Ritter Phase 3 trial of RP-G28 fails to demonstrate statistical significance
Ritter Pharmaceuticals announced that its Phase 3 clinical trial of RP-G28 for lactose intolerance failed to demonstrate statistical significance in its pre-specified primary endpoint. Top-line data from the 557-subject Phase 3 clinical trial indicates that RP-G28 provided significant symptom improvement in patients; however, there was no or little difference compared to placebo. The remaining secondary endpoints also missed statistical significance differences with treatment and placebo generally reporting similar results to each other. RP-G28 was generally well-tolerated, with placebo and treatment groups reporting similar safety profiles. "We are deeply disappointed in the results of the phase 3 clinical trial," said Ritter CEO Andrew Ritter. "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."