DermBiont Begins Phase 2 Clinical Trial for Athlete's Foot with a Live Bacterial Topical Probiotic
BOSTON, March 13, 2019 /PRNewswire-PRWeb/ -- DermBiont, an early stage biopharmaceutical company dedicated to the discovery and development of live bacterial products for the treatment of skin diseases has initiated a clinical trial with its lead bacterial therapeutic DBI-001 for the treatment of athlete's foot (T. pedis). The trial will evaluate the safety and tolerability as well as microbiologic and clinical endpoints following the application of three different dosage levels. The results of this trial will enable the start of a second Phase 2 trial in 2019 designed to further define clinical proof of concept in patients with interdigital athlete's foot.
Athlete's foot is a common chronic recurrent problem world-wide affecting nearly 25% of the global population and is currently treated with a number of small molecule antifungal drugs most of which have complete clinical and microbiologic response rates of less than 50%.
"This is a major event for the company and is the first ever clinical trial of a microbiome based live bacterial product intended to treat a human fungal infection. We chose this approach based on our therapeutic premise that athlete's foot is a dysbiosis of the cutaneous microbiome of the feet that is best treated by re-balancing the skin microbiome," stated Karl R. Beutner M.D., Ph.D. Chief Executive Officer and Chief Medical Officer of DermBiont. "By starting this trial, we have met the company's goal to be in the clinic within one year of our initial convertible note seed financing."
"It is very gratifying to see an observation that I made while researching the global die off of amphibian populations lead to clinical trials in humans," stated Rob Brucker, Ph.D. DermBiont's Chief Scientific Officer. "With the advance of DBI-001 to the clinic our research efforts are now focused on advancing additional microbiome-based products to the clinic."
DBI-001 is composed of Janthinobacterium lividum (human derived strain) in an aqueous gel formulation. A single application of this live bacterium has been shown in two independent laboratories in three species of amphibians to treat and prevent the acquisition of a lethal cutaneous fungal infection. The original animal studies were performed by DermBiont's Chief Scientific Officer, Rob Brucker, Ph.D. J.lividum has been found in soil, water, the human food chain, and as part of the normal human cutaneous microbiome.
About the Human Microbiome
The human microbiome is the community of microbes that inhabit humans most commonly on the epithelial surfaces of the gut, skin, respiratory tract, oral cavity, and genitalia. A healthy microbiome helps protect against bacterial and fungal infections as well as regulate the adaptive and innate immune systems.
DermBiont is a dermatology company leveraging skin microbiome therapeutics to treat the root causes of various skin diseases. In addition to advancing DBI-001 the company has a discovery platform based on a library of over 5,000 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. DermBiont's discovery platform and capabilities grew out of the company's tenure at the Illumina Accelerator in 2018.