Altasciences partners with Steel Therapeutics to advance Fizurex pivotal toxicology study

In a development that underscores the growing role of contract research organizations in accelerating specialty therapeutics, Altasciences has been selected by Steel Therapeutics, Inc. to conduct a pivotal toxicology study for Fizurex, its novel topical treatment for anal fissures. The study, which is being carried out at Altasciences’ GLP-compliant preclinical facility in Columbia, Missouri, marks a decisive milestone as Steel prepares to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in early 2026.

Steel Therapeutics’ decision to engage Altasciences reflects a broader trend in the pharmaceutical and biotech sector: smaller innovators are increasingly outsourcing mission-critical preclinical and clinical services to specialized CROs to accelerate time-to-market while ensuring regulatory compliance.

Why does the initiation of a pivotal toxicology study signal a major turning point for Fizurex regulatory advancement?

Toxicology studies conducted under Good Laboratory Practice standards are a crucial requirement before any therapeutic candidate can proceed to first-in-human trials. For Fizurex, a patent-pending compounded wipe that has already seen broad use in clinical practice, this regulatory pivot moves the product from real-world off-label adoption into a structured FDA review framework.

By formalizing Fizurex through the IND process, Steel Therapeutics aims to ensure consistent manufacturing quality, scale-up potential, and the ability to access insurance reimbursement channels once regulatory approvals are secured. Historically, many topical and compounded formulations have struggled to transition from small-scale physician-directed use to mainstream therapeutic adoption because of manufacturing inconsistencies and lack of FDA oversight. With the pivotal toxicology study underway, Steel is positioning Fizurex to avoid these pitfalls.

Altasciences, which has earned recognition for its integrated preclinical and clinical trial management approach, will be instrumental in helping Steel bridge the preclinical-to-clinical divide. The company’s COO emphasized that the partnership demonstrates how early collaboration between CROs and biotechs can fast-track the availability of therapies that otherwise risk being confined to niche usage.

How does Altasciences’ CRO model differ from traditional development pathways in pharma and biotech?

Unlike traditional pharmaceutical development that often segments discovery, preclinical, and clinical activities across multiple service providers, Altasciences offers an integrated model. This “under one roof” approach has become increasingly attractive for emerging biotech firms with limited internal infrastructure. Instead of navigating fragmented vendor networks and potential handoff inefficiencies, companies like Steel can rely on a single CRO to carry them from discovery through regulatory approval.

In the CRO landscape, Altasciences competes with global leaders such as Charles River Laboratories, Labcorp Drug Development, and ICON plc. However, its value proposition rests on its agility and ability to scale services for early-stage innovators. For rare diseases, specialty therapies, and niche indications like anal fissures—conditions that are often overlooked by large pharma—this model provides an accessible route to clinical validation without the prohibitive costs of building in-house capabilities.

Industry analysts have noted that integrated CROs can reduce development timelines by as much as 20–30 percent, particularly when regulatory documentation, toxicology assessments, and clinical trial initiation are managed cohesively. For Steel, a company still at the pre-IND stage, these efficiencies could significantly influence how quickly Fizurex moves into Phase I studies and beyond.

What makes Fizurex stand out in a crowded field of topical gastrointestinal therapies?

Anal fissures affect millions globally and are notoriously difficult to treat. Current standard therapies, including topical nitrates and calcium channel blockers, often have side effects such as headaches or systemic absorption concerns. Surgical interventions, such as lateral internal sphincterotomy, remain a last resort but carry risks of incontinence.

Fizurex enters this therapeutic landscape with a differentiated positioning: a topical, compounded wipe designed for ease of use, localized efficacy, and patient compliance. Having already been adopted in clinical practice outside the formal FDA pathway, it benefits from a degree of real-world validation that many preclinical candidates lack. The decision to seek FDA oversight is therefore not only about safety compliance but also about scaling access to a wider patient population through standardized production and distribution channels.

Steel Therapeutics’ founder described the toxicology study as a “major step forward” for patients who have long lacked reliable, tolerable, and consistent options. This patient-first framing resonates with recent FDA guidance, which increasingly emphasizes patient experience and usability in regulatory review processes.

How does this collaboration reflect broader trends in the outsourcing and specialty pharma sector?

The Altasciences–Steel collaboration exemplifies two converging industry dynamics: the rise of specialty-focused startups and the strategic importance of CROs in reducing development friction. Over the past decade, specialty pharmaceuticals have grown to represent more than 50 percent of global drug spending, with gastrointestinal disorders being a significant subcategory. Yet many conditions—particularly functional disorders such as anal fissures—remain underserved because they are not blockbuster markets.

For smaller players like Steel Therapeutics, securing CRO support from firms with established GLP compliance and regulatory navigation expertise is the only feasible path toward FDA approval. This outsourcing-driven model has become particularly prominent since the COVID-19 pandemic, when supply chain disruptions and regulatory backlogs forced many companies to rethink in-house versus outsourced development strategies.

For Altasciences, the partnership underscores its positioning as a CRO capable of handling not just preclinical studies but also downstream clinical and regulatory management. Such deals also strengthen its reputation in the specialty drug development community, where speed and quality are paramount.

What could investors and patients expect as Steel Therapeutics approaches the IND milestone in 2026?

While Steel Therapeutics is privately held and not listed on any public exchange, the company’s progress has implications for both patients and potential future investors. An IND filing in early 2026 could pave the way for first-in-human studies later that year. If early safety and tolerability data prove positive, Fizurex could quickly advance to efficacy trials, creating a streamlined path to a New Drug Application (NDA).

From a market perspective, analysts expect increasing M&A activity in the specialty gastrointestinal segment, where larger pharmaceutical companies often acquire promising niche assets once proof-of-concept is established. If Fizurex demonstrates strong clinical outcomes and favorable patient adoption trends, Steel could become an attractive acquisition target, providing an exit pathway for early investors.

For patients, the benefit lies in the potential for a standardized, FDA-approved therapy that could be reimbursed by insurers and widely distributed across pharmacies and hospitals. This would represent a significant step up from compounded, clinic-based access, which often varies in quality and availability.

The next twelve months will be critical for Steel as it navigates toxicology reporting, IND submission preparation, and the design of its first-in-human clinical trials. Partnerships like the one with Altasciences will remain essential in ensuring that regulatory timelines stay on track and that Fizurex maintains its momentum toward becoming a widely available therapy.