Sanofi Shifts Balinatunfib to Combination Therapy Following Phase 2 Setback in Psoriasis

2025Year4Month24Day, Sanofi (Sanofi) has encountered setbacks in the research and development process within the field of autoimmune disease treatment. The French pharmaceutical giant announced that its (Humira) Mechanism of action developed oral medicationbalinatunfib, in psoriasisIIFailed to reach the primary endpoint in the Phase III clinical trial. This outcome has forced the company to abandon the development plan of using this molecule as a monotherapy, and instead focus on combination therapy strategies.

 Phase 2 Trial Results: Monotherapy Efficacy Did Not Surpass Placebo

In a study involving221Patients with psoriasisIIIn the study period, patients receivedbalinatunfibMonotherapy12Weeks later, achieving at least symptom improvement75%（PASI 75) showed no statistically significant difference compared to placebo. This result was disclosed by Sanofi.2025In the first quarter earnings report. Despite the monotherapy efficacy not meeting expectations, the company still emphasized the drug's potential safety profile and its efficacy level.“Comparable to other oral psoriasis medications”Sanofi attributed the trial failure to“IILimitations of the Phase Study”, and the data supports its application value in combination therapy.

 From Monotherapy to Combination: Mechanistic Advantages and Market Strategies

(1) Potential for Differentiated Mechanism of Action

In the past20Year, with AbbVie (AbbVie) represented by Humira (TNF) Biologics have revolutionized the treatment landscape of autoimmune diseases. However, these drugs may cause adverse reactions, and some patients may experience loss of efficacy. Developed by Sanofi,balinatunfibIs an orally administered small moleculeTNFR1Inhibitors, which were originally designed to circumvent the limitations of biologics-Through selective inhibitionTNFR1(rather thanTNFR2), which is expected to reduce the side effects of traditional therapies and provide differentiated safety features.

(II) The Logic and Prospects of Combination Therapy

In2025Year1In the monthly earnings call, Sanofi's R&D headHouman AshrafianDr. once said, ifIIThe interim data supports the efficacy of the single drug, and the company plans tobalinatunfibPositioned as“Monotherapy Before Biologics”Now that the single-drug pathway is blocked, Sanofi has turned its focus to the development of combination therapies.

The logical basis for combination therapy includes: raising the efficacy ceiling --Combination blockade of cytokines can enhance therapeutic efficacy, breaking through the bottleneck of single therapies; prolonging durable responses--Combination therapy may maintain long-term efficacy through multiple mechanisms and reduce the occurrence of drug resistance; adaptable to the existing market--A treatment landscape of combination therapy has been formed in areas such as rheumatoid arthritis, providingbalinatunfibProvided potential application scenarios.

SanofiCEO Paul HudsonEmphasis:“If safety standards are met, the opportunities for combination therapy will be very significant.”Currently, the company is exploring fixed-dose combinations of this drug with other therapies, targeting indications that cover a variety of autoimmune diseases.

 Follow-up Layout

balinatunfibRheumatoid arthritis (RA）2Expected data is anticipated on2025The results will be announced in the second half of the year, which will verify whether it is suitable for further development as a component of combination therapy. Sanofi noted,RAMarket“Already belongs to the combination therapy market”, providing clear application directions for the drug.

The company has recently also startedbalinatunfibIn Crohn's disease (Crohn’s disease) and in ulcerative colitisIIPhase Trial.

InbalinatunfibAt the same time of the update, Sanofi announced another drug.brivekimigTheIIPositive results in the period. This targetedTNFxOX4OLNanobodies in Hidradenitis Suppurativa (hidradenitis suppurativa) trial, achieved“Total Abscess and Inflammatory Nodule Count Improvement”The primary endpoint, efficacy superior to similar drugsamlitelimab(Anti-OX40LAntibody). Currently,brivekimigHas been listed as a priority development project for this indication.

 Industry Insights

balinatunfibThe setback highlights the R&D challenges of oral small molecule drugs in the field of autoimmune diseases--Although some limitations of biologics have been circumvented, the efficacy of monotherapy may struggle to surpass the ceiling of existing treatments. However, Sanofi's strategic shift reflects an industry trend: optimizing outcomes through combination therapies, particularly by seeking breakthroughs in complementary mechanism-based target combinations. In the future,balinatunfibWhether it can regain vitality in combination therapy, and how Sanofi's pipeline in the field of autoimmune diseases will further evolve, is worth continued attention.

Compilation Source:fierce biotech

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