Shares of thinly-trade Ritter Pharmaceuticals Inc RTTR are plunging to an all-time low Friday morning following a clinical readout.
Ritter said the Phase 3 trial of RP-G28 that's being evaluated for lactose intolerance failed to show statistical significance in its pre-specified primary endpoint.
Primary, Secondary Points Not Met
Topline data from the 557-subject Phase 3 trial showed the investigational compound brought about a significant symptom improvement in patients, but there was no, or little difference compared to placebo.
The Ll symptom, which comprises a composite score of abdominal pain, cramping, bloating and gas, showed a mean reduction of 3.159 at day 61, or 30 days post-treatment, compared to the baseline. For the control group, the reduction reported was 3.420.
The investigational compound also missed the first secondary endpoint of responders with a meaningful treatment benefit of 36.2% compared to 34.1% for the placebo group.
The remaining endpoints also missed statistically significant differences, although RP-G28 was found to be generally well-tolerated and safe.
The late-stage trial was a randomized, double-blind, placebo-controlled trial, where participants underwent a 2-week screening period, followed by a randomized 30-day treatment period. This was followed by a 90-day real-world experience period to assess the response and the durability of response after treatment, as patients continue with their normal diets, including dietary products.
Strategic Review On The Cards
"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," said CEO Andrew Ritter.
Ritter is a single-product candidate company, which is evaluating RP-G28 for multiple indications, including lactose intolerance, metabolic syndrome, liver diseases and immuno-oncology.
The stock traded lower by 69% to 33 cents at time of publication.
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