A specialty pharmaceutical company, Ritter Pharmaceuticals, Inc. (Ritter), reported that the last patient has completed treatment in its phase II study for RP-G28, a first-in-class treatment for symptoms associated with lactose intolerance. This multi-centre, 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 II 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. “We are optimistic about the results of our phase II trial, and we look forward to sharing data from the study in the first quarter of 2012.”
Lactose intolerance is a common gastrointestinal disease affecting over 4 billion people worldwide. People with lactose intolerance have a low activity level of lactase, the enzyme responsible for breaking down human lactose, resulting in one or more of the cardinal symptoms; including abdominal pain, cramps, bloating, gas, and/or diarrhoea following the ingestion of lactose-containing foods.
RP-G28 has the potential to become the first FDA-approved drug for the treatment of lactose intolerance. Treatment with RP-G28 stimulates colonic growth and helps to colonize the colon with lactose-fermenting bacteria, which reduces lactose-derived gas production, and thereby mitigates the symptoms of lactose intolerance. It stands out as the only therapeutic regimen impacting the natural history of the disease and alleviating the symptoms of lactose intolerance on a long-term basis.
Ritter Pharmaceuticals is developing therapeutics based upon colonic adaptation to treat gastrointestinal diseases with an initial focus on lactose intolerance.