Marks scientific publication of first Investigational New Drug treatment for LI
LOS ANGELES, Calif., January 8, 2014 – Ritter Pharmaceuticals, Inc. today announced that Nutrition Journal has published the results of its Phase 2 trial of RP-G28, a proprietary oligosaccharide under investigation as a potential treatment for lactose intolerance. The study manuscript entitled, “Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial” is the first peer-reviewed presentation of the protocol, assessments and results which showed that RP-G28 dramatically reduced the pain and symptoms of lactose intolerant patients.
Publication of this study marks a major milestone in lactose intolerance research, as it is the first well-controlled Phase 2 study for a prescription drug candidate for patients with lactose intolerance (LI). With planning underway to begin advanced clinical trials later this year, RP-G28 may become the first approved medical therapy for LI.
“The Nutrition Journal publication validates the work that has been done by our team to provide a meaningful new therapeutic approach to managing lactose intolerance symptoms, and helping millions of lactose intolerant people worldwide,” said Andrew Ritter, president and CEO of Ritter Pharmaceuticals, Inc. “The data gleaned from this study and our extensive research into colonic adaptation as a means of treating gastrointestinal disorders are being incorporated into the design of an advanced clinical program for RP-G28,” he added.
According to the publication’s results, a majority of the lactose intolerant patients who began the study with abdominal pain associated with dairy consumption reported no abdominal pain after taking RP-G28 and their symptom relief was sustained for at least one month thereafter, which is a statistically significant result. Likewise, the patients who received the study drug, compared to the ones who received placebo, were 6 times more likely to claim that, following treatment, they could consume dairy products free of lactose intolerance symptoms. See Nutrition Journal, December 13, 2013, Research section (http://www.nutritionj.com/content/12/1/160 ).
The randomized, double-blind, parallel group, placebo-controlled Phase 2 study was conducted at two sites in the United States. RP-G28 or placebo was administered daily to 85 patients with lactose intolerance for 35 consecutive days. Post-treatment, subjects reintroduced dairy into their diets and were followed for an additional 30 days to evaluate lactose digestion, as measured by hydrogen production, and symptom improvements, via a patient-reported symptom assessment instrument.
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 is the world leader in developing novel therapeutics aimed at modulating the human microbiome to treat inflammatory, gastrointestinal and metabolic diseases. Ritter Pharma’s lead compound, RP-G28, is currently under development for the treatment of lactose intolerance (LI). Ritter Pharma’s RP-G28 is the first investigational drug candidate to complete a Phase 2 clinical study as a potential medical therapy for patients with lactose intolerance. Advanced clinical studies of RP-G28 for LI and other gastrointestinal indications are being planned.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the clinical development of Ritter’s drug candidate, RP-G28, and RP-G28′s potential to treat the symptoms associated with lactose intolerance. Words such as “intended”, “potential” and similar words and expressions identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Ritter that any of its plans will be achieved. Future results can be affected by inaccurate assumptions and by known or unknown risks and uncertainties. For example, statements relating to Ritter’s ongoing clinical trials may turn out to be wrong because, among other things, Ritter’s product candidates may prove to be ineffective and planned studies could be delayed as a result of actions by third parties upon whom Ritter relies or Ritter’s own lack of financial resources. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Ritter undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.