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

Global Assessment Tool		All Sites (Excluding Irregular Center)		All Sites
Patient Assessment of Satisfaction (PASI)		p=0.0035*		P=0.009*
Patient Global Impression of Severity (PGIS)		p=0.0032*		p=0.031*
Patient Assessment of Adequate Relief (PAARI)		p=0.042*		p=0.063
*= Statistical Significance

To fully explore meaningfulness of treatment benefits, a number of additional endpoints and analyses are under further review, including gut microbiome outcomes.

William Sandborn, M.D., Chief, Division of Gastroenterology at University of California San Diego comments, "I believe the totality of the results and the multitude of positive outcome measures demonstrates there is a clear treatment benefit for subjects taking RP-G28. The responder composite score instrument, which we worked with the FDA to establish, performed as anticipated to best quantify and evaluate clinically meaningful treatment benefit for lactose intolerance sufferers. This study was groundbreaking for both its size in lactose intolerance and in its design to identify clinically meaningful benefit to patients in the context of an evolving regulatory framework to demonstrate effect."