Steel Therapeutics is a pharmaceutical company focused on increasing access to compounded drug therapies.
Founded in 2020 by Matt Stahl and Robbie Schwenker, the company hopes to take compounding drugs through the FDA approval process, making them more widely and easily available.
“Compounded drugs are not FDA approved. The downside of that is they aren’t usually covered by insurance and some physicians might be more reluctant to subscribe to these and their dosages might not be fully optimized yet. All of this limits their use for patients even though they might be the best options,” said Stahl. “So we came up with this solution to bring these potentially safer and more effective drugs through the FDA approval process in order to open several billion-dollar markets that increase access to better medications with verified quality, improved patient outcomes through our patented delivery methods, and coverage by insurance.”
Steel Therapeutics first solution they are bringing to market is a patent-pending Fizurex wipe that uses combination therapy that is individually packaged, single-use and flushable wipe. Individuals are able to use the product “on-the-go” to treat anal fissures that occur in about 1 in 350 adults, according to their website.
Stahl says he expects the Fizurex wipe to be FDA approved and come to market by 2026. The company is currently doing preclinical development and is expecting to start animal studies next year.
“The typical FDA approval process takes about 10 years. The way that we’re doing it allows us to get it done in about 5 years, cutting that time in half,” said Stahl. “Because compounded drugs already have some of that safety and efficacy data available that we can leverage.”
Earlier this year, the company took part in the Spring 2021 cohort of the Iowa Startup Accelerator (ISA). Following the program, the company successfully closed a seed round led by ISA Ventures.
“ISA was an incredible program,” said Stahl. “They provided my team and me with mentorship and experience that really helped us polish our vision, create a pitch deck, provide company development resources, and initial funding. We came out of the program with a solid business plan, and the next steps in place that led us to partnerships with a drug manufacturer and an FDA regulatory consultant group, and the successful close of our first funding round.”