Altasciences is pleased to have been chosen by Steel Therapeutics, Inc. (“Steel”), to initiate a pivotal toxicology study for Fizurex™, a novel topical therapy for the treatment of anal fissures.

The GLP-compliant study is currently being conducted at Altasciences’ preclinical facility in Columbia, MO. It marks a key milestone in Steel’s regulatory development, as the company prepares for an Investigational New Drug (IND) application in early 2026.

“We’re proud to be supporting Steel Therapeutics at this key stage of their development journey,” said Steve Mason, Co-COO at Altasciences. “Our teams are aligned in their commitment to accelerate the delivery of patient-centered therapies. The initiation of this study is another example of how early collaboration and scientific rigor can bring important treatments closer to market.”

Fizurex™, a patent-pending compounded wipe, has seen widespread use in clinical practice and is now progressing through the formal regulatory pathway to reach broader patient populations under FDA oversight. Steel engaged Altasciences due to their deep expertise in preclinical safety evaluation and proven ability to execute with speed and precision.

“Working with Altasciences allows us to maintain the highest standards of quality as we move Fizurex™ into its next phase of development,” said Matt Stahl, CEO and Founder of Steel Therapeutics. “This study represents a major step forward for our company and for the patients who stand to benefit from more consistent, scalable access to this treatment.”

Altasciences’ integrated, collaborative approach to drug development enables companies like Steel to move efficiently from discovery through to clinical trials, all under one organizational umbrella.

“We look forward to continuing our partnership with Steel Therapeutics as they advance their portfolio of innovative, patient-focused therapies,” added Mason.

About Altasciences

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, research support, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.

About Steel Therapeutics

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. 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 novel 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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The GLP-compliant study is currently being conducted at Altasciences’ preclinical facility in Columbia, MO. It marks a key milestone in Steel’s regulatory development, as the company prepares for an Investigational New Drug (IND) application in early 2026.