Sanofi stated it is re-evaluating the monotherapy approach for balinatunfib in psoriasis following disappointing Phase II results, while continuing clinical development in other indications and investigating combination approaches.
Preliminary data from the SPECIFIC-PSO Phase II study (NCT06073119) showed that while balinatunfib achieved clinically relevant changes in the primary endpoint—PASI-75 response—with efficacy comparable to other oral psoriasis medications, it failed to reach statistical significance. Sanofi attributed this shortfall to "the nature of this limited Phase II study."
PASI-75, a standard metric in psoriasis clinical trials, measures whether patients experience a 75% reduction in symptoms compared to baseline. This benchmark is widely used to evaluate the efficacy of psoriasis treatments.
Trial Design and Safety Profile
The Phase II randomized, double-blind, placebo-controlled trial enrolled 221 patients with moderate to severe plaque psoriasis who received treatment for 12 weeks. Despite missing the primary endpoint, Sanofi reported that balinatunfib was generally well-tolerated across all dosage levels, with no new safety concerns emerging during the study.
The company plans to present the complete dataset at an upcoming medical conference, providing the scientific community with a more comprehensive understanding of the drug's performance.
Pivot to Combination Therapy Approach
Rather than abandoning the compound entirely, Sanofi believes balinatunfib may have greater potential as part of combination therapy regimens. The company is currently conducting internal assessments and external discussions to identify promising combination strategies, including fixed-dose combinations for various inflammatory conditions.
"The data suggests balinatunfib could be better suited for investigation as part of a combination therapy," according to Sanofi's statement. This strategic pivot reflects the company's commitment to exploring alternative development pathways for promising compounds that don't succeed as standalone treatments.
Ongoing Clinical Development
Despite this setback in psoriasis, balinatunfib's clinical development continues in other inflammatory conditions. The drug is currently being evaluated in Phase II trials for rheumatoid arthritis (NCT06073093), Crohn's disease (NCT06637631), and ulcerative colitis (NCT06867094).
These ongoing studies will help determine whether balinatunfib demonstrates greater efficacy in other inflammatory disorders and provide additional safety data across diverse patient populations.
TNF Inhibitor Market Context
The TNF inhibitor class has a well-established history in treating inflammatory conditions, with the first approvals occurring approximately 20 years ago. AbbVie's Humira (adalimumab) stands as the most commercially successful TNF inhibitor, becoming one of the world's best-selling drugs of all time.
Since receiving initial FDA approval in 2002, Humira gained indications across 10 different conditions. According to GlobalData, Humira reached its commercial peak in 2022 with global sales of $21.59 billion before facing patent expiration.
Other significant TNF inhibitors in the market include Johnson & Johnson's Remicade (infliximab), Amgen's Enbrel (etanercept), and UCB's Cimzia (certolizumab pegol). These biologics have transformed treatment paradigms for numerous inflammatory conditions but require parenteral administration.
Significance of Oral TNF Inhibitors
Balinatunfib represents part of the industry's ongoing efforts to develop oral alternatives to injectable TNF inhibitors. An effective oral TNF inhibitor could potentially address patient preference for oral administration while potentially reducing costs associated with biologic therapies.
While this particular development program has encountered challenges as a monotherapy, the continued exploration of balinatunfib in combination regimens and other indications highlights the pharmaceutical industry's persistence in developing more convenient treatment options for patients with inflammatory conditions.
The outcome of Sanofi's investigation into combination approaches will be closely watched by clinicians and industry observers interested in the evolution of TNF inhibitor therapies and novel approaches to treating autoimmune disorders.
