MatriSys Bioscience Announces Initiation of Corporate IND for its MSB-01 with the FDA and new Microbiome formulation IP filing
- Category: DNA RNA and Cells
- Published on Thursday, 03 January 2019 09:06
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SAN DIEGO, CA, USA I January 03, 2019 I MatriSys Bioscience, Inc., a leader in the field of microbiome-based therapeutics for the treatment of skin conditions, announced today that it has submitted a pre-IND (Investigational New Drug) meeting request letter to the U.S. Food and Drug Administration (FDA) to finalize preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01.
“We are pleased to announce this pre-IND meeting request as it marks an important regulatory milestone in advancing the development of MSB-01 for the treatment of moderate to severe atopic dermatitis,” commented Mark S. Wilson, CEO of MatriSys Bio. “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.” Mark Wilson added, “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. We are highly committed to moving this program forward as quickly as possible and, following IND approval, we plan to commence 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 continues to pursue a robust intellectual property portfolio related to its groundbreaking technology. In the past year, two patents have issued based on MatriSys' licensed technology. 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.
MatriSys Bioscience is currently developing MSB-01 which is a commercially viable room-temperature stable topical formulation of freeze-dried S. hominis Strain A9 bacteria for application to the lesional skin of AD patients. The lyophilized bacteria are revived in the presence of skin moisture and kill S. aureus that colonize the patients’ skin. MSB-01 entered Phase 2A in September 2017 (in a frozen formulation).
About MatriSys Bioscience
MatriSys Bioscience is a clinical stage Specialty Biopharmaceutical Company focused on developing and commercializing rational microbiome therapies for the top five dermatology and skin care conditions. Our foundational microbiome therapeutics platform is based on the pioneering work of Richard L. Gallo MD PhD, Distinguished Professor and Founding Chair, Department of Dermatology at the University of California, San Diego and the http://gallolab.ucsd.edu/. For more information, please visit http://www.matrisysbio.com/.
SOURCE: MatriSys Bioscience