Ritter Pharmaceuticals announced that the phase 3 clinical trial of RP-G28 for lactose intolerance did not meet its primary or secondary end points.

The multicenter, randomized, double-blind, placebo-controlled, phase 3 trial evaluated the efficacy, safety and tolerability of RP-G28 on symptom reduction related to lactose intolerance. The study was designed for patients to undergo an initial 2-week screening period, followed by a randomized 30-day study drug treatment period, then a 90-day “real-world experience” period. The primary end point was change from baseline of the lactose intolerance symptom composite score, which included pain, bloating, cramping and gas of the abdomen; the secondary end point included the proportion of patients with a meaningful reduction in lactose intolerance composite score.

Results showed that there was little or no difference in symptom improvement with RP-G28 when compared with placebo (3.159 mean reduction with RP-G28 vs 3.420 mean reduction with placebo; P =.106; one-sided). Moreover, the proportion of responders with meaningful treatment benefit was found to be similar between the RP-G28 group and placebo group (36.2% vs 34.1%, respectively; P =.284; one-sided). 

Regarding safety, RP-G28 was generally well-tolerated with a similar safety profile to placebo.

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“We are deeply disappointed in the results of the phase 3 clinical trial,” said Andrew J. Ritter, CEO at Ritter Pharmaceuticals. “We believe the clinical trial was well-designed and executed. We are continuing to analyze the results of the trial to better understand the data and clinical outcomes to assess a path forward, which may include alternative strategic options for the Company.”

According to the Company, RP-G28 works by stimulating the growth of lactose-metabolizing bacteria in the colon.

For more information visit ritterpharmaceuticals.com.