to begin during the first half of 2018, and hopes that the results from this could further support an NDA.

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Filed Under: Clinical Trials Regulatory / Compliance
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