Hey readers! Here's something that would have sounded unlikely a couple of years ago: in the span of a few weeks, two different companies reported that blocking the same immune target protected celiac patients from gluten during controlled challenges. If you're keeping a list of therapies worth tracking, this issue hands you several named places to look, starting with argenx's FB102, First Tracks' ANB033, and Teva's TEV'408.
🔬 argenx FB102 hits its Phase 2 mark
argenx Announces Positive Topline Results from Phase 2 Study of FB102 in Celiac Disease is the anchor here: on October 8, 2026, argenx said its FB102-301 study met its primary endpoint, change from baseline in the villus height-to-crypt depth (Vh:Cd) ratio at day 78 during an eight-week oral gluten challenge, with p=0.0176 versus placebo.
– argenx via GlobeNewswire
Why this matters: FB102 is a first-in-class CD122 inhibitor, and argenx describes this as the first Phase 2 clinical evidence that blocking CD122 can prevent gluten-induced intestinal damage in celiac disease. The company reported consistent results across IEL density, the VCIEL composite score, and symptoms, no new safety signals, and FDA Fast Track Designation. It plans to advance into Phase 3.
"Combined with the consistent safety profile observed across studies, these findings support advancing FB102 into Phase 3 development and further exploring its broader potential across immune-mediated diseases," said argenx chief medical officer Luc Truyen, as reported by Mugglehead.
A few practical notes on how to read this. Per a Pashutfree analysis, the trial enrolled 126 adults in a randomized, double-blind 2:2:1 design (two IV FB102 doses or placebo), all of whom had followed a strict gluten-free diet for at least 12 months without symptoms before the supervised challenge. That same write-up is refreshingly blunt about limits:
"This is progress towards testing a medicine, not evidence that celiac disease has been cured."
The absolute group differences and detailed symptom scores haven't been released yet; argenx says full results will come at a future medical meeting. NovaPharmaNews adds a useful caveat for anyone cross-checking the registry: ClinicalTrials.gov still lists NCT06982963 as recruiting, with sponsor Forte Biosciences and primary completion estimated for February 28, 2027, and there are discrepancies between the registry and the press release on sponsor name, enrollment, and the primary measure. Worth watching the detailed readout before drawing firm conclusions. This was also the first FB102 clinical readout since argenx completed its acquisition of Forte Biosciences in August 2026.
🧬 A second CD122 drug, days later
Then, on October 12, 2026, a different company hit a strikingly similar note. First Tracks Biotherapeutics Announces Positive Top-Line Results for ANB033 in Gluten Challenge Study in Celiac Disease reported Phase 1b Cohort 1 data for ANB033, also a CD122 antagonist, designed to block IL-15 and IL-2 signaling.
– First Tracks via GlobeNewswire
The numbers are more detailed than argenx's topline. In 32 evaluable patients (17 ANB033, 15 placebo) who took three subcutaneous doses and then a 14-day challenge of roughly 6 grams of gluten daily, Week 6 results showed a placebo-adjusted Vh:Cd improvement of +0.49 (p=0.009) and a reduction in IEL density of 20.03 (p<0.001). allSCI also reports the VCIEL composite improved by +3.33 (p=0.002).
What makes this one notable for patients is the symptom side. According to MarketChameleon, 47% of placebo patients needed permitted medications to manage GI symptoms versus just 6% on ANB033, and symptom scores diverged from the very first day of the challenge.
"It is remarkable to see, for the first time, both statistically significant prevention of symptoms and Vh:Cd benefit in the same study," the company said in its release.
Safety looked clean: no serious adverse events and no discontinuations in the ANB033 group, with fewer nausea and abdominal pain events than placebo, though injection site erythema was more common. Latent Digest notes Leerink's David Risinger called the data "impressive," and First Tracks shares rose about 7%. Keep an eye on the calendar: per American Banking News, the company plans to present Cohort 1 at ICDS in Melbourne in mid-November 2026, expects Cohort 2 (12-week mucosal healing, no gluten challenge) data in Q1 2027, and intends to start a late-stage trial in 2027.
⚖️ Three programs, one target class
Step back and the picture is a small but real pileup of CD122/IL-15-directed celiac data. Teva's TEV'408, an anti-IL-15 antibody, reported Phase 2a results on September 2, 2026: in 50 adults, the Vh:Cd change was -0.43 with TEV'408 versus -0.88 with placebo (treatment difference 0.45, p<0.05). Analysts quoted by First Tracks said ANB033's data compare "favorably" to Teva's.
The honest framing comes from Teva's own chief medical officer, Eric Hughes:
"A strict gluten-free diet has long been the only option for people living with celiac disease, yet many continue to experience symptoms and intestinal damage despite their best efforts."
That's the shared thread. All three used supervised gluten challenges, none establish long-term or repeated-dosing safety, and none suggest unrestricted gluten eating is safe. For practitioners, the useful signal is that CD122/IL-15 blockade now has multiple independent readouts pointing the same direction. For patients and parents, the honest message remains: these are investigational, and the gluten-free diet is still the only recommended management today.
🧪 Research worth bookmarking
A few studies that round out the monitoring and mechanism picture:
Blood proteins may offer new clues to gut health in celiac disease - University of Oslo researchers used proteomics on 264 blood and tissue samples to identify 24 proteins tied to celiac disease, nine linked to the extent of intestinal damage. One takeaway for anyone frustrated by "normal" blood tests: some patients still showed slightly elevated levels after a year on a gluten-free diet, hinting at residual gut inflammation. – Medical Xpress
Gliadin-specific CD4+ T cells exhibit functional diversity - This Science Advances study profiled T cells after gluten challenge and found core TCR motifs that can predict gliadin specificity, a tool for tracking the pathogenic T cells that drive the disease. – Science Advances
Beyond HLA-DQ2/DQ8: new genes linked to celiac disease - A Scientific Reports study of 376 cases and 736 controls found 18 non-HLA variants associated with celiac disease. Nothing changes at the clinic yet, but it helps explain why most DQ2/DQ8 carriers never develop the condition. – GlutenDtrotters
Celiac disease is more common than thought - A Gastroenterology study puts biopsy-confirmed celiac at 1 in 120 worldwide and seropositivity at 1 in 70, with 41% of confirmed cases asymptomatic. The practical reminder: don't go gluten-free before completing blood tests and biopsy, or you risk false negatives. – iFitness Mag
🏥 On the ground and living gluten-free
UC Health opened Southern Ohio's first dedicated adult celiac disease center on Sept. 10, 2026, in partnership with Cincinnati Children's. It's built to solve a real gap: giving kids with celiac an adult "home" when they age out of pediatric care. – The News Record
"There is no program, at least to our knowledge, in the country, that has something like this," said director Amanda Cartee. "The patients that are being treated at the children's celiac disease center now have a home to go to when they're an adult."
One everyday tool while we wait on these drugs: the Find Me Gluten Free site and app is genuinely handy for finding safe restaurants and travel options, with reviews from other celiac diners. We're not sponsored by them; it's just useful when you're navigating a menu in an unfamiliar town.
That's the issue. Two CD122 readouts in two weeks is a lot of signal, but the diet still does the heavy lifting for now. See you next time.