MatriSys asks for meeting with FDA over anti-atopic dermatitis topical drug candidateJanuary 3, 2019
MatriSys Bioscience is waiting to meet with the US FDA to complete preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01, it said Wednesday.
In a press relesae, announcing a pre-IND (Investigational New Drug) meeting request letter to the U.S. Food and Drug Administration, the company has referred its CEO Mark S. Wilson as saying that this pre-IND meeting request marks an important regulatory milestone in advancing the development of MSB-01 for the treatment of moderate to severe atopic dermatitis.
He said: “Unlike the ongoing clinical trial (NCT03151148) at two US sites which is performed under a physician investigator-sponsored IND, this MatriSys Bioscience-sponsored IND is intended to initiate a Phase 2B study of MSB-01. This trial is planned to be a randomized double-blind, placebo-controlled safety, tolerability, and efficacy study of MSB-01 to treat atopic dermatitis in a total of 150 patients over a 12-week treatment period. The company will fund this pivotal trial with the goal to obtain definitive proof-of-concept clinical data for MSB-01.”
Wilson added that this pre-IND request initiates the process of establishing formal communication and discussion with the FDA regarding defining the critical path for clinical development and marketing approval of MSB-01 to help the millions of patients suffering from AD. He noted that the company is highly committed to moving this program forward as quickly as possible and, following IND approval, and that it plans to begin with the Phase 2 trial by mid-2019.
Atopic dermatitis (also known as atopic eczema) is an increasingly common and complex skin disease that leads to extreme dryness, itchiness and intense skin discomfort. The disease is a non-contagious, inflammatory skin condition that is characterized by itching, redness, and scaly rashes. Symptoms can be painful, cause skin coloring changes, blisters, and often appear on the arms, legs, hands, and face. The itch associated with eczema can be severe, often interrupting sleep. AD continues to increase in prevalence, and now affects 15–30% of children and 2–10% of adults in developed countries.
In addition to the IND filing, MatriSys Bioscience stressed its pursue of a robust intellectual property portfolio related to its groundbreaking technology. In the past year, two patents have issued based on MatriSys’ licensed technology, the company noted in its press release. “Additionally, we have filed a provisional patent application covering shelf-stable formulations for MSB-01 and related products. Further IP filings related to novel manufacturing methods, additional compositions, and new indications are planned for early 2019,” the company’s announcement read.