Corporate News Blog - Ritter Pharma Announces Phase-3 Plans After End of Phase-2 Meeting with the FDA on RP-G28 for Lactose Intolerance
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LONDON, UK / ACCESSWIRE / August 22, 2017 /Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=RTTR. The Company announced on August 18, 2017, its Phase-3 plans following the end of Phase-2 meeting with the US Food and Drug Administration (FDA) concerning the path forward for RP-G28 for the treatment of lactose intolerance (LI). The Company has incorporated guidance from the FDA on key elements of its Phase-3 program and received clear guidance and expectations on necessary components, including clinical, nonclinical, and chemistry, manufacturing and controls requirements necessary to support a successful new drug application (NDA) submission. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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The Meeting Highlights
Under terms of the announcement, Ritter Pharma announced that the Phase-3 clinical program will consist of two confirmatory clinical trials of similar trial design and size as the Company's Phase-2b/3 trial and will include additional components to allow for claims for durability of effect. The trials, according to the Company may run in parallel, where it anticipates initiating the Phase-3 program during the first half of 2018.
The protocol design, according to the announcement, will consist of multicenter, randomized, double-blind, placebo-controlled, parallel-group trials designed to determine the efficacy, safety, and durability of RP-G28 compared against placebo in subjects with lactose intolerance. The protocol design also includes screening to determine lactose intolerance, 30-day course of treatment, and 6-months of post-treatment observation. The primary endpoint will be the evaluation of a patient's composite LI symptoms, after a lactose challenge, comparing baseline symptom scores to 30-days post-treatment symptom to assess patient's clinically meaningful benefit. The secondary endpoint will evaluate LI signs and symptom and global assessment outcomes to evaluate and assess a patient's continued meaningful treatment benefit.
The Phase-2b/3 Trial and the RP-G28
The Phase-2b/3, multicenter, double-blind, placebo-controlled, parallel-group trial in 377 subjects was designed to determine the efficacy, safety, and tolerability of two dosing regimens of RP-G28 in subjects with lactose intolerance. RP-G28 is in fact, a novel, non-digestible oligosaccharide of ultra-high purity developed to module the gut microbiome by stimulating and adapting the bacteria in the gastrointestinal tract to metabolize lactose to improve lactose tolerance.
Under the trial, patients were assessed with lactose intolerance symptoms, measured on a Likert scale after a lactose challenge. Symptoms of abdominal pain, cramping, bloating, and movement were then combined into a composite endpoint representing the key symptoms of lactose intolerance. The composite primary endpoint was agreed to by the FDA prior to the unblinding the study results. The Phase-2b/3 trial design included a screening phase, a 30-day course treatment phase and post-treatment observation phase, during which subjects were followed while lactose-containing foods were reintroduced in their diets.
On August 03, 2017, Ritter Pharma announced additional findings and data analysis from its Phase-2b/3 study designed to evaluate lead candidate RP-G28 in subjects with lactose intolerance. These additional results from the trial analysis demonstrated that a clear drug effect was seen with a significant positive reduction in key symptoms of lactose intolerance and across a variety of global and real-world outcomes. The study demonstrated safety with no serious adverse events related to treatment.
Last Close Stock Review
On Monday, August 21, 2017, the stock closed the trading session at $0.57, dropping 4.50% from its previous closing price of $0.60. A total volume of 168.37 thousand shares have exchanged hands. Ritter Pharma's stock price rallied 0.53% in the last one month. The stock currently has a market cap of $7.45 million.
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