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.
RP-G28’s 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.
Howard Foyt, executive vice-president and chief medical officer of Ritter Pharmaceuticals, said: “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.”