ANB033 Celiac Trial Results: Promise and Questions

Another celiac drug just reported encouraging results. And the question is getting bigger than “Will I get to eat a doughnut?”

On October 12, First Tracks Biotherapeutics announced positive Phase 1b results for ANB033—an investigational drug targeting CD122, the same immune receptor targeted by FB102.

That gives us another reason to pay attention. It also gives us more to think about.

I want more options for treating celiac disease. But I want enough information to understand what those options would actually mean for my life.

What the ANB033 study found

Thirty-two participants completed dosing and a 14-day challenge involving 6 grams of gluten every day, following three injections of ANB033 or placebo.

Remember: these people are putting their bodies on the line for science. They deserve a HUGE round of applause and our thanks.

The company reported less intestinal damage and lower symptom scores with ANB033 than with placebo. About 47% of placebo participants used permitted medications for gastrointestinal symptoms, compared with 6% receiving the drug.

That medication comparison caught my attention. It adds something practical to the laboratory and biopsy measurements: how much additional help people needed during the challenge.

It does not mean everyone receiving the drug felt fine. But it is a detail worth examining alongside the other results.

These early, company-reported findings provide evidence of benefit under the conditions tested. They do not settle lasting protection or long-term safety.

A small introduction to CD122

CD122 is part of the receptor machinery immune cells use to respond to two signaling proteins: IL-2 and IL-15. ANB033 is designed to interfere with signaling through that machinery.

For today, the important distinction is where the treatment acts.

A gluten-degrading treatment aims to break down gluten. A CD122-targeting antibody acts on immune signaling involved in the response.

That difference changes the questions we need to ask.

How much of the harmful response can treatment interrupt? What happens to normal immune functions? How does the balance look after months or years of treatment?

Those questions need clinical answers.

And targeting the same receptor does not make ANB033 and FB102 interchangeable. Different antibodies can behave differently. Their trials also differ, so we cannot compare the announcements and declare a winner.

This is different from the treatment I had pictured

Heck, I had always pictured a celiac treatment as a pill before a meal.

These drugs are making me rethink that picture.

ANB033 was administered by injection in this study. FB102’s recent Phase 2 study used intravenous infusions. Those research regimens do not establish the eventual treatment schedule, but they show why this conversation extends beyond taking a pill before dinner.

Would treatment mean regular injections? Infusion appointments? Monitoring? What would the trade-off look like?

I am not automatically opposed to ongoing treatment. Plenty of people take medication regularly because the benefits are worth it.

But “worth it” requires knowing both what we gain and what we take on.

Will the protection be enough to change our lives?

A controlled gluten challenge helps researchers investigate protection.

It does not, by itself, establish that we can return to an unrestricted gluten-containing diet.

Before considering treatment, I would want answers to these questions:

• How often would treatment be needed? How long would protection last between doses?
• How much exposure could it reliably protect against? How would study results translate into everyday life?
• Would it meaningfully reduce both damage and symptoms? Those outcomes matter, and they are not interchangeable.
• What side effects and long-term risks would come with it? What monitoring would be required?
• What would it cost? Would insurance cover it, and for whom?

Protection during treatment is also different from a cure.

I would not require a medication to keep working forever after I stopped taking it. I would want to understand how reliably it works while I am taking it.

And I want us to leave room for different answers.

Someone seeking protection from accidental exposure may weigh treatment differently from someone hoping for a substantially less restricted diet. Someone struggling despite careful management may weigh it differently from someone doing well.

That is why this cannot become a competition over who wants a treatment badly enough—or who is supposedly managing their disease better.

There is a bigger business story here, too

CD122 is not relevant only to celiac disease.

Argenx has described FB102’s potential across celiac disease, vitiligo, alopecia areata and other autoimmune conditions. The company explicitly identified early celiac and vitiligo findings as important drivers of its decision to acquire Forte.

That broader potential raises a business question I want to explore tomorrow.

Could several possible uses make a drug a more viable investment than a treatment focused specifically on breaking down gluten?

My interpretation is that additional potential uses can give a development program more opportunities. A disappointing result in celiac disease would not automatically eliminate every other possible application.

But the reason for the disappointment would matter. A result specific to celiac disease could have different implications from a broader safety problem or a failure of the underlying approach.

We cannot assume that success—or failure—in one disease translates directly to another.

Tomorrow, we will look more closely at how that changes the investment calculation, and what it could mean for the future of celiac treatment research.

We have time to ask better questions

Argenx plans to advance FB102 into Phase 3 development. First Tracks anticipates a late-stage celiac trial in 2027. Those are development plans, not guaranteed approval dates.

I am not saying these drugs are the answer for everyone—or even for me.

I am saying the possibilities are becoming more concrete, and so are the questions.

I want more options. I also want enough information to decide what those options would mean for my life.

That is why we go beyond the headlines here: to understand what was tested, what remains unanswered, and what a promising result could mean for a person living with celiac disease.

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Sources

• First Tracks: ANB033 Phase 1b results, October 12, 2026
• Argenx: FB102 Phase 2 results, October 8, 2026
• Argenx: Forte acquisition announcement, July 27, 2026