FDA Digests Ritter Pharma's Phase II Microbiome Data
LOS ANGELES, CA--(Marketwired - April 12, 2017) - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company") today, April 12, 2017, announced that the U.S. Food and Drug Administration (FDA) has agreed to schedule an end of phase 2 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 2b/3 trial and phase 3 plans in preparation of a New Drug Application (NDA) submission of RP-G28 for the treatment of lactose intolerance. The completed phase 2b/3 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 2b/3 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.
- In consultation with the FDA(2), 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).
- No serious adverse events (SAEs) related to RP-G28 were reported in the study, further supporting the safety profile previously shown in the phase 2a study.
- The trial evaluated two different dosing strengths, generating the necessary data to help identify an optimal dose regimen of treatment effect.
Dr. William Chey, Director of the GI Physiology Laboratory at University of Michigan, commented, "The fact that the Company was able to develop a well-defined clinical outcomes instrument to quantify clinical meaningfulness in lactose intolerance patients is an important outcome of the trial and contribution to the field. We need to remember, there was no standard test to evaluate lactose intolerance symptoms prior to this study. Based on the topline results of the study, I believe this instrument performed well in defining and capturing clinical benefits to patients with lactose intolerance. I am encouraged to see consistency in the data outcome measures and believe that the topline results provide data supporting a treatment benefit of this investigational compound." Dr. Chey further noted, "Based upon these encouraging results, I believe a Phase 3 program can be well-defined and developed from here."
(1) Additional topline data results of the phase 2b/3 trial can be found at www.ritterpharmaceuticals.com/investors/events-presentations
(2) Ritter Pharmaceuticals held a Type C informational meeting with the FDA in March of 2017 prior to unblinding the phase 2b/3 clinical trial
End of Phase 2 Meeting & Phase 3 Program Plans
The end of phase 2 meeting will be an important venue to consult with the FDA on finalizing the Phase 3 clinical program and remaining NDA-enabling package necessary for obtaining commercial approval of RP-G28 for the treatment of lactose intolerance. The Company further plans to discuss many aspects of the phase 2b/3 trial results, including the use of the phase 2b/3 data as supportive for registration and the number of subjects expected in the remaining clinical program for a satisfactory NDA filing.
In preparation for the Phase 3 program, the Company has commenced manufacturing efforts and currently anticipates the initiation of phase 3 in the first half of 2018.
About Ritter Pharmaceuticals
Ritter Pharmaceuticals, Inc. (www.RitterPharma.com, @RitterPharma) develops novel therapeutic products that modulate the gut microbiome to treat gastrointestinal diseases. Its lead product, RP-G28, has the potential to become the first FDA-approved treatment for lactose intolerance, a condition that affects millions worldwide. The Company is further exploring the functionality and discovering the therapeutic potential gut microbiome changes may have on treating/preventing a variety of conditions including: gastrointestinal diseases, immuno-oncology, metabolic, and liver disease.
This release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our ability to successfully complete a confirmatory phase 3 program that will be adequate to support a NDA submission and to bring RP-G28 to market. Management believes that these forward-looking statements are reasonable as and when made. However, such statements involve a number of known and unknown risks and uncertainties that could cause the Company's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks that the FDA will not agree with our interpretation of the data results from our phase 2b/3 clinical trial and risks associated with the drug development process generally, including the outcomes of planned clinical trials and the regulatory review process. For a discussion of certain risks and uncertainties affecting Ritter Pharmaceuticals' forward-looking statements, please review the Company's reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management's current expectations and Ritter Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.