Ritter Pharmaceuticals, Inc. Phase 2a Lactose Intolerance Clinical Trial Microbiome Data, Published In PNAS
LOS ANGELES, CA--(Marketwired - January 03, 2017) - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) ("Ritter Pharmaceuticals" or the "Company"), a developer of novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced that clinical microbiome data from its Phase 2a clinical trial of RP-G28 in patients with lactose intolerance were published in the Proceedings of the National Academy of Science ("PNAS-Plus") PNAS 2017; Early Edition, published ahead of print January 3, 2017.(1)
The paper titled, "Impact of short-chain galactooligosaccharides on the gut microbiome of lactose-intolerant individuals," reports findings on the Company's lead therapeutic candidate, RP-G28, a short-chain galactooligosaccharide ("GOS"). The data validates RP-G28's mechanism of action and supports the product as a potential treatment for lactose intolerance. The newly published microbiome data provides further insight into RP-G28's Phase 2a 2013 clinical trial(2), which has lead to a Phase 2b/3 377-subject clinical trial (results expected in 2017).
The results of the study demonstrated that RP-G28 significantly modulated the gut microbiome composition of lactose intolerant individuals. Significant changes in the diversity of the microbiota occurred in GOS/RP-G28 treated subjects upon reintroduction of dairy into the diet. Key bacterial taxa changes included increases in lactose-fermenting Bifidobacterium, Lactobacillus and Faecalibacterium, and those changes correlated with a symptomatic improvement in tolerance to lactose (the sugar present in dairy foods). Notably, 90% of the RP-G28 treatment group showed a bifidogenic response compared to other GOS studies, which reported a bifidogenic response in 50% of the treated subjects.(3)
The study was a multi-center, randomized, double-blinded, placebo-controlled Phase 2a trial to evaluate whether a shift occurred in the fecal microbiome of lactose-intolerant human subjects who were treated with RP-G28 and a dairy diet and who exhibited a clinical response toward lactose tolerance. The study evaluated a patient's ability to consume dairy foods after first feeding RP-G28 for 35 days, followed by 30 days of introducing dairy products into the diet. A total of 85 subjects were enrolled in the trial with 57 randomized to receive RP-G28 and 28 in the placebo group. Andrea Azcarate-Peril, PhD, from the Department of Medicine, and Director of the Microbiome Core Facility, School of Medicine, University of North Carolina, Chapel Hill ("UNC") and Distinguished University Professor, Todd Klaenhammer, PhD, from the Department of Food, Bioprocessing & Nutrition Sciences, North Carolina State University, Raleigh, NC ("NCSU") conducted the analysis.
The microbiome analysis also uncovered other potentially health-promoting bacteria, specifically Faecalibacterium, that were enhanced by feeding RP-G28. This suggests that RP-G28 might have potential therapeutic benefits in inflammatory bowel disease and metabolic syndrome, among other diseases.
"Demonstrating that RP-G28 can increase key lactose-fermenting bacteria associated with symptom improvements sheds light on potential mechanisms of action for treating lactose intolerance," said Andrew J. Ritter, President of Ritter Pharmaceuticals. "The results of this analysis are consistent with our hypothesis of how the therapeutic may work and increases our confidence that it will be an effective option for patients seeking solutions for their lactose intolerance."
Dr. Andrea Azcarate-Peril added, "This is a seminal study producing some of the first data in lactose intolerance showing the microbiome's role in being able to metabolize lactose independent of host enzymes. Furthermore, it's remarkable that we observed a definitive shift to being lactose tolerant after a single 35-day dosing of RP-G28."
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. The Company is advancing human gut health research by exploring the metabolic capacity of gut microbiota, and translating the functionality of these microbiome modulators into safe and effective applications. The Company's lead drug candidate, RP-G28, has the potential to become the first FDA-approved drug for lactose intolerance, a condition that affects more than one billion people worldwide.
This release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our Phase 2b/3 results and clinical development of RP-G28. Management believes that these forward-looking statements are reasonable as and when made. However, such statements involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process. For a discussion of certain risks and uncertainties affecting Ritter Pharmaceuticals' forward-looking statements, please review the Company's reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2015 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2016, June 30, 2016 and September 30, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Ritter Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.
(2) Phase 2a Nutrition Journal Article: Savaiano et al.: Improving lactose digestion and symptoms of lactose intolerance with a novel galacto-oligosaccharide (RP-G28): a randomized, double-blind clinical trial. Nutrition Journal 2013 12:160.
(3) Hutkins: Davis LMG, Martınez I, Walter J, Goin C, Hutkins RW (2011) Barcoded Pyrosequencing Reveals That Consumption of Galactooligosaccharides Results in a Highly Specific Bifidogenic Response in Humans. PLoS ONE 6(9): e25200. doi:10.1371/journal.pone.0025200