Ritter Pharmaceuticals, Inc. Encouraged by Meeting With FDA
LOS ANGELES, CA--(Marketwire - March 20, 2013) - Ritter Pharmaceuticals today reported that it is preparing to move forward with the design and implementation of the next stage of clinical trials to advance the development of RP-G28, the first therapeutic agent aimed at treating Lactose Intolerance. Company representatives recently met with teams from the FDA to discuss the appropriate outcome measures and clinical development plans for evaluating RP-G28 in upcoming mid- and late-stage clinical studies.
According to Ritter's Chief Medical Officer, Larry Good, M.D., "The FDA provided us very helpful guidance on our clinical development plans. We now have a clear understanding of the FDA's expectations and our path forward with our investigational agent, RP-G28."
Ritter expects to begin advanced Phase 2 clinical trials in patients with Lactose Intolerance later this year.
Ritter is a specialty pharmaceutical company developing therapeutics based upon 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 may well be the first medical option available to LI patients some day.