Ritter Pharma has plan development meet with FDA
Ritter Pharma (NASDAQ: RTTR) disclosed in an SEC filing:
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 Company’s 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 Company’s 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 FDA’s 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 FDA’s recent recommendations.