TEV-'408 / Teva, Royalty - LARVOL DELTA

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 (GlobeNewswire) - "The study met its primary endpoint, demonstrating statistically significant and clinically meaningful prevention of gluten-induced intestinal damage versus placebo at week 8.....The ongoing randomized, placebo-controlled study enrolled 50 adult participants with celiac disease on a gluten-free diet (GFD)....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)....Teva plans to present further data from the study at a future scientific meeting."

P2a data • Celiac Disease

Teva Pharmaceutical announced today that it will advance TEV-’408, its investigational anti-interleukin-15 (IL-15) monoclonal antibody, into a phase 2b clinical trial in patients with non-segmental vitiligo (NSV) during the fourth quarter of 2026 (DermatologyTimes) - “Among evaluable participants at week 24, TEV-'408 demonstrated improvements across multiple clinician- and patient-reported outcomes, including: Nearly 75% of patients reported improvement in facial vitiligo; Approximately 50% described their facial vitiligo as 'much improved' or 'very much improved'; 42% achieved F-VASI50; 21% achieved F-VASI75; 55% reported improvement in total body vitiligo; 7% achieved T-VASI50....The phase 2b study is expected to further evaluate TEV-'408 in a larger population of patients with non-segmental vitiligo following the encouraging phase 1b findings."

New P2b trial • P1 data • Immunology • Vitiligo

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D LLC | Trial primary completion date: May 2026 ➔ Sep 2026

Trial primary completion date • Dermatology • Immunology • Vitiligo

First Quarter 2026 and Recent Business Highlights:…TEV- '408 (Businesswire) - "Topline results of the Phase 1b trial evaluating TEV-'408 for vitiligo are expected in the first half of this year. Topline results of the Phase 2a trial evaluating TEV-'408 for celiac disease are expected in the second half of this year."

P1 data • P2a data • Celiac Disease • Immunology • Vitiligo

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D LLC | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Celiac Disease • Immunology

TEV- '408 (Businesswire) - "Topline results of the Phase 1b trial evaluating TEV-'408 for vitiligo are expected in the first half of this year. Topline results of the Phase 2a trial evaluating TEV-'408 for celiac disease are expected in the second half of this year."

Clinical data • Celiac Disease • Vitiligo

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Vitiligo

Innovative late-stage pipeline continued to drive transformation (Teva Press Release) - "4 innovative product submissions targeted over the next 5 years. Up to $500 million in funding secured via Teva’s agreement with Royalty Pharma to fund the development of anti-IL-15 (TEV-’408) for vitiligo indication. duvakitug (anti-TL1A) Phase 3 initiated for ulcerative colitis and Crohn's disease. Preparing for olanzapine LAI U.S. launch, subject to regulatory approval; New Drug Application (NDA) submitted to FDA in December 2025."

Financing • Launch US • Trial status • Crohn's disease • Schizophrenia • Ulcerative Colitis • Vitiligo

Teva Reaffirms “Pivot to Growth” Strategy Progress with Launch of Acceleration Phase at 2025 Innovation and Strategy Day (Teva Press Release) - "AUSTEDO: Expected to exceed $2.5 billion in sales by 2027 and exceed $3 billion by 2030. AJOVY: A globally established brand with presence across 43 countries and expected launches in 3 additional countries this year....duvakitug (anti-TL1A): A potentially best-in-class treatment for inflammatory bowel disease, with potential expansion into additional indications with peak sales potential of up to $2-$5 billion. DARI: A dual-action rescue inhaler for asthma, that could address a significant unmet need as a first ICS/SABA combination for both adult and pediatric patient populations, with peak sales potential of ~$1 billion....emrusolmin: A potential first-in-class treatment for Multiple System Atrophy (MSA), a rare and fatal neurodegenerative disease that currently has no approved treatments, with peak sales potential of more than $2 billion. TEV-‘408...with peak sales potential of more than $1 billion."

Launch • Sales projection • Asthma • Crohn's disease • Huntington's Disease • Inflammatory Bowel Disease • Migraine • Multiple System Atrophy

Teva Celiac Disease Candidate Granted Fast Track Designation by US FDA (GlobeNewswire) - "Teva Pharmaceutical Industries...announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease."

Fast track • Celiac Disease

Modeling human natural killer cell development and drug response in a microfluidic bone marrow model. (PubMed, Front Immunol) - "The effect of an anti-IL-15 monoclonal antibody (TEV-53408) on different NK cell subtypes was tested at different time points...This effect was partially reversible after a two-week treatment-free period. In summary, the presented model enables investigation of human NK cell development in the bone marrow and provides a basis to study related diseases and drug response effects in a microenvironment that is designed mimic human physiology."

Journal • IL15

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Celiac Disease • Immunology

A Trial to Assess the Efficacy and Safety of TEV-53408 in Adults With Celiac Disease (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

New P2 trial • Celiac Disease • Immunology

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Vitiligo

Anti-IL-15 neutralizing antibody counteracts vitiligo in a humanized mouse model (EADV 2024) - "TEV-53408 is a potent and specific neutralizing antibody, that has demonstrated on-target efficacy in a vitiligo hIL- 15KI mouse model. These findings support the rationale for clinical development of this novel IL-15 antagonist as a treatment for vitiligo."

Preclinical • Dermatology • Immunology • Vitiligo • CD8 • IFNG • IL15 • Tyrosinase

Anti-IL-15 neutralizing antibody counteracts vitiligo in a humanized mouse model (EADV 2024) - "TEV-53408 is a potent and specific neutralizing antibody, that has demonstrated on-target efficacy in a vitiligo hIL- 15KI mouse model. These findings support the rationale for clinical development of this novel IL-15 antagonist as a treatment for vitiligo."

Preclinical • Dermatology • Immunology • Vitiligo • CD8 • IFNG • IL15 • Tyrosinase

A Trial to Test the Safety and Efficacy of TEV-53408 in Treating Vitiligo (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

New P1 trial • Dermatology • Immunology • Vitiligo

DEVELOPING TEV-53408 FOR THE TREATMENT OF CELIAC DISEASE: SUMMARY OF PRELIMINARY RESULTS FROM THE FIRST IN HUMAN PHASE 1 STUDY IN HEALTHY VOLUNTEERS (DDW 2024) - "Single doses of TEV-53408 appear to be safe and well tolerated. TEV-53408 appears to engage its target as demonstrated by reduced serum IL-15 levels and NK cell counts. There may be a floor effect in the effect of TEV-53408 on NK cells."

Clinical • P1 data • Celiac Disease • Gastrointestinal Disorder • Immunology • IL15

Evaluating the Functional Capability of Circulating Natural Killer Cells in Human Studies (IMMUNOLOGY 2024) - "The collected data demonstrated a standard CD56 bright:dim ratio at all time points. Perforin load (MFI) and % of CD107a expression with or without stimulation suggest that TEV-53408 had no effect on the degranulation ability of NK cells.These assessments provide an effective method to assess the phenotype and functionality of remaining NK cells following anti-IL-15 treatment. The results suggest that treatment with TEV-53408 does not affect the functionality of the remaining NK cells during the studied timeframe, despite the reduction of circulating NK cells."

IL15 • LAMP1 • NCAM1