BOSTON, Oct. 2, 2020 /PRNewswire-PRWeb/ — DermBiont, Inc., a clinical stage biotechnology company targeting skin diseases at their root cause, announced today that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for DBI-001 in a phase 2b clinical trial in atopic dermatitis in the United States.
DBI-001 is a live bacterial therapeutic candidate in DermBiont’s extensive biotherapeutics pipeline. Clinical trials outside of the United States with the same product were recently completed in a phase 2a atopic dermatitis trial and results will be released in early October.
“It is exciting for our company to reach this important regulatory milestone,” said Dr. Sanjay Jain, Chief Development Officer and head of CMC. “We are eager to expand our clinical development in atopic dermatitis, treating subjects with the intent to rebalance their microbiome to a symbiotic state with a live bacterial therapeutic that is formulated and manufactured in-house.”
“DermBiont continues to build on the successes of our earlier trials, as well as expand our manufacturing capabilities,” Dr. Karl Beutner, Co-Founder, Chief Executive Officer, and Chief Medical Officer added. “Atopic dermatitis is a challenging illness for millions of adults and children throughout the world, and it is important that we work to find treatments to improve these individuals’ lives.”
DermBiont is the world’s leading dermatology company leveraging skin microbiome therapeutics (live biotherapeutics) to treat the root cause of skin diseases. In addition to the company’s lead product in development to treat Onychomycosis and Atopic Dermatitis, DBI-001, the company is advancing four other clinical assets across a wide range of skin diseases caused by a dysbiosis of the microbiome. The company’s discovery capabilities are powered by a proprietary computational biology platform enabling the rapid discovery of hits against pathogens from a curated library of thousands of microbes isolated from human skin and one of the world’s largest data sets of Nextgen sequencing of the human microbiome across healthy and diseased skin.
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SOURCE DermBiont, Inc.