MatriSys Bioscience announces successful FDA Pre-IND review and Phase 2 plans for MSB-01, a revolutionary human-microbiome based treatment for Atopic Dermatitis
SAN DIEGO, March 20, 2019 (GLOBE NEWSWIRE) -- MatriSys Bioscience, Inc., a clinical stage biotechnology company developing rationally designed microbiome therapeutics to treat the top five skin diseases, today announced it has successfully completed a pre-IND (Investigational New Drug) review with the U.S. Food and Drug Administration (FDA). The FDA provided positive feedback regarding the 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). An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans.
“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. “We appreciate the FDA’s guidance as we pursue our mission of bringing a novel and effective treatment to the 18 million Americans suffering with AD.” 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.
Atopic Dermatitis is a chronic inflammatory skin disease which poses a significant burden on patients’ quality of life. AD affects up to 30% of children and up to 3% of adults and those numbers continue to increase worldwide. Compared to healthy individuals, subjects with AD have a lower bacterial diversity that translates to an inability to resist colonization by the pathogen Staphylococcus aureus. MSB-01 is a proprietary topical bacterial formulation containing a stabilized lyophilized topical preparation of Staphylococcus hominis, universal strain A9 (Sh-A9). The topical formulation is applied to the skin of patients, and the lyophilized bacteria Sh-A9 return to an active state and kill Staph. aureus. This approach is a dramatic improvement over broad-spectrum antibiotics that destroy pathogenic bacteria but also kill beneficial bacteria by “friendly fire”.
About MatriSys Bioscience
MatriSys Bioscience, Inc. is a clinical stage Specialty Biopharmaceutical Company focused on developing and commercializing rational microbiome therapies for the top five dermatology and skin care conditions. MatriSys’ foundational microbiome therapeutics platform is based on the pioneering work of Richard L. Gallo MD PhD, Distinguished Professor and Founding Chair, Department of Dermatology, University of California, San Diego.
Mark Wilson+1 (858) 752-9003