MatriSys Bioscience got positive feedback from the FDA on its planned initiation of clinical trials for MSB-01 under a U.S. IND for MatriSys’ lead microbiome-based candidate, MSB-01, for the treatment of Atopic Dermatitis (AD).
“The positive feedback received from the FDA is encouraging and paves the way for submission of an IND application to the FDA and a Phase 2 trial for Atopic Dermatitis,” said Mark S. Wilson, MatriSys Bioscience Chief Executive Officer.
MatriSys plans to conduct a Phase 2 clinical trial with 150 patients over a 12-week treatment period. The trial will include a randomized double-blind, placebo-controlled safety, tolerability, and efficacy study using MSB-01 to treat atopic dermatitis, it said in a statement.