Teva Pharmaceutical Industries Limited · TASE:TEVA
Teva Pharmaceutical Industries — ECCO 2025 investor call
28 slides from Teva Pharmaceutical Industries's conference presentation, Feb 24, 2025
Slide 1: Duvakitug (Anti-TL1A) Phase 2 – Investors Call to Discuss New Data Presented at ECCO
Teva Pharmaceutical Industries Ltd. Duvakitug (Anti-TL1A) Phase 2 – Investors Call to Discuss New Data Presented at ECCO February 24, 2025
Slide 2: Forward-looking statements
This presentation 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 futu
Slide 3: Executive Vice President, Global R&D & Chief Medical Officer
Executive Vice President, Global R&D & Chief Medical Officer 3|
Slide 4: Asset, phase, indication and next milestones
Asset Phase Indication Progress Next milestones and expected timing olanzapine LAI Achieved Phase III targeted Long term study III Schizophrenia H1 2025 TEV-’749 injections without PDSS full safety presentation DARI (ICS/SABA) Phase III adults & pediatrics H2 2026 III Asthma Phase III results TEV-’2
Slide 5: Large Unmet Need for Patients in Inflammatory Bowel Disease (IBD)
Large Unmet Need Chronic inflammation of the gastrointestinal tract caused by an abnormal immune response for Patients in to gut microflora Inflammatory Bowel Disease (IBD) • 2.3M Ulcerative Colitis and 1.8M Crohn’s Disease patients diagnosed • <50% patients achieve clinical remission, and responsiv
Slide 6: TL1A role in inflammation and diseases
TL1A Producing Cells Target Cells Example diseases where Marketed Products Inflammation TL1A may have a role None approved for all implicated therapeutic areas IFN-γ, TNF • Crohn’s Disease Stelara® TLR • Ulcerative colitis (ustekinumab) stimulation IL-4, IL-13, IL-5 • Rheumatoid arthritis dendritic
Slide 7: TL1A binds to two receptors; Teva antibody blocks DR3 and not DcR3
TL1A binds to two receptors and Teva antibody strategically designed to block DR3 and not DcR3 DR3 receptor Desirable to block DcR3 decoy receptor Desirable to retain Involved in pro- Regulates excess inflammatory TL1A, maintaining signaling natural homeostasis 7|
Slide 8: RELIEVE UCCD Phase 2b study design
High-Dose Duvakitug Q2W SC** Primary Endpoints: N = ~240 (~120 each) Loading Dose (SC)* Primary Endpoint N=~40 (each in UC & CD) Extension Trial Randomization • UC: Clinical remission per Long-Term UC & CD Low-Dose Duvakitug Q2W SC Modified Mayo Score N=~40 (each in UC & CD) (mMS) Placebo • CD: Endo
Slide 9: Professor, Division of Gastroenterology, Western University
Professor - Department of Medicine Division of Gastroenterology, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. 9|
Slide 10: 99% of Participants Treated with Duvakitug Completed the Trial
99% of Participants Treated with Duvakitug* Completed the Trial Randomized and treated (mITT) N=137 Placebo Duvakitug 450 mg Duvakitug 900 mg N=44 N=47 N=46 Discontinued treatment Discontinued treatment Discontinued treatment N=5 (11%) N=0 (0%) N=1 (2%) Primary reason: Primary reason: • Adverse even
Slide 11: UC baseline demographics and characteristics
Placebo Duvakitug 450 mg Duvakitug 900 mg Overall N=44 N=47 N=46 N=137 Age, years, mean (SD) 42.2 (13.1) 38.7 (13.0) 42.1 (13.2) 41.0 (13.1) Male, n (%) 30 (68) 29 (62) 27 (59) 86 (63) BMI, mean (SD) 26.4 (6.3) 25.4 (5.7) 24.8 (3.9) 25.6 (5.4) Geographic region, n (%) North America 3 (7) 4 (9) 2 (4)
Slide 12: Significantly Higher Clinical Remission in Both Duvakitug Doses
Significantly Higher Proportion of Participants in Both Duvakitug Doses Achieved Clinical Remission 60% 27%* Duvakitug Duvakitug 50% 48% 450 mg 900 mg 16%* vs. PBO vs. PBO Clinical Remission (%) 40% 36% Posterior probability† 0.95* >0.99* 30% 20% 20% Odds ratio‡ 2.2 3.6 10% p-value=0.050 p-value=0.0
Slide 13: Clinical Remission Irrespective of Prior AT Experience
Higher Clinical Remission Rates Were Observed for Both Doses of Duvakitug Versus Placebo Irrespective of Prior AT Experience 27%* 26% 60% 53% 50% 48% 29% 16%* 12% 39% Clinical Remission (%) 40% 22% 36% 36% Placebo 29% 28% 30% Duvakitug 450 mg 20% Duvakitug 900 mg 20% 10% 7% 9/44 17/47 22/46 1/15 4/1
Slide 14: Additional Clinical, Endoscopic and Histological Endpoints
Higher Responses Across Additional Clinical, Endoscopic and Histological Endpoints Were Achieved with Both Doses of Duvakitug Versus Placebo 100% 81% Proportion of Participants (%) 80% Placebo 70% Duvakitug 450 mg 60% 52% 50% Duvakitug 900 mg 45% 40% 33% 30% 23% 20% 16% 23/44 38/47 32/46 10/44 21/47
Slide 15: UC safety summary
Duvakitug Duvakitug Placebo 450 mg 900 mg Category, n (%) N=44 N=47 N=46 Participants with any treatment-emergent AE 23 (52) 23 (49) 20 (43) Treatment-related AEs 2 (5) 3 (6) 6 (13) Serious AEs† 1 (2) 0 1 (2) AEs leading to discontinuation‡ 2 (5) 0 1 (2) Death 0 0 0 Participants with AESI*§ 2 (5) 2
Slide 16: Common adverse events in UC
(>2 participants in any treatment arm) Duvakitug Duvakitug Placebo 450 mg 900 mg Adverse Event, n (%) N=44 N=47 N=46 Upper respiratory tract infection 1 (2) 3 (6) 1 (2) Nasopharyngitis 1 (2) 3 (6) 0 Vomiting 0 3 (6) 0 Anaemia 3 (7) 1 (2) 1 (2) • These AEs were non-serious and self-limited 16 |
Slide 17: UC conclusions
• Duvakitug induction therapy demonstrated statistically significant clinical remission rates versus placebo with an effect size up to 27% in participants with moderately to severely active UC • Additional clinical and endoscopic endpoints supported the efficacy of duvakitug in this population • Duv
Slide 18: Over 85% of Participants Treated with Duvakitug Completed the Trial
Over 85% of Participants Treated with Duvakitug* Completed the Trial Randomized and treated (mITT) N=138 Placebo Duvakitug 450 mg Duvakitug 900 mg N=44 N=46 N=46 Discontinued treatment Discontinued treatment Discontinued treatment N=9 (20%) N=9 (20%) N=3 (7%) Primary reason: Primary reason: Primary
Slide 19: Crohn's disease baseline demographics and characteristics
Placebo Duvakitug 450 mg Duvakitug 900 mg Overall N=46 N=46 N=46 N=138 Age, years, mean (SD) 38.3 (15.1) 42.5 (15.1) 37.8 (13.6) 39.5 (14.7) Male, n (%) 22 (48) 27 (59) 31 (67) 80 (58) BMI, mean (SD) 24.9 (6.8) 24.6 (5.0) 26.2 (6.2) 25.2 (6.0) Geographic region, n (%) North America 11 (24) 11 (24) 1
Slide 20: Significantly Higher Endoscopic Response in Both Dose Groups
Significantly Higher Proportion of Participants in Both Duvakitug Dose Groups Achieved Endoscopic Response 60% 35%* Duvakitug Duvakitug 50% 48% 450 mg 900 mg vs. PBO vs. PBO Endoscopic Response (%) 40% 13%* Posterior probability† 0.94* >0.99* 30% 26% 20% 13% Odds ratio‡ 2.4 6.1 10% p-value=0.058 p-v
Slide 21: Endoscopic Response Irrespective of Prior AT Experience
Higher Endoscopic Response Rates Were Observed for Both Doses of Duvakitug Versus Placebo Irrespective of Prior AT Experience; Response Rates Were Consistent for Duvakitug 900 mg 25% 60% 35%* 44% 25% 50% 48% 48% 47% 47% Endoscopic Response (%) 40% 13%* Placebo 30% 26% Duvakitug 450 mg 23% Duvakitug
Slide 22: Additional Clinical and Endoscopic Endpoints in CD
Higher Responses Across Additional Clinical and Endoscopic Endpoints Were Achieved with Both Duvakitug Doses Versus Placebo 80% Placebo Duvakitug 450 mg Proportion of Participants (%) Duvakitug 900 mg 61% 62% 60% 54% 53% 50% 50% 41% 41% 40% 29% 26% 20% 17% 9% 4/46 8/46 12/46 19/46 23/46 25/46 17/41
Slide 23: CD safety summary
Duvakitug Duvakitug Placebo 450 mg 900 mg Category, n (%) N=46 N=46 N=46 Participants with any treatment-emergent AE 22 (48) 31 (67) 20 (43) Treatment-related AEs 2 (4) 6 (13) 6 (13) Serious AEs 5 (11) 6 (13) 1 (2) AEs leading to discontinuation 1 (2) 4 (9) 1 (2) Death 0 0 0 Participants with AESI*
Slide 24: Common adverse events in CD
(>2 participants in any treatment arm) Duvakitug Duvakitug Placebo 450 mg 900 mg Adverse Event, n (%) N=46 N=46 N=46 Anaemia 1 (2) 3 (7) 0 Headache 1 (2) 4 (9) 1 (2) Nasopharyngitis 3 (7) 2 (4) 3 (7) • These AEs were non-serious and self-limited 24 |
Slide 25: CD conclusions
• Duvakitug induction therapy demonstrated statistically significant and clinically impactful endoscopic response rates versus placebo in participants with moderately to severely active CD • Additional clinical and endoscopic endpoints supported the primary endpoint of endoscopic response observed w
Slide 26: Statistically Significant and Clinically Meaningful Responses in UC and CD
Statistically Significant and High Potency in vitro1 Clinically High Selectivity1 Meaningful Responses Low Anti-Drug Antibodies Observed in Phase 2 for Both Rapid, Profound, and Prolonged Suppression of Free TL1A2 Ulcerative Colitis and Crohn's Consistent Favorable Safety and Tolerability To Date Di
Slide 27: Q&A
O&A 3
Slide 28: Slide 28
Teva Pharmaceutical Industries — ECCO 2025 investor call on 6ix