RITTER PHARMACEUTICALS, INC. (NASDAQ:RTTR) Files An 8-K Regulation FD Disclosure
Item 7.01.
| Regulation FD Disclosure. |
| Item 8.01. | Other Events. |
On March 1, 2017, Ritter Pharmaceuticals, Inc. (the Company) held
a Type C informational meeting with the U.S. Food and Drug
Administration (the FDA) to discuss its development plans and its
current Phase 2b/3 clinical trial for the treatment of lactose
intolerance per earlier discussions with the FDA. The focus of
the meeting was to gain feedback about the Companys statistical
analysis plan (SAP) and to best position the SAP so that the
study may be considered a pivotal registration trial upon receipt
of positive results. This meeting was held prior to un-blinding
the Companys Phase 2b/3 data.
The meeting with the FDA was constructive, collaborative and
productively focused on best defining clinically meaningful
benefits to patients suffering from lactose intolerance and how
to reflect these benefits in endpoints. By addressing the FDAs
recent recommendations, the Company has chosen to modify aspects
of its SAP, including modifying its primary endpoint to combine
abdominal pain with relevant secondary endpoints to establish an
abdominal composite score (abdominal pain, abdominal cramping,
abdominal bloating and abdominal gas). The protocol design and
the assessment utilized to collect lactose intolerance symptoms
remain unchanged. The Company is moving forward to make these SAP
changes, un-blind the data and release top-line results from the
clinical trial in the coming weeks.
The Company believes these modifications will be better suited to
show clinical meaningfulness to patients and better support
product approval and labeling claims to address the FDAs recent
recommendations.
About RITTER PHARMACEUTICALS, INC. (NASDAQ:RTTR)
Ritter Pharmaceuticals, Inc. develops therapeutic products that modulate the human gut microbiome to treat gastrointestinal diseases. The Company’s segment is focusing on the development and commercialization of RP-G28. The Company conducts human gut health research by exploring metabolic capacity of the gut microbiota and translating the functionality of prebiotic-based therapeutics into applications intended to have impact on a patient’s health. The Company’s compound, RP-G28, is under development for the treatment of lactose intolerance. The Company has completed a Phase IIa clinical trial of its product candidate, RP-G28, an orally administered oligosaccharide. RP-G28 is designed to stimulate the growth of lactose-metabolizing bacteria in the colon. The Company has not generated any revenues. RITTER PHARMACEUTICALS, INC. (NASDAQ:RTTR) Recent Trading Information
RITTER PHARMACEUTICALS, INC. (NASDAQ:RTTR) closed its last trading session down -0.04 at 2.96 with 104,619 shares trading hands.