Teva Announces Positive Topline Results from Phase 2a Study in Celiac Disease for Its Anti-IL-15 Antibody, Further Validating Its Pipeline-in-a-Product Potential
Teva (TEVA) reported positive topline Phase 2a results for TEV ‘408, its investigational anti-IL-15 monoclonal antibody in adults with celiac disease on a gluten-free diet.
Rhea-AI Summary
Teva (TEVA) reported positive topline Phase 2a results for TEV ‘408, its investigational anti-IL-15 monoclonal antibody in adults with celiac disease on a gluten-free diet.
The randomized, placebo-controlled study enrolled 50 participants who received a single subcutaneous dose of TEV ‘408 followed by a six-week daily gluten challenge. The trial met its primary endpoint at week 8, showing statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo, with an LS mean change in villous height-to-crypt depth ratio of -0.43 for TEV ‘408 versus -0.88 for placebo (treatment difference 0.45; 95% CI: 0.06–0.84; p<0.05). The drug also showed a favorable effect on intestinal inflammation, with IEL density increasing 27.60 in placebo versus 0.37 in TEV ‘408 (treatment difference -27.23; 95% CI: -39.67 to -14.79), and demonstrated lower GI symptom scores versus placebo.
TEV ‘408 was well-tolerated with no emerging safety signals. The asset holds FDA Fast Track designation in celiac disease and is also progressing in vitiligo, supported by a funding agreement with Royalty Pharma of up to $500 million to accelerate development.
Positive
- Primary endpoint met: TEV ‘408 prevented gluten-induced intestinal damage vs placebo with LS mean Vh:Cd change -0.43 vs -0.88 (difference 0.45; p<0.05)
- Intestinal inflammation reduced: IEL density increased 27.60 with placebo vs 0.37 with TEV ‘408 (difference -27.23; 95% CI: -39.67, -14.79)
- Symptom improvement: Lower GI symptom scores with TEV ‘408 vs placebo on the Celiac Disease Symptom Diary
- Favorable safety: TEV ‘408 was well-tolerated with no emerging safety signals to date
- Regulatory support: TEV ‘408 has FDA Fast Track designation for celiac disease
- Development funding: Teva may receive up to $500 million from Royalty Pharma to accelerate TEV ‘408 clinical development
Negative
- Early-stage data: Results are from an ongoing Phase 2a trial, with additional analyses still underway
- Small study size: The Phase 2a trial enrolled 50 adult participants, limiting the dataset
- No approved therapy yet: TEV ‘408 remains investigational for celiac disease and vitiligo
News Explained
The Phase 2a celiac-disease study remains ongoing: Teva reported topline results, while additional analyses are underway and further data are planned for presentation at a future scientific meeting.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 19 | FDA review acceptance | Positive | +2.5% | FDA accepted ecopipam's NDA and granted Priority Review for pediatric Tourette syndrome. |
| Feb 20 | NDA acceptance | Positive | -0.3% | FDA accepted TEV-'749's NDA for once-monthly schizophrenia treatment. |
| Dec 09 | NDA submission | Positive | +0.8% | Teva submitted an NDA for once-monthly olanzapine injectable suspension. |
| Sep 20 | Phase 3 safety data | Positive | +2.8% | Long-term SOLARIS data reported no post-injection delirium or sedation syndrome events. |
| Sep 09 | Fast Track designation | Positive | +2.0% | FDA granted Fast Track designation to emrusolmin for multiple system atrophy. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
TEVA's tag-specific clinical-trial news was aligned with positive reactions in four of five events, with one divergence.
Key Terms
monoclonal antibody medical
least squares technical
fast track designation regulatory
cytokine medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Teva-discovered TEV ‘408, a novel anti-IL-15 monoclonal antibody, demonstrated statistically significant and clinically meaningful prevention of gluten-induced intestinal damage vs placebo following a single subcutaneous dose.
- TEV ‘408 was well-tolerated with no safety signals observed to date.
- Together with the vitiligo program, the celiac disease topline results further support TEV ‘408 as a potential pipeline-in-a-product opportunity in multiple diseases.
Teva will hold an investor call and live webcast today,
Wednesday, September 2, 2026, at 8:00 a.m. ET to discuss these data.
TEL AVIV, Israel, Sept. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from an ongoing Phase 2a study of TEV ‘408, an investigational anti-interleukin-15 monoclonal antibody, in adults with celiac disease. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8. TEV ‘408 was well-tolerated, with no safety signals observed to date.
“A strict gluten-free diet has long been the only option for people living with celiac disease. Yet, even with strict adherence to a gluten-free diet, many continue to experience symptoms, intestinal damage and a significant impact on their daily lives,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. “These results underscore the potential to move beyond managing gluten exposure and address celiac disease at its biological source. They also strengthen our confidence in targeting the IL-15 pathway as an approach to reducing immune-driven intestinal damage.”
The ongoing randomized, placebo-controlled study enrolled 50 adult participants with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage at baseline as measured by the villous height-to-crypt depth ratio (Vh:Cd ≥2.0) and symptoms. Two weeks after receiving a single dose of TEV ‘408, participants began a six-week daily gluten challenge (GC). The study assessed biopsy-based measures of intestinal damage and inflammation along with patient-reported symptoms. At week 8 (the end of the GC) TEV ‘408:
- Showed statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo, as measured by the trial’s primary endpoint of Vh:Cd ratio with a least squares (LS) mean change from baseline of -0.43 compared with -0.88 for placebo (treatment difference of 0.45,
95% CI: (0.06, 0.84), p<0.05). - Showed a favorable effect on intestinal inflammation as measured by density of intraepithelial lymphocytes (IELs) compared with placebo; the LS Mean change from baseline in the density of IELs, was an increase of 27.60 for placebo compared to 0.37 for TEV ‘408 treated participants (treatment difference of -27.23,
95% CI: (-39.67, -14.79)). - Demonstrated lower GI symptom scores versus placebo, as assessed using the Celiac Disease Symptom Diary (CDSD), a patient-reported outcome (PRO).
- Was well-tolerated with no emerging safety signals.
Additional analyses from the ongoing Phase 2a study are underway. Teva plans to present further data from the study at a future scientific meeting.
Teva Investor Call
Teva will hold an investor call and live webcast today, Wednesday, September 2, 2026, at 8:00 a.m. ET/ 2:00 p.m. CET to discuss these data. To participate, please register in advance here. To access a live webcast of the presentation, visit Teva’s Investor Relations website. An archived version of the webcast will be available 24 hours after the end of the live discussion.
About TEV ‘408
TEV ‘408, discovered by Teva, is an investigational human monoclonal antibody designed to inhibit interleukin-15 (IL-15), a cytokine involved in immune-mediated pathways. TEV ‘408 has a high affinity and potency (in vitro) with a prolonged half-life that supports the potential for convenient subcutaneous dosing.
TEV ‘408 is being studied as a potential therapy for celiac disease in a Phase 2a study and was granted Fast Track designation in that indication by the U.S. FDA in May 2025. By blocking IL-15 activity, TEV ‘408 aims to reduce the IL-15-driven intestinal inflammation and damage that are characteristic of celiac disease.
TEV ‘408 is also being evaluated in a Phase 1b study as a treatment for vitiligo. Following encouraging results from the ongoing Phase 1b study in vitiligo, Teva is advancing the investigational asset into a Phase 2b study in vitiligo. By blocking IL-15 activity, TEV ‘408 aims to reduce the immune-mediated destruction of melanocytes (pigment-producing cells) resulting in white patches on the skin characteristic of vitiligo.
Teva entered a strategic funding agreement with Royalty Pharma in January 2026. Under the agreement, Teva is eligible to receive up to
About Celiac Disease
Celiac disease is a serious autoimmune disease in which exposure to gluten triggers an immune response that damages the small intestine. It affects approximately
There are currently no approved therapies for celiac disease. A strict gluten-free diet (GFD) remains the standard of care, yet even with careful adherence, patients may continue to experience symptoms, reduced quality of life, and ongoing intestinal inflammation or damage due to inadvertent gluten exposure. For people living with celiac disease, managing the condition often requires constant vigilance around meals, travel, work, and social activities, creating significant daily burden. The limitations of current management approaches underscore the need for therapies that address the underlying drivers of disease and improve outcomes for patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize TEV-’408 for the treatment of celiac disease and for the treatment of vitiligo; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize our innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors,” and “Forward-Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Teva Media Inquiries: TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries: TevaIR@Tevapharm.com
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