$RTTR Halted and resumed after hours yesterday.
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Posted On: 03/29/2017 5:33:40 AM
$RTTR Halted and resumed after hours yesterday.
04:28 AM EDT, 03/29/2017 (MT Newswires) -- Ritter Pharma said late Tuesday that a study of RP-G28, which is being developed for the treatment of lactose intolerance, met the endpoint, was effective and showed "clinically meaningful" benefit in a phase 2b/3 study.
The company has requested an end-of-phase 2 meeting with the U.S. Food and Drug Administration, as it believes the successful completion of a confirmatory phase 3 program could be adequate to support a new drug application submission.
LOS ANGELES, CA -- (Marketwired) -- 03/28/17 -- Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR)
Data Supports Further Clinical Development into Phase 3
Conference call and webcast at 9 a.m. EDT , March 29, 2017
Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company"
today announced topline findings from its Phase 2b/3 study designed to evaluate RP-G28 in subjects with lactose intolerance. Results from the 377-subject trial show a clinically meaningful benefit to subjects in the reduction of lactose intolerance symptoms across a variety of outcome measures. The majority of analyses showed positive outcome measures and the robustness of the data point to a clear drug effect. Based on these trial results, the Company believes that the successful completion of a confirmatory Phase 3 program could be adequate to support a New Drug Application (NDA) submission and therefore has requested an end-of-Phase 2 meeting with the U.S. Food and Drug Administration ( FDA ).
About the Trial and RP-G28
04:28 AM EDT, 03/29/2017 (MT Newswires) -- Ritter Pharma said late Tuesday that a study of RP-G28, which is being developed for the treatment of lactose intolerance, met the endpoint, was effective and showed "clinically meaningful" benefit in a phase 2b/3 study.
The company has requested an end-of-phase 2 meeting with the U.S. Food and Drug Administration, as it believes the successful completion of a confirmatory phase 3 program could be adequate to support a new drug application submission.
LOS ANGELES, CA -- (Marketwired) -- 03/28/17 -- Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR)
Data Supports Further Clinical Development into Phase 3
Conference call and webcast at 9 a.m. EDT , March 29, 2017
Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (the "Company"
today announced topline findings from its Phase 2b/3 study designed to evaluate RP-G28 in subjects with lactose intolerance. Results from the 377-subject trial show a clinically meaningful benefit to subjects in the reduction of lactose intolerance symptoms across a variety of outcome measures. The majority of analyses showed positive outcome measures and the robustness of the data point to a clear drug effect. Based on these trial results, the Company believes that the successful completion of a confirmatory Phase 3 program could be adequate to support a New Drug Application (NDA) submission and therefore has requested an end-of-Phase 2 meeting with the U.S. Food and Drug Administration ( FDA ). About the Trial and RP-G28
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