First Tracks climbs on ‘impressive’ celiac study data

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Dive Brief:

• An experimental drug from First Tracks Biotherapeutics helped reduce signs and symptoms of celiac disease in an early-stage trial. 
• When compared to a placebo after six weeks of treatment, First Tracks’ drug ANB033 produced a statistically significant improvement on a measure evaluating how well a therapy protects the intestinal lining from gluten-induced damage. The drug hit its marks on other evaluations of disease severity, and also prevented an increase in symptoms during a “gluten challenge,” First Tracks said.
• There were no serious adverse events related to treatment, nor were there any side effects that led drug recipients to leave the trial. First Tracks will report data from a second study cohort in the first quarter of next year, and expects to start a late-stage trial in 2027 as well. 

Dive Insight:

Celiac disease is an immune disorder in which consuming gluten causes the body to mistakenly attack the small intestine. Over time, the damage disrupts the absorption of vitamins and minerals, triggering deficiencies and digestive symptoms. While a strict diet can help sidestep these issues, some drugmakers are hoping an emerging, targeted kind of medication could provide a different option. 

First Tracks, Argenx and Teva Pharmaceuticals all have drug prospects in clinical testing against celiac. First Tracks’ drug ANB033 blocks the activity of CD122, a receptor component used by two immune-regulating proteins IL-2 and IL-15. Argenx’s therapy, acquired in a recent buyout, also targets CD122. Teva’s treatment homes in on IL-15 specifically.  

Teva and Argenx’s drugs have already shown promise in early celiac trials. Their success heightened anticipation for the findings First Tracks reported on Monday. 

First Tracks enrolled 32 participants and randomized them to receive a placebo or three subcutaneously administered doses of ANB033 over the course of four weeks. Participants then underwent a two-week gluten challenge, which was the equivalent of eating about two slices of bread each day.

ANB033 hit statistical significance on three different study measures assessing biological signs of celiac. Those findings, as well as “clean safety,” make for “impressive” initial results, wrote Leerink Partners analyst David Risinger in a Monday client note. 

Though the two drugs haven’t been formally tested against one another, First Tracks’ data compares “favorably” to the results Teva disclosed last month, Risinger wrote. 

“We view ANB033 as having pipeline-in-a-product potential across several autoimmune diseases,” he added.

The drug is also being tested in a Phase 1b trial in eosinophilic esophagitis, with data expected in the third quarter of 2027. First Tracks said it is also on track to start Phase 2 development in the skin disease vitiligo, as well as another unnamed indication, in the first half of 2027.

“Celiac disease is the largest autoimmune disease without an approved treatment,” Monique da Silva, First Tracks’ senior vice president of corporate affairs, told BioPharma Dive.

Should the early results be confirmed in further testing, the drug could offer people with the condition a “new layer of protection beyond the gluten-free diet,” she added. 

Company shares climbed about 7% in Monday trading.