Sanofi's Oral TNF Inhibitor Falls Short in Psoriasis Trial, Shifts Focus to Combination Therapies

Sanofi's ambitious foray into developing an oral alternative to biologic TNF inhibitors has encountered a significant setback. The French pharmaceutical giant recently announced that its small molecule candidate, balinatunfib, failed to meet its primary endpoint in a phase 2 psoriasis trial, prompting a strategic pivot towards exploring combination therapies.

Trial Results and Implications

In a study involving 221 psoriasis patients, balinatunfib, when administered as a monotherapy, failed to demonstrate statistical superiority over placebo after 12 weeks of treatment. The primary endpoint measured the proportion of patients achieving at least a 75% improvement in symptoms.

Despite the disappointing outcome, Sanofi remains optimistic about the potential of balinatunfib. The company noted that efficacy levels were "comparable to other oral medicines in psoriasis" and that the data support a potentially differentiated safety profile. This has led Sanofi to recalibrate its approach, focusing on the drug's potential in combination therapies.

Strategic Shift and Future Prospects

Sanofi's head of R&D, Houman Ashrafian, had previously indicated that the company would pursue balinatunfib as a pre-biologic monotherapy if phase 2 data supported single-agent use. With this avenue now closed, Sanofi is redirecting its efforts towards combination strategies.

CEO Paul Hudson emphasized the significance of this shift, stating, "If safety is right, the combination opportunity is significant." The company believes that combining balinatunfib with other drugs could potentially increase efficacy and provide greater durability of response.

Sanofi continues to evaluate balinatunfib in other indications. Phase 2 data in rheumatoid arthritis is expected in the second half of 2025, and the company has recently initiated phase 2 trials in Crohn's disease and ulcerative colitis.

Broader Pipeline Developments

In parallel with the balinatunfib update, Sanofi reported positive results from a phase 2 trial of brivekimig, a TNFxOX4OL nanobody, in hidradenitis suppurativa. The study met its primary endpoint, which assessed the effect on total abscess and inflammatory nodule count. Sanofi is prioritizing brivekimig in this indication due to its apparently superior efficacy compared to the anti-OX40L antibody amlitelimab.

As Sanofi navigates these mixed results, the company's strategic decisions in the coming months will be crucial in determining the future trajectory of its immunology pipeline and its position in the competitive landscape of autoimmune disease treatments.