Sanofi’s Oral TNF Experiment Runs Into Trouble in Psoriasis Trial

Sanofi tested an oral small molecule drug called balinatunfib in a Phase 2 psoriasis trial.

And it did not work well enough.

The drug failed to beat placebo on the main endpoint, which basically means it did not show meaningful improvement compared to people who got no active treatment.

Because of that result, the company is stepping back from using it as a standalone treatment.

Why this drug was even being developed

To understand why this matters, you need a bit of context.

For the last 20 years, biologic drugs called TNF inhibitors have been a major breakthrough in treating autoimmune diseases.

The most well-known example is Humira, which changed how diseases like psoriasis and rheumatoid arthritis are treated.

These drugs work, but they are not perfect. Some issues include:

• Side effects in some patients 

• Loss of effectiveness over time 

• Need for injections instead of pills 

So companies started looking for oral alternatives that could hit the same pathway but in a more convenient and potentially safer way.

That is where balinatunfib came in.

What balinatunfib was supposed to do

Balinatunfib is a small molecule drug designed to target a specific part of the TNF system.

It was meant to block TNFR1, while leaving TNFR2 alone.

The idea behind this is simple in theory:

• TNFR1 is linked more with inflammation and disease 

• TNFR2 may have protective or regulatory roles 

So the hope was that selectively blocking one and not the other might reduce side effects while still controlling disease.

What the psoriasis trial tested

The Phase 2 study enrolled 221 patients with psoriasis.

Patients received balinatunfib as a single therapy, meaning no combination with other drugs.

The main goal was to see how many patients improved their symptoms by at least 75 percent after 12 weeks.

This is a standard way to measure psoriasis response in clinical trials.

What the results showed

After 12 weeks, the results were clear but disappointing.

Balinatunfib did not perform better than placebo on the main endpoint.

In simple terms:

• Patients on the drug did not improve significantly more than patients on placebo 

• The primary goal of the study was not met 

So from an efficacy standpoint, the monotherapy idea did not work in this trial.

What Sanofi said about the results

Sanofi explained that the failure might be related to the design of the study, calling it a limited Phase 2 trial.

The company also said something important: even though the drug did not work well enough as a standalone treatment, the safety profile still looks acceptable and similar to other oral psoriasis drugs.

So the message is not “this drug is useless,” but more like “this version alone is not enough.”

What happens to balinatunfib now

After this result, the company is no longer planning to develop balinatunfib as a monotherapy treatment.

Instead, the focus is shifting toward combination therapies.

The idea is that the drug might work better when paired with other treatments rather than used alone.

Why combinations are now the focus

The logic here is fairly straightforward.

Autoimmune diseases like psoriasis are complex. One pathway alone is often not enough to fully control inflammation.

So companies are increasingly looking at combination approaches where multiple immune pathways are targeted at the same time.

The thinking is:

• One drug alone may not reach high enough efficacy 

• Two drugs together may improve outcomes 

• Combined effects may also improve durability 

So even though monotherapy failed, the mechanism is not being fully abandoned.

Other diseases still in the pipeline

Sanofi is still testing balinatunfib in other conditions.

This includes:

• Rheumatoid arthritis, with Phase 2 data expected in the second half of 2025 

• Crohn’s disease 

• Ulcerative colitis 

The rheumatoid arthritis results are especially important because that disease already uses combination treatment strategies in many cases.

A second drug shows better results

Alongside this update, Sanofi also shared results from another program called brivekimig.

This is a different type of immune-targeting therapy tested in hidradenitis suppurativa, a painful inflammatory skin disease.

In this trial, brivekimig met its main endpoint, reducing abscess and inflammatory nodule counts.

Because of that, the company is prioritizing this drug for further development in that indication.

What this tells us about drug development

This update shows something very common in biotech development.

Not every mechanism that looks good in theory works in real patients.

Even when:

• The biology makes sense 

• The drug is well designed 

• Early expectations are high 

Clinical trials can still fail when tested at scale.

Final takeaway

Here is the simple version.

Sanofi tested an oral TNF pathway drug called balinatunfib in psoriasis.

It did not beat placebo, so it failed its main goal in Phase 2.

Because of that, the company is shifting away from using it alone and is now exploring combination therapy approaches instead.

At the same time, other pipeline drugs from the company are still showing promise, so the overall research effort continues, just with a different focus.