Ritter Completes Phase 2 Clinical Study of RP-G28 for the Treatment of Lactose Intolerance
Ritter Pharmaceuticals, Inc. (Ritter) has announced the last patient has completed treatment in its Phase 2 study for RP-G28, a first-in-class treatment for symptoms associated with lactose intolerance.
This multicenter, randomized, double-blind, placebo-controlled, parallel group study evaluated the effectiveness, safety and tolerability of RP-G28 in subjects with symptoms associated with lactose intolerance.
The study aims to demonstrate a significant drug effect correlating microbial changes and patient reported symptom improvements.
Novel microbiome sequencing and genetic analysis will identify the microbiota of lactose intolerant individuals and contribute to the understanding of changes in colonic microflora, specifically, the modification and colonization by bacteria which improve lactose fermentation in the colon.
RP-G28 has the potential to become the first prescription drug approved for the treatment of lactose intolerance, a debilitating disorder with long-term consequences.
Lactose intolerance affects more than 80 million people in the United States and over 4 billion people worldwide.
"The completion of our Phase 2 study represents a major milestone for the company. The knowledge gained from this study is invaluable, as Ritter establishes a pathway to approval for RP-G28," said Andrew Ritter, president and chief executive officer of Ritter Pharmaceuticals.
Ritter continued, "We are optimistic about the results of our Phase 2 trial, and we look forward to sharing data from the study in the first quarter of 2012."