LOS ANGELES (May 2, 2017) – Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (“Ritter Pharmaceuticals” or the “Company”), a leading developer of novel therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases, today announced that it has been issued three new patents directed to its development compound RP-G28. The Company is also providing an update on its phase 3 program based on conversations with regulatory authorities and experts.
The Company has been issued two new U.S. patents and one new Australian patent. The two new U.S. patents (U.S. Patent Nos. 9,579,340 and 9,592,248) are directed to compositions containing RP-G28 and methods of using RP-G28, further strengthening the intellectual property positions of RP-G28. The issuance of an Australian patent (No. 20102184) provides additional international protection for compositions containing the compound.
“We are pleased to add these additional issued patents to our portfolio of issued and pending claims, providing both validation and protection for our compound, RP-G28, in development for the treatment of lactose intolerance” stated Michael Step, CEO of Ritter Pharmaceuticals. “We now have 15 issued patents and over 25 additional pending patent applications. This additional intellectual property continues to protect our compound and its uses, likely beyond 2030.”
In addition to the new intellectual property, the company has been working diligently on preparing for phase 3, having had preliminary discussions with its regulatory experts and the U.S. Food and Drug Administration (FDA). “We will be holding an end of phase 2 meeting with the FDA to present and discuss our phase 3 plan, for which we hope to receive guidance and agreement on what is expected before filing a new drug application (NDA) for commercializing RP-G28,” said Andrew Ritter, President and co-founder of Ritter Pharmaceuticals. “We believe that the completion of one well-powered phase 3 study with robust clinical results may be sufficient to successfully file this NDA. Based on our communication with the FDA, including our Type C meeting in March 2017 and subsequent communications, we feel we have established agreement with the FDA on defining clinically meaningful benefit to patients and have established endpoints that we feel are both achievable in the clinic and represent sufficient basis for an approval once completed. We will be discussing the final features of this trial and other relevant aspects of the program with the FDA at our upcoming meeting to ensure we have a product that meets regulatory goals in phase 3,” stated Andrew Ritter.
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.