Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™

Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials.

The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026.

Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review.

"We are proud to have supported Steel Therapeutics with the generation of the high-quality safety data needed to advance Fizurex™ toward IND submission and first-in-human evaluation," said Steve Mason, Co-Chief Operating Officer at Altasciences. "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."

The study was conducted at Altasciences' GLP-compliant nonclinical research facility in Columbia, MO, and leveraged the company's expertise in toxicology, regulatory-supportive safety assessments, and integrated drug development services. The teams at Altasciences and Steel Therapeutics 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™ to patients," said Matt Stahl, CEO and Founder of Steel Therapeutics. "We thank the Altasciences 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 IND submission, Steel Therapeutics plans 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 team on reaching this important achievement and look forward to seeing the continued progress of the Fizurex™ program."

About Altasciences

Altasciences is a drug development solutions company helping pharmaceutical and biotechnology sponsors quickly move their programs from lead candidate selection to proof-of-concept. Through a flexible, customized approach, Altasciences partners with sponsors to accelerate development timelines, support informed decision-making, and achieve critical value inflection milestones faster. For more than 30 years, Altasciences has provided the expertise, resources, and strategic support needed to advance early-phase drug development efficiently and confidently. Altasciences’ solutions include nonclinical safety testing, clinical pharmacology and proof-of-concept, formulation, manufacturing, and analytical services, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all tailored to specific sponsor requirements. To learn more, visit altasciences.com.

About Steel Therapeutics, Inc.

Steel Therapeutics’ mission is to improve the lives of patients by scaling access to compounded drugs that have a proven track record of safety and effectiveness, particularly in the GI space. With a team of pharmacist-founders who have built and operated retail compounding programs, Steel is well positioned to identify both high impact drug candidates and innovative delivery systems.

Steel has selected a proven treatment for anal fissures as its product entry point. The company’s Fizurex™ wipe utilizes a combination therapy that is commonly compounded by pharmacists and incorporates it into a single-use wipe. By bringing rigorous safety and efficacy testing, Current Good Manufacturing Practices (CGMP), and a patient friendly format to this drug combination, Steel believes it can dramatically improve outcomes for patients.

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