Steel Therapeutics, an early-stage pharmaceutical company based in North Liberty, has secured $2 million in strategic investment to advance development of Fizurex, its patent-pending topical wipe for treating anal fissures. The funding round was led by new strategic investors and will support a pivotal toxicology study and preparation for an Investigational New Drug (IND) application.
Fizurex Development Program Advances
The company has launched a pivotal toxicology study for Fizurex in partnership with Altasciences, a contract research organization with more than 30 years of experience in preclinical and clinical development services. The Good Laboratory Practice-compliant study, conducted in minipigs, represents a critical step toward the company's planned IND submission in early 2026, which would enable first-in-human clinical trials.
"The start of this pivotal toxicology study marks a critical inflection point for Steel Therapeutics," said Matt Stahl, CEO and founder of Steel Therapeutics. "Fizurex is already massively de-risked from a clinical use perspective, having been prescribed by compounding pharmacies as a standard of care for years."
Addressing Treatment Gaps in Anal Fissures
Fizurex is designed as a single-use wipe treated with a topical therapy that aims to offer a more accessible and consistent alternative to traditionally compounded treatments for anal fissures, a condition that currently has limited therapeutic options. The product uses a commonly compounded combination therapy in a single-use format, with the goal of improving consistency, safety and access for patients.
"Our work is focused on bridging the gap between proven compounded treatments and the rigor of FDA oversight," Stahl explained. "Fizurex is our first step toward building a platform that empowers prescribers and patients with reliable, accessible, and effective therapies."
Strategic Partnerships and Development Timeline
Steel Therapeutics is transitioning from early formulation and proof-of-concept work to formal preclinical development and regulatory engagement. The company has established relationships in the current Good Manufacturing Practice (CGMP) space to support both the upcoming pivotal animal study and first-in-human studies planned to start next year.
"We've made tremendous progress over the last several months continuing to develop and validate the Fizurex wipe, while also establishing relationships in the CGMP space that will serve us well in both our upcoming pivotal animal study and the first-in-human studies that have already been scoped for a planned start next year," Stahl said.
Steve Mason, co-chief operating officer at Altasciences, noted the collaboration's significance: "It's a privilege to work with Steel Therapeutics as they advance their Fizurex preclinical program. By combining our teams' expertise and shared commitment to patient-driven research, we're helping move this promising therapy one step closer to those who need it."
Company Background and Vision
Steel Therapeutics was founded by a team of pharmacists with experience in retail compounding. The company's goal is to scale access to compounded drugs with a strong safety and effectiveness record, applying pharmaceutical manufacturing standards to improve delivery and patient outcomes. Fizurex is positioned as a bridge between compounded therapies and FDA-regulated pharmaceutical products, representing the company's first product in building a platform for reliable, accessible, and effective therapies.
