Teva’s TEV-408 Hits Key Phase IIa Endpoint in Celiac Disease Study

Key Points

• TEV-408 met its primary Phase IIa endpoint in a 50-patient celiac disease gluten-challenge study, significantly reducing biopsy measures of intestinal damage and inflammation versus placebo.
• The single-dose treatment was reportedly well tolerated, with no concerning safety signals; Teva said the antibody may support dosing approximately once every three months based on earlier data.
• Teva plans to discuss the results with regulators before designing a larger Phase II program focused on dose-ranging, longer exposure and symptom outcomes. The company also intends to advance TEV-408 in vitiligo and potentially other IL-15-related conditions.

Teva Pharmaceutical Industries NYSE: TEVA reported positive topline results from a Phase IIa gluten-challenge study of TEV-408, its anti-IL-15 antibody candidate for celiac disease, with the company saying the treatment met its primary endpoint and showed statistically significant effects on key measures of intestinal damage.

The randomized study enrolled 50 adults with celiac disease, assigning participants one-to-one to TEV-408 or placebo. Patients received a single dose on day one, followed two weeks later by a six-week gluten challenge of 3 grams per day, an amount Teva described as roughly equivalent to a slice of standard bread.

According to Eric Hughes, Teva’s executive vice president of global R&D and chief medical officer, the study evaluated the ratio of villous height to crypt depth, a biopsy-based measure of intestinal injury in celiac disease. The placebo group saw its ratio decline by 0.88, compared with a 0.43 decline in the TEV-408 group, producing a treatment-placebo difference of 0.45.

Hughes said the 0.4 threshold is considered clinically meaningful and that the primary endpoint was statistically significant. The company also reported a statistically significant result on intraepithelial lymphocytes, immune cells associated with inflammation and intestinal damage in celiac disease. The placebo group experienced an increase of 27.6 cells per 100 enterocytes, while the TEV-408 group saw little change, resulting in a reported delta of 27.23.

Single-Dose Study and Safety Profile

Teva said the study’s results followed only one dose of TEV-408, despite the antibody’s potential dosing schedule of once every three months. Hughes said Phase I data showed an approximately 38-day half-life and suppression of free IL-15 to essentially below detectable levels for 80 to 90 days at higher tested doses.

The company characterized the treatment as well tolerated to date, with no concerning safety signals identified across its development program. Teva said it has conducted a Phase I program involving 115 participants with follow-up extending to two years, in addition to an earlier Phase Ib celiac disease challenge study and clinical data in vitiligo.

In the prior celiac study, Teva observed changes in fatty acid-binding protein, a biomarker associated with gut inflammation. Hughes said those results suggested TEV-408 may have protected the gut from gluten exposure and potentially affected underlying “smoldering” disease activity.

TEV-408 has received Fast Track designation in celiac disease, Hughes said. Teva plans to present the new data to the U.S. Food and Drug Administration and other regulators to determine the next stage of development.

Next Steps in Celiac Disease Development

Hughes said future Phase II work is expected to include dose-ranging of TEV-408 itself, longer treatment exposure and further evaluation of both biopsy findings and patient-reported symptoms. Teva used the Celiac Disease Symptom Diary in the Phase IIa study and reported a trend toward protection from symptoms including abdominal pain, diarrhea, nausea, bloating and fatigue.

The company did not provide timing for the next celiac Phase II study or a subsequent Phase III program, saying those plans will depend on discussions with regulators. Hughes said Teva is considering studies involving lower-level, simulated inadvertent gluten exposure for longer-duration trials, rather than the more intensive gluten challenge used in the proof-of-concept study.

On longer-term safety requirements, Hughes said programs generally require approximately 300 patients with six months of exposure and a total safety database of roughly 1,000 to 1,400 patients, while noting that final requirements could vary.

Teva said it also plans to develop TEV-408 in vitiligo through a seamless Phase II/III design expected to begin this year. The company may later consider additional IL-15-mediated conditions, including alopecia areata, eosinophilic esophagitis and potentially atopic dermatitis.

Broader Pipeline Strategy

President and CEO Richard Francis said the TEV-408 results represent progress in Teva’s “Pivot to Growth” strategy, which aims to expand the company’s innovative medicines portfolio alongside its generics business. Francis said Teva sees an opportunity for five product submissions over five years and that its highlighted programs and indications have the potential to generate more than $10 billion in sales over time.

Francis said Teva does not currently plan to partner TEV-408, citing its commercial capabilities and its ability to fund development across multiple indications. He also highlighted upcoming milestones, including completion of the DARI asthma study, a futility analysis for emrusolmin, a potential fourth-quarter launch of long-acting olanzapine and a planned early-2027 ecopipam launch following priority review.

About Teva Pharmaceutical Industries (NYSE:TEVA)

Teva Pharmaceutical Industries Ltd. NYSE: TEVA is an Israeli multinational pharmaceutical company and one of the world's largest manufacturers of generic medicines. The company's core activities include the development, production and marketing of generic pharmaceuticals alongside a portfolio of specialty branded medicines. Teva supplies finished dosage forms and active pharmaceutical ingredients (APIs) to markets around the globe and operates manufacturing and research facilities in multiple countries.

Teva's product range covers oral solids, injectables, inhalation products and other dosage forms across therapeutic areas such as central nervous system disorders, respiratory, oncology, pain and infectious disease.

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