Ritter Pharmaceuticals, Inc schedules FDA meeting to plan Phase III programme for RP-G28 for the treatment of lactose intolerance.

Ritter Pharmaceuticals, Inc. announced that the FDA has agreed to schedule an end of phase II meeting with the company which is expected to take place in the third quarter of 2017. The Company plans to discuss the results of its recently completed phase IIb/III trial and phase III plans in preparation of a New Drug Application (NDA) submission of RP-G28 for the treatment of lactose intolerance. The completed phase IIb/III trial demonstrated several positive topline results and full analysis of the data is underway. The trial was the largest well-controlled clinical study ever conducted in lactose intolerance.

Topline phase IIb/III trial results provide several positive outcomes: 1. RP-G28 showed a clinically meaningful beneficial effect on patients in both symptom reduction and global patient assessments of benefit. 2.In consultation with the FDA, a composite symptom score was considered appropriate for the primary endpoint. The trial�s associated outcomes data support the primary endpoint as an appropriate measurement tool to evaluate and quantify clinically meaningful patient benefit (as defined as a composite symptom reduction of abdominal pain, abdominal cramping, abdominal bloating, and abdominal gas). 3. No serious adverse events (SAEs) related to RP-G28 were reported in the study, further supporting the safety profile previously shown in the phase IIa study. The trial evaluated two different dosing strengths, generating the necessary data to help identify an optimal dose regimen of treatment effect.

Comment: RP-G28 has the potential to become the first FDA approved drug for the treatment of lactose intolerance, a debilitating disease that affects over one billion people worldwide. RP-G28 effectively stands out as the only therapeutic regimen impacting the natural history of the disease, alleviating the symptoms and reducing the frequency of symptomatic episodes of lactose intolerance. The product stimulates the growth of lactose-metabolizing bacteria in the colon, which reduces lactose-derived gas production, and thereby mitigates the symptoms of lactose intolerance in the process.