Medsenic Receives Positive Pre-IND Response from FDA to Initiate a Phase III Clinical Study in cGvHD

June 21, 2022 |

2 min read

Medsenic announced the positive conclusions of the pre-IND meeting with the US Food and Drug Administration.

STRASBOURG, France--(BUSINESS WIRE)-- Medsenic, a clinical-stage biopharmaceutical company focusing on the discovery and development of new indications and formulations of arsenic salts for the treatment of severe autoimmune diseases, announced today the positive conclusions of the pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA).

Medsenic’s proposed protocol with OATO (oral arsenic trioxide) was received favorably by the FDA. Following the implementation of a few improvements suggested by the agency, the protocol can be submitted as an IND application for our Phase III clinical study in chronic graft versus host disease (cGvHD).

This feedback from the FDA is based on the positive results of the Phase II clinical study GMED16-001 with Arscimed® IV. The primary endpoint of this prospective, multicenter, non-randomized study was the improvement of treatment response with Arscimed® in combination with prednisone, with or without cyclosporine. Complete or partial disease remission was obtained 6 months after GvHD diagnosis and maintained at 12 months.

Medsenic is focusing its clinical activities on the development of OATO (oral arsenic trioxide) for the treatment of selected autoimmune diseases.

Consequently, preparations for the Phase III study are progressing as planned, with a launch expected early 2023. This randomized, double-blind, placebo-controlled Phase III study will assess the efficacy and safety of oral arsenic trioxide (OATO) as first-line treatment for cGvHD.

Prof. François Rieger, President and co-founder of Medsenic, said: “We are pleased with the promising pre-IND response from the FDA. This is a very important step towards a clinical application of our OATO drug candidate for the treatment of cGvHD. An interim analysis is planned halfway through our Phase III study, and if positive, these first results will help us plan for an accelerated approval for the oral drug.”

The convenient administration and increased safety of this oral formulation constitute a major advance in the treatment of autoimmune diseases with so far unmet medical needs.

About Medsenic: https://www.medsenic.com/