Dr. Evangelos Badiavas, a dermatologist at the University of Miami Health System and cofounder of Aegle Therapeutics, a biotech company, has spent most of his career working with stem cells and how they can be used to regenerate skin to treat burn victims and chronic wound patients. But little did he know that along the way, his research would lead him to discover a treatment for a rare genetic pediatric connective tissue disorder.
The disease in question is called dystrophic epidermolysis bullosa (DEB) and it’s the result of a single gene mutation. DEB prevents the production of collagen in the skin, which results in the skin being extremely fragile and blistering off easily. It usually begins in infancy, and the children who have this condition resemble patients with severe burn wounds and need to be all bandaged up so the raw tissue isn’t exposed and thus prone to infection. According to Stanford University, DEB affects between 25,000 and 50,000 people in the U.S.
“It’s the worst disease you’ve never heard of,” said Shelley Hartman, CEO, and co-founder of Aegle Therapeutics, the company that’s leading Dr. Badiavas’ go-to-market strategy.
DEB has a number of distinct forms: In the least severe form, blistering is confined to the hands and feet. In more severe cases, the whole body is affected and wounds heal very slowly, which can create scarring, physical deformity and significant disability. It can also affect people’s throats, which can make it hard for them to eat, resulting in the need of a feeding tube. People who have DEB have a life expectancy of 30-40 years less than healthy adults, that is, if they survive childhood to begin with.
“If you pick up a baby from under their arms, their skin just peels off,” said Hartman, emphasizing how horrific the disorder is.
Down to Business
Aegle closed its Series A in September 2020 for a total of $6.5 million. The round was led by New World Angels and included Tellus BioVentures, LLC, Defta Healthcare Technologies, LP and DeepWork Capital. Its total amount of funding thus far is $7.1 million. In a previous friends and family round, Aegle raised $600K, led by Bill Pruitt who co-founded Ocean Azul Partners. According to Hartman, when Pruitt put his money in Aegle, he said, “I’m either going to make a ton of money, or I’m going to lose it all.”
Before co-founding Aegle, Hartman worked in investment banking at Goldman Sachs in New York. She served as Head of Global Medical Device and Head of Healthcare Services in the Investment Banking Division, where she advised on strategy, M&A, principal investing, and capital raising. She was then recruited by LifeSynch, a medical device startup in Ft. Lauderdale, where she worked for 12 years, culminating her tenure as Chairman and CEO. Hartman holds a B.A. in economics from Wellesley College. She co-founded Aegle in 2014.
“Having been in i-banking, I had a strong background in M&A and raising funds,” Hartman said. But despite her stellar experience, Hartman found it difficult to raise money in South Florida. “People expected us to be really far along,” she said. She then added, “For everybody, but especially for women, results count.”
Where they are now
Getting a new treatment to market can be quite involved, as there are many phases and tests to pass before the FDA approves it. In 2021, Dr. Badiavas’ treatment will be offered in a phase 1/2a clinical trial, a study that tests the safety, side effects, and best dose of a new treatment.
Working with actual stem cells can be onerous and costly, so Aegle developed a proprietary approach that is cell-free and has the potential to demonstrate a safer, lower-cost means of harnessing the regenerative healing power of stem cells without using the cells themselves.
The team of 5 – normally based out of CIC – is in the process of taking the manufacturing process out of the lab and is starting two clinical trials in 2021. If you are someone you know would be interested in participating in a trial, you can contact Aegle at: EVTrial@aegletherapeutics.com