Altasciences Completes Pivotal Toxicology Study for Steel Therapeutics' Fizurex™, Clearing Path to IND Filing for Anal Fissure Treatment
Key Insights
Altasciences (search) successfully completed a GLP-compliant pivotal toxicology study for Steel Therapeutics (search)' lead candidate Fizurex (search)™, demonstrating a favorable safety profile.
Steel Therapeutics (search) plans to submit an Investigational New Drug (IND) application to the FDA in Q3 2026, with first-in-human clinical studies anticipated in 2027.
Fizurex (search)™ is a patent-pending, single-use topical wipe delivering a combination therapy for anal fissures (search), a painful and often undertreated medical condition.
Altasciences (search), a leading drug development organization, announced the successful completion of a pivotal GLP-compliant toxicology study for Steel Therapeutics (search)' lead product candidate, Fizurex (search)™, marking a significant step toward first-in-human trials for the novel anal fissure treatment. The favorable safety data generated from the study positions Steel Therapeutics to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in Q3 2026.
"We are proud to have supported Steel Therapeutics (search) with the generation of the high-quality safety data needed to advance Fizurex (search)™ toward IND submission and first-in-human evaluation," said Steve Mason, Co-Chief Operating Officer at Altasciences (search). "The successful completion of this pivotal toxicology study demonstrates the value of close collaboration between our scientific teams and highlights Steel Therapeutics' commitment to advancing innovative therapies that address unmet patient needs."
A Novel Approach to an Undertreated Condition
Fizurex (search)™ is a patent-pending, single-use topical wipe designed to provide a standardized, accessible treatment option for anal fissures (search), a painful and often undertreated medical condition. The product utilizes a combination therapy that is commonly compounded by pharmacists and incorporates it into a patient-friendly, single-use format. By bringing rigorous safety and efficacy testing, Current Good Manufacturing Practices (CGMP), and a standardized delivery system to this drug combination, Steel Therapeutics (search) aims to dramatically improve outcomes for patients who currently rely on compounding pharmacy prescriptions.
Steel Therapeutics (search)' mission focuses on scaling access to compounded drugs with proven safety and effectiveness track records, particularly in the gastrointestinal space. The company's team of pharmacist-founders brings direct experience from building and operating retail compounding programs, positioning them to identify high-impact drug candidates and innovative delivery systems.
Regulatory Pathway and Next Steps
The GLP-compliant toxicology study was conducted at Altasciences (search)' nonclinical research facility in Columbia, Missouri, leveraging the organization's expertise in toxicology, regulatory-supportive safety assessments, and integrated drug development services. The teams at Altasciences and Steel Therapeutics (search) worked closely together to efficiently execute the program and maintain momentum toward key development milestones.
"This milestone brings us one step closer to bringing Fizurex (search)™ to patients," said Matt Stahl, CEO and Founder of Steel Therapeutics (search). "We thank the Altasciences (search) team for their dedication, expert execution, and scientific acumen in helping us reach this important achievement. This progress positions us well as we prepare for the next phase of development."
Following the planned IND submission in Q3 2026, Steel Therapeutics (search) intends to initiate first-in-human clinical studies in 2027.
"Our goal is to help sponsors move promising therapies through development with confidence, efficiency, and speed," added Mason. "We congratulate the Steel Therapeutics (search) team on reaching this important achievement and look forward to seeing the continued progress of the Fizurex (search)™ program."