LOS ANGELES, CA--(Marketwired - Jun 12, 2013) - Ritter Pharmaceuticals announced that data from its Phase 2 clinical study of RP-G28 in patients with lactose intolerance demonstrated the agent's ability to alter the composition of microbes in patients' intestines. The work was presented at the New York Academy of Sciences Conference on Probiotics, Prebiotics and the Host Microbiome: The Science of Translation, held today and co-sponsored by the Sackler Institute for Nutrition Science and the International Scientific Association for Probiotics and Prebiotics.
The results indicate that RP-G28, being developed by Ritter Pharmaceuticals, significantly altered the microbiomes of 82% of the study participants who received the treatment. Results from the Phase 2 study also showed that 6 times as many patients in the treatment group, versus the placebo group reported lactose tolerance, defined as the ability to consume dairy products without symptoms, at completion of the treatment cycle.
Todd Klaenhammer, Ph.D., Distinguished University Professor at North Carolina State University, presented today's research, which was compiled based on state-of-the-art microbiome analyses of study subjects' stool samples analyzed before treatment, following treatment and 30 days post-treatment. The study was a multidisciplinary effort between Purdue University (Clinical), NC State University and the University of North Carolina, at Chapel Hill (microbiology and microbiome analysis). Dr. Klaenhammer told the conference audience that "these data suggest that diet-induced beneficial changes in the microbiome may improve a person's tolerance to lactose."
Andrew J. Ritter, president and CEO of Ritter Pharmaceuticals, Inc., said that the implications for these groundbreaking findings "suggest that RP-G28 may also prove useful in treating other GI conditions, such as inflammatory bowel disease." He pointed out that the research presented today is "the first to definitively show that altering the microflora in humans' intestines is possible and measurable in a set population, and has the potential to offer health benefits."
Phase 2 Study of RP-G28 for Lactose Intolerance
The double-blinded, randomized, multi-center, placebo-controlled Phase 2 study 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. Changes in the fecal microbiome were investigated using both Terminal Restriction Fragment Length polymorphisms (TRFLP) and microbiome analysis of 16S rRNA genes by pyrosequencing. The patients in the RP-G28 treatment group had a statistically significant decrease in the typical symptoms of lactose intolerance symptoms, including reduction in abdominal pain, cramping, bloating and flatulence at day 36. The reduction in total symptoms was consistent with the improvement in hydrogen breath test results following post-treatment lactose challenge as compared to baseline (pre-treatment) results. RP-G28 was well tolerated with no significant study-drug related adverse events. RP-G28 appears to be an effective strategy for improving lactose digestion and reducing lactose intolerance symptoms in lactose intolerant subjects. Ritter Pharmaceuticals expects to report the complete results from this Phase 2 clinical study in a peer-reviewed journal.
Ritter is a specialty pharmaceutical company developing therapeutics based upon the microbiome and 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 lactose intolerant patients.
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.