Altasciences Chosen by Steel Therapeutics to Advance Pivotal Toxicology Study for Fizurex™
Altasciences, a leading provider of integrated drug development solutions, announced that it has been selected by Steel Therapeutics, Inc. (“Steel”) to initiate a pivotal toxicology study for Fizurex™, a novel topical therapy being developed for the treatment of anal fissures. The study, which is fully compliant with Good Laboratory Practice (GLP) standards, is currently underway at Altasciences’ state-of-the-art preclinical research facility in Columbia, Missouri. This critical milestone marks an important step forward for Steel as it works toward submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), a filing anticipated in early 2026.
Addressing an Overlooked but Widespread Condition
Anal fissures, though often under-discussed due to stigma, represent a painful and surprisingly common condition affecting a large segment of the population worldwide. The disorder is characterized by small tears in the lining of the anal canal, which can cause severe pain, bleeding, and disruption to daily life. Despite the prevalence of the condition, treatment options remain limited, with many patients relying on compounded, clinic-specific formulations that are not standardized across healthcare systems.
Fizurex™, Steel Therapeutics’ lead candidate, aims to change this. Developed as a patent-pending topical wipe, Fizurex™ provides a convenient, hygienic, and patient-friendly delivery system that has already demonstrated strong adoption in clinical practice. While patients and physicians alike have expressed confidence in its benefits, the product’s move into the formal regulatory pathway ensures that a much wider population can gain access to a consistent, FDA-approved treatment that meets the highest standards of safety, quality, and scalability.
A Critical Preclinical Milestone
The initiation of this GLP-compliant toxicology study is a pivotal inflection point in Fizurex™’s journey. Toxicology studies are essential components of drug development, providing the safety data required by regulators before a therapy can proceed into human trials. For Steel Therapeutics, partnering with Altasciences ensures that this stage of development is executed with both scientific rigor and operational efficiency.
“We’re proud to be supporting Steel Therapeutics at this key stage of their development journey,” said Steve Mason, Co-Chief Operating Officer 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.”
Why Steel Chose Altasciences
Steel Therapeutics’ decision to partner with Altasciences reflects the latter’s reputation as a trusted partner for biotechnology and pharmaceutical companies navigating complex regulatory milestones. Altasciences offers a broad spectrum of services—spanning preclinical safety evaluation, clinical trial execution, and manufacturing support—all within a single, integrated framework.
By choosing a partner that can manage multiple aspects of the drug development continuum, Steel gains both speed and consistency in advancing Fizurex™. In addition, Altasciences’ experience in topical drug formulations and their deep expertise in designing studies that meet stringent regulatory standards were key factors in the collaboration.
“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.”
From Compounding to Commercialization
One of the distinguishing features of Fizurex™’s development journey is its origin in the clinical practice setting. Many patients have already benefited from versions of this therapy through compounded preparations, which are often created in small batches by specialty pharmacies or medical practices. While such formulations can provide relief, they lack the standardization, quality control, and regulatory oversight of FDA-approved medications.
By advancing Fizurex™ into formal drug development, Steel Therapeutics is bridging the gap between patient need and pharmaceutical rigor. If successful, Fizurex™ could become the first widely available, FDA-approved topical wipe specifically indicated for anal fissures, ensuring broader accessibility and consistent therapeutic benefit for patients nationwide.
Altasciences’ Integrated Model
The collaboration also highlights the growing appeal of Altasciences’ integrated drug development model, which enables clients to transition seamlessly from discovery through to clinical testing under one organizational umbrella. This model minimizes the operational inefficiencies and knowledge gaps that can occur when multiple vendors are involved, thereby accelerating timelines and reducing risk.
Altasciences’ preclinical facility in Columbia, Missouri, where the Fizurex™ toxicology study is being conducted, is equipped with advanced technology and staffed by highly experienced scientists specializing in safety and regulatory studies. Their ability to generate reliable, regulator-ready data is instrumental for emerging biopharmaceutical companies like Steel that are preparing for IND submissions.
“We look forward to continuing our partnership with Steel Therapeutics as they advance their portfolio of innovative, patient-focused therapies,” added Mason.
As Steel Therapeutics progresses toward its IND submission in early 2026, the successful execution of this toxicology study will be a defining achievement. The outcome will provide essential safety data to support Fizurex™’s transition into first-in-human trials, bringing the therapy closer to potential FDA approval and, ultimately, to the patients who need it most.
The collaboration between Steel and Altasciences underscores the value of strategic partnerships in biopharma development. By combining Steel’s innovative product vision with Altasciences’ development expertise, both companies are working to accelerate the availability of meaningful therapies for conditions that have long been underserved.
With anal fissures often overlooked in the broader conversation about gastrointestinal health, the advancement of Fizurex™ has the potential to set a new standard of care in an area of significant unmet need. As the study progresses, patients, clinicians, and the broader medical community will be watching closely—hopeful that this effort will soon deliver a safe, effective, and accessible solution.
