Ritter Pharmaceuticals Announces Lactose Intolerance Treatment, RP-G28, Demonstrated Efficacy and Clinically Meaningful Benefit in Phase 2b/3 Clinical Trial - Seite 2

Topline Trial Results

The primary endpoint met statistical significance, in which 40% of the pooled dosing group and 26% of the placebo group responded (p=0.0159). Because the primary analysis was statistically significant, the primary endpoint comparison between the high dose group and the placebo group was then tested and also met statistical significance. This endpoint compared the high dose group, of which 38% of whom were treatment responders compared to the placebo group of which 26% of whom were treatment responders (p=0.0294). The comparison between the low dose group and the placebo group further met statistical significance (p=0.0434). Due to significant irregularities demonstrated at one study center, the data from this center were excluded from the primary analysis population (n=296). The Company is continuing to examine this site's significant differences from the other clinical centers. 

In the entire study population taking at least one dose of drug (n=368), including the excluded center, the comparison between the pooled treatment groups and the placebo group narrowly missed statistical significance (p=0.0618), in which 40% of the pooled treatment group responded compared to 31% of the placebo group. Both low dose and high dose group arms demonstrated a higher proportion of responders than the placebo group.

No significant adverse events (SAEs) were reported from treatment. Safety measurements showed no difference between treatment and placebo patients.

Additional Study Findings

• Consistent treatment benefit of RP-G28 compared to placebo was seen in key individual symptoms (abdominal pain, cramping, bloating, gas, bowel urgency and composite abdominal symptoms) both immediately post-dosing and 30-days post-dosing. These reductions in symptoms demonstrate improved lactose tolerance and 30-days of durability of treatment effect.
  
  
• Global patient assessment tools report consistent 30-day durability of treatment benefit, demonstrating that the pooled treatment groups reported statistically significant greater positive responses compared to the placebo group when asked about the following questions: "satisfaction with the ability of the study medication to prevent or treat your lactose intolerance symptoms" (PASI), improvement in "overall severity of your lactose intolerance symptoms" (PGIS) and "adequate relief from your lactose intolerance symptoms" (PAARI).