LOS ANGELES, CA--(Marketwire - June 07, 2010) -
Ritter Pharmaceuticals, Inc. (Ritter), a pharmaceutical company with a focus on digestive diseases, announced that the United States Food and Drug Administration (FDA) has approved the Company´s Investigational New Drug (IND) application for RP-G28, a novel therapeutic product for the treatment of lactose intolerance. RP-G28 has the potential to become the first FDA-approved drug treatment for lactose intolerance, which affects more than 58 million people in the United States and 4.3 billion people worldwide. With IND approval, Ritter is permitted to initiate a Phase IIa clinical trial of RP-G28, directly assessing its safety, tolerability and effectiveness in humans.
Lactose intolerance is the onset of gastrointestinal symptoms from the consumption of lactose, a sugar found in dairy products. Symptoms associated with lactose intolerance include gas, cramps, bloating, and diarrhea. This disorder can also increase one's long-term health risk for developing osteoporosis, colon cancer, breast cancer or hypertension.
RP-G28's IND acceptance marks an important milestone for Ritter. The IND approval confirms that the preclinical safety and toxicology package is sufficient to allow initiation of clinical trials in humans, and it provides external validation of Ritter's overall development program, which includes bypassing the traditional Phase I trials and proceeding directly with a Phase IIa proof-of-concept study.
Andrew Ritter, President & CEO of Ritter Pharmaceuticals, highlights, "We are extremely pleased with FDA's approval of RP-G28's IND, which is a clear endorsement of the quality of our preclinical data package and development plan. Lactose intolerance is an extremely significant condition suffered by millions of people, with few reliable treatments currently available. A therapeutic product in this area has enormous commercial potential."
Dr. Howard Foyt, Executive Vice-President and Chief Medical Officer of Ritter Pharmaceuticals, added, "We appreciate the acceptance by the FDA of our development plan and their recognition of RP-G28's overall safety. We now have a clear path to conduct our clinical trials."
About Ritter Pharmaceuticals
Ritter is committed to the discovery, development and commercialization of innovative therapies for gastrointestinal diseases. The Company's scientific platform of gastrointestinal physiology, metabolism and gut adaptation brings creativity to providing unique therapeutic approaches to a variety of GI diseases, including lactose intolerance, irritable bowel syndrome, Crohn's disease, and ulcerative colitis.