LOS ANGELES, CA, USA I August 15, 2016 I Ritter Pharmaceuticals, Inc. ( NASDAQ : RTTR ) (“Ritter Pharmaceuticals” or the “Company”), a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced that it has completed patient enrollment on schedule for its Phase 2b/3 clinical trial of its investigational compound RP-G28 for the treatment of lactose intolerance. Topline results of the trial are expected to be announced in the first quarter of 2017.
The Phase 2b/3 trial is a double-blind, placebo-controlled, three arm, multicenter study evaluating safety, efficacy and tolerability of two dosing regimens of its investigational compound RP-G28 in patients with moderate to severe lactose intolerance symptoms. Enrollment was initiated in March of 2016 and completed within 6-months, achieving the company’s projected enrollment milestones. The study aims to evaluate a patient’s ability to consume dairy foods post-treatment with improved tolerance and reduced digestive symptoms. A total of 377 subjects were enrolled in the trial with 18 clinical sites participating throughout the United States. Patients undergo a 30-day treatment, followed by a 30-day post-treatment evaluation of dairy tolerance1. In addition, the study will evaluate each participant’s microbiome, expanding knowledge of the effects that RP-G28 may have on adapting the gut microbiota in a beneficial manner.
Dennis Savaiano, Ph.D., Professor of Nutrition Science at Purdue University and Chairman of Ritter Pharmaceuticals’ medical advisory board, further stated, “The rapid speed of recruitment and sheer number of patients requesting participation in the trial demonstrates that lactose intolerant individuals are actively seeking options to treat embarrassing and often painful symptoms associated with this condition.
William Sandborn, M.D., Chief and Professor, Division of Gastroenterology and Director at UCSD Inflammatory Bowel Disease Center, further added, “It is exciting to see rapid progress in a large human clinical study involving the microbiome in a GI condition. We feel the knowledge gained from exploring our study’s microbiome data could be beneficial in a number of diseases.”
Andrew J. Ritter, Founder and President of Ritter Pharmaceuticals, added, “We are delighted to have successfully met our enrollment target on schedule. I would like to recognize our clinical sites for their hard work and diligence in helping us achieve our goals. Completion of enrollment marks an important milestone in our pursuit of the first FDA-approved treatment for lactose intolerance which may help the over 60 million Americans and globally millions more who suffer from this condition.”
1 Additional information on the study is available at: https://clinicaltrials.gov/ct2/show/NCT02673749?term=lactose+intolerance&rank=6
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human 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. Their 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.
SOURCE: Ritter Pharmaceuticals
Post Views: 24
LOS ANGELES, CA, USA I August 15, 2016 I Ritter Pharmaceuticals, Inc. ( NASDAQ : RTTR ) (“Ritter Pharmaceuticals” or the “Company”), a pharmaceutical company developing novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced that it has completed patient enrollment on schedule for its Phase 2b/3 clinical trial of its investigational compound RP-G28 for the treatment of lactose intolerance. Topline results of the trial are expected to be announced in the first quarter of 2017.
The Phase 2b/3 trial is a double-blind, placebo-controlled, three arm, multicenter study evaluating safety, efficacy and tolerability of two dosing regimens of its investigational compound RP-G28 in patients with moderate to severe lactose intolerance symptoms. Enrollment was initiated in March of 2016 and completed within 6-months, achieving the company’s projected enrollment milestones. The study aims to evaluate a patient’s ability to consume dairy foods post-treatment with improved tolerance and reduced digestive symptoms. A total of 377 subjects were enrolled in the trial with 18 clinical sites participating throughout the United States. Patients undergo a 30-day treatment, followed by a 30-day post-treatment evaluation of dairy tolerance1. In addition, the study will evaluate each participant’s microbiome, expanding knowledge of the effects that RP-G28 may have on adapting the gut microbiota in a beneficial manner.
Dennis Savaiano, Ph.D., Professor of Nutrition Science at Purdue University and Chairman of Ritter Pharmaceuticals’ medical advisory board, further stated, “The rapid speed of recruitment and sheer number of patients requesting participation in the trial demonstrates that lactose intolerant individuals are actively seeking options to treat embarrassing and often painful symptoms associated with this condition.
William Sandborn, M.D., Chief and Professor, Division of Gastroenterology and Director at UCSD Inflammatory Bowel Disease Center, further added, “It is exciting to see rapid progress in a large human clinical study involving the microbiome in a GI condition. We feel the knowledge gained from exploring our study’s microbiome data could be beneficial in a number of diseases.”
Andrew J. Ritter, Founder and President of Ritter Pharmaceuticals, added, “We are delighted to have successfully met our enrollment target on schedule. I would like to recognize our clinical sites for their hard work and diligence in helping us achieve our goals. Completion of enrollment marks an important milestone in our pursuit of the first FDA-approved treatment for lactose intolerance which may help the over 60 million Americans and globally millions more who suffer from this condition.”
1 Additional information on the study is available at: https://clinicaltrials.gov/ct2/show/NCT02673749?term=lactose+intolerance&rank=6
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. develops novel therapeutic products that modulate the human 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. Their 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.
SOURCE: Ritter Pharmaceuticals
Post Views: 24
