DermBiont Announces Positive Data from Phase 2a Clinical Trial and Start of Phase 2b Clinical Trial for Athlete's Foot with a Topical Live Biotherapeutic
DermBiont, a clinical stage microbiome biotechnology company developing topical live biotherapeutics, has announced that its lead program, DBI-001, met its primary safety endpoints, with no application site reactions and no adverse events, in a 12 person open labeled phase 2a clinical trial for the treatment of interdigital tinea pedis (athlete's foot). Additionally, the trial demonstrated a clinical response with improvement in the signs and symptoms of tinea pedis and demonstrated a reduction in the abundance of Trichophyton rubrum.
BOSTON, Oct. 22, 2019 /PRNewswire-PRWeb/ -- DermBiont, a clinical stage microbiome biotechnology company developing topical live biotherapeutics, has announced that its lead program, DBI-001, met its primary safety endpoints, with no application site reactions and no adverse events, in a 12 person open labeled phase 2a clinical trial for the treatment of interdigital tinea pedis (athlete's foot). Additionally, the trial demonstrated a clinical response with improvement in the signs and symptoms of tinea pedis and demonstrated a reduction in the abundance of Trichophyton rubrum.
Based on the results of the completed phase 2a trial, the company has started enrolling patients in a phase 2b clinical trial, which is a double-blind placebo-controlled study for the treatment of interdigital tenia pedis. The company will also be initiating a clinical trial in onychomycosis in early 2020.
In addition to addressing tinea pedis, DermBiont's lead candidate, DBI-001, is being evaluated for additional indications related to bacterial infection of the skin. In-vitro, DBI-001 has activity against fungi as well as bacteria. "This was DermBiont's first clinical trial, and it is rewarding to have met our goals for the study and enabled additional clinical trials. Although primarily designed as a safety study, our team is excited to see signs of a therapeutic response from a single dose of our product," said Dr. Karl Beutner, CEO of DermBiont.
"We continue to be pleased with the progress of our lead program along with other ongoing discovery and clinical efforts," added Dr. Robert Brucker, the company's CSO.
Approximately 15-25% of individuals globally are afflicted with athlete's foot and about 70% of the global population will suffer from athlete's foot at least once. There is an unmet clinical need for a therapeutic treatment that addresses the root cause of athlete's foot, a dysbiosis of the microbiome, and cures this otherwise chronic and recurrent condition. With the success of its ongoing program, DermBiont plans to commercialize the first FDA approved topical live biotherapeutic to treat skin disease.
About DermBiont
DermBiont is a dermatology company leveraging skin microbiome therapeutics to treat the root cause of skin diseases. In addition to advancing DBI-001, the company has a discovery platform based on a 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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http://www.dermbiont.com
SOURCE DermBiont, Inc.
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