DermBiont Announces Positive Results from Phase 2b Clinical Trial in Tinea Pedis
Analysis shows that DBI-001 reduces the abundance of T. rubrum the pathogen most commonly associated with athlete's foot. Application of DBI-001 also demonstrated a beneficial effect on the microbial community of organisms. Based on this result, along with positive data also announced today from a Phase 2a clinical trial in atopic dermatitis, DermBiont looks to usher in a new era in which common skin diseases are targeted at the source.
BOSTON, Jan. 8, 2021 /PRNewswire-PRWeb/ -- DermBiont, a clinical-stage biotechnology company developing targeted topical therapeutics, announced today that its phase 2b clinical trial with its investigational drug product, DBI-001, for the treatment of tinea pedis resulted in statistically significant decreases in the abundance in T. rubrum, statistically significant improvement in the signs and symptoms of tinea pedis, statistically significant improvement in the investigator static global assessment, beneficial changes in the microbial community, and no safety or tolerability issues.
"This trial was a successful outcome for DermBiont," said Dr. Karl Beutner, a co-founder and CEO. "We have demonstrated the clinical efficacy of DBI-001 in tinea pedis and have significantly deepened our industry leading understanding of the skin microbiome and how to develop live biotherapeutics as drug products."
This positive data builds upon earlier positive phase 2a results and supports the ongoing development and advancement of DBI-001 for the treatment of tinea pedis (athlete's foot) and onychomycosis (toenail fungus). Phase 2 trials are planned to commence in Q2 2020 for both indications.
The phase 2b double blind placebo-controlled trial follows DermBiont's phase 2a trial with DBI-001 for the treatment of tinea pedis. The phase 2a trial entailed a single application of drug product to patients' feet while phase 2b trial patients self-applied DBI-001 to their feet once daily for 28 days.
Analysis from the trial shows that DBI-001 not only reduces the abundance of T. rubrum (the pathogen most commonly associated with tinea pedis), but that the application of DBI-001 also has a beneficial effect on the skin's microbial community of organisms, adding to the evidence that tinea pedis is in fact a dysbiosis of the microbial ecology beyond a single organism (T. rubrum). The application of DBI-001 positively shifts the microbial ecology of the human skin at treated sites, leading to a positive state of symbiosis in patients' skin microbiome.
"DermBiont was founded to lead the field of evidence-based dermatology therapeutics that treat diseases at their root cause," said Nichola Eliovits, a co-founder and CBO. "Our unique and industry leading position within the field of the skin microbiome continues to advance with the success of this program and the expansion of our understanding of the microbiome. Importantly, this trial has also provided DermBiont with a number of unexpected discoveries that extend beyond our public disclosures and provide us with a number of competitive advantages across our entire biotherapeutics pipeline."
About DermBiont
DermBiont's mission is to become the world's leading precision dermatology company developing targeted topical therapeutics that treat, cure and prevent diseases. The company aims to impact the root cause of skin diseases with biotherapeutics that repair an imbalance of the microbiome as well as through the development of targeted small molecule therapeutics with well-defined mechanisms of action. DermBiont's biotherapeutics discovery team leverages computational biology and a proprietary bioinformatics platform to identify clinically meaningful dysbiosis related to common skin diseases and mines a curated library of microbes to build a pipeline of products to treat identified dysbiosis across indications. For more information, please visit http://www.dermbiont.com.
Media Contact
Nichola Eliovits, DermBiont, 510-607-8155, [email protected]
SOURCE DermBiont
Share this article