LOS ANGELES, CA -- (Marketwire) -- 01/07/13 -- Nearly 40 million Americans are lactose intolerant and must significantly limit -- or avoid -- milk and dairy products, or suffer with embarrassing and debilitating gastrointestinal pain. Despite the availability of lactose-free food options and over the counter remedies, a recent study by Objective Insights reported that 45% of patients with Lactose Intolerance (LI) do not find effective relief with these options, and 70% of them claim that a more reliable and medically sound alternative is needed.
Ritter Pharmaceuticals is developing the first prescription drug candidate for LI and has completed a Phase 2 clinical study aimed at evaluating the drug candidate's potential benefits for LI patients. Ritter's drug candidate, RP-G28, is a non-digestible carbohydrate used to stimulate colonic growth of lactose-fermenting bacteria in the large intestine. The study results showed proof-of-concept that RP-G28 was safe and well tolerated and, most notably, improved lactose digestion and reduced lactose intolerance symptoms in LI patients. In addition, the favorable results from this study support further investigation of RP-G28 and provide valuable information for the design of the future clinical studies.
Phase 2 Study of RP-G28 for Lactose Intolerance
The double-blinded, randomized, multi-center, placebo-controlled Phase2 study of 62 patients evaluated RP-G28 in lactose intolerant patients over a treatment period of 35 days and at 30 days post-cessation of treatment. The primary endpoints included tracking patients' gastrointestinal symptoms via a Likert Scale at baseline, day 36 and day 66; as well as the measurement of hydrogen gas levels in their breath following a lactose challenge. Statistically significant results reported that 30 days after completion of a single treatment cycle, 6 times as many patients in the treatment group versus the placebo group reported lactose tolerance -- the ability to consume dairy products again without symptoms. The patients in the RP-G28 treatment group reported overall reduction in symptoms, including reduction in abdominal pain, abdominal cramping, bloating and flatulence at day 36. In addition, the treated patient group had a greater reduction in hydrogen gas production compared with the placebo group post-treatment. RP-G28 appears to be an effective strategy for improving lactose digestion and reducing lactose intolerance symptoms in LI subjects. Ritter expects to report the complete results from this Phase 2 clinical study in a peer-reviewed journal.
"These results show that RP-G28 may one day allow lactose intolerant patients the freedom to consume dairy foods again without experiencing embarrassing and painful GI symptoms," said Andrew J. Ritter, president and CEO of Ritter Pharmaceuticals, Inc. "We anticipate that the next clinical study evaluating RP-G28 will begin later this year," he added.
Lactose Intolerance is a common condition attributed to insufficient levels of the enzyme lactase which is needed to properly digest lactose, a complex sugar found in milk and milk containing foods. People with lactose intolerance who ingest lactose-containing foods may experience painful and embarrassing digestive symptoms. The condition is prevalent worldwide, where it is estimated that more than 1 billion people may be lactose intolerant. To date, no medical treatment is available to help those who suffer with this condition.
Ritter Pharmaceuticals (www.ritterpharmaceuticals.com)
Ritter is a specialty pharmaceutical company developing therapeutics based upon colonic adaptation to treat gastrointestinal diseases with an initial focus on lactose intolerance. Colonic adaptation improves colon function by selectively increasing the growth of beneficial bacteria in the colonic ecosystem. Ritter is rapidly establishing itself as the world's leader in lactose intolerance research and development. Ritter's RP-G28 is the first investigational drug candidate to complete a Phase 2 clinical study for lactose intolerance, and continues to be developed as a potential medical therapy for patients with LI.