duvakitug (SAR447189) / Teva, Sanofi - LARVOL DELTA

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN'S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY (UEGW 2025) - P2 | "In CD patients, duvakitug demonstrated efficacy in endoscopic and patient-reported clinical outcomes in both moderate and severe endoscopic activity subgroups in this Phase 2b study. Duvakitug was well tolerated across both subgroups. These findings support further development of duvakitug as a potential treatment option for moderately to severely active CD."

Clinical • Clinical data • P2b data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFRSF25

DUVAKITUG INDUCTION TREATMENT IMPROVES CLINICAL AND ENDOSCOPIC OUTCOMES IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY (UEGW 2025) - P2 | "In UC patients, duvakitug demonstrated clinical and endoscopic efficacy and was well tolerated in both the moderate and severe endoscopic disease subgroups in this Phase 2b study. These findings support further development of duvakitug as a potential treatment option for moderately to severely active UC."

Clinical • P2b data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • TNFRSF25

STARSCAPE-2: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=671 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

SUNSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=980 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SUNSCAPE-2: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=671 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

STARSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=980 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Duvakitug, an anti-TL1a mAb, Demonstrates Efficacy and Favorable Safety as an Induction Treatment in Adults With Moderately to Severely Active Crohn's Disease: Results From the RELIEVE UCCD Phase 2b Basket Trial (ACG 2025) - P2 | "In total, 138 patients with CD were randomized, treated and included in the analysis (n=46 per arm). Demographics and baseline characteristics were similar across arms (Table 1). Both duvakitug doses achieved the primary endpoint (26% [450 mg], 48% [900 mg] vs 13% [PBO]; PBO-adjusted rates: 13% [450 mg], 35% [900 mg]) with statistically significant endoscopic responses based on the prespecified Bayesian analysis, with a >0.90 posterior probability that each duvakitug dose is superior to PBO."

Clinical • P2b data • Pan tumor • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Duvakitug, an anti-TL1a mAb, Demonstrates Efficacy and Favorable Safety as an Induction Treatment in Adults With Moderately to Severely Active Ulcerative Colitis: Results From the RELIEVE UCCD Phase 2b Basket Trial (ACG 2025) - P2 | "In total, 137 patients were randomized, treated and included in the UC cohort analysis (450 mg: n=47; 900 mg: n=46; PBO: n=44). Demographics and baseline characteristics were generally similar across arms (Table 1). Both duvakitug doses successfully achieved the week 14 primary endpoint of clinical remission (36% [450 mg], 48% [900 mg] versus 20% [PBO]; PBO-adjusted rates: 16% [450 mg], 27% [900 mg])."

Clinical • P2b data • Pan tumor • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

SUNSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=980 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

STARSCAPE-1: An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=980 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

SUNSCAPE-2: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) - P3 | N=671 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

STARSCAPE-2: A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P3 | N=671 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Duvakitug: Regulatory submission for inflammatory bowel disease in 2029 or later (Teva) - Q2 2025 Results

Filing • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

Duvakitug: Initiation of P3 trial for ulcerative colitis in Q4 2025 (Teva) - Q2 2025 Results: Initiation of P3 trial for crohn's disease in Q4 2025

New P3 trial • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

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

DUVAKITUG INDUCTION TREATMENT IMPROVES CLINICAL AND ENDOSCOPIC OUTCOMES IN MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY (DDW 2025) - P2 | No abstract available

Clinical • Late-breaking abstract • P2b data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

DUVAKITUG INDUCTION TREATMENT IMPROVES ENDOSCOPIC AND PATIENT-REPORTED CLINICAL OUTCOMES IN PATIENTS WITH CROHN'S DISEASE: AN ENDOSCOPIC SUBGROUP ANALYSIS OF DATA FROM THE RELIEVE-UCCD PHASE 2B STUDY (DDW 2025) - P2 | No abstract available

Clinical • Clinical data • P2b data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Teva Reports Ninth Consecutive Quarter of Growth in Q1 2025 With Key Innovative Medicines Growing ~40%; 2025 Profit Outlook Improved (Teva Press Release) - "We anticipate upcoming milestones for olanzapine LAI (NDA filing in 2025) and for DARI (Dual-action Asthma Rescue Inhaler; Phase 3 full enrollment in 2025 and potential Phase 3 event-driven read-out in 2026), as well the announcement of the start of the Phase 3 IBD programs for duvakitug in H2 2025."

FDA filing • New P3 trial • P3 data • Trial status • Asthma • CNS Disorders • Inflammatory Bowel Disease • Schizophrenia

Intestinal fibrosis in Crohn's disease : towards new therapeutic options? (PubMed, Rev Med Liege) - "New therapeutic strategies are emerging, including TL1A inhibitors (duvakitug, tulisokibart), an ALK5 inhibitor (AGMB-129), and targeted AGR2 therapies (TH-009). Additionally, mesenchymal stem cells are being investigated in our hospital center in combination with endoscopic balloon dilation, aiming to assess their therapeutic potential. The development of effective anti-fibrotic therapies remains a critical medical need to improve the management of intestinal strictures and reduce the need for invasive procedures in Crohn's disease."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • AGR2 • TGFBR1

Teva and Sanofi Present New Positive Phase 2b Study Results at ECCO 2025 Reinforcing Best-in-Class Potential of Duvakitug (Anti-TL1A) in Ulcerative Colitis and Crohn’s Disease (GlobeNewswire) - P2b | N=290 | RELIEVE UCCD (NCT05499130) | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | "In the UC cohort of the RELIEVE UCCD study, 36% (450 mg dose) and 48% (900 mg dose) of patients treated with duvakitug achieved the primary endpoint of clinical remission (mMS) at week 14 compared to 20% treated with placebo; placebo-adjusted rates were 16% (450 mg) and 27% (900 mg) (p=0.050 and 0.003, respectively)....In the CD cohort of the RELIEVE UCCD study, 26% (450 mg) and 48% (900 mg) of patients with CD treated with duvakitug achieved the primary endpoint of endoscopic response (SES-CD) compared to 13% on placebo; placebo-adjusted rates were 13% (450 mg) and 35% (900 mg) at week 14 (p=0.058 and <0.001, respectively)."

P2b data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Duvakitug (TEV-48574), an anti-TL1a monoclonal antibody, demonstrates efficacy and favourable safety as an induction treatment in adults with moderately to severely active ulcerative colitis: Results from a phase 2b, randomised, double-blind, placebo-controlled, dose-ranging, basket trial (RELIEVE UCCD) (ECCO-IBD 2025) - P2 | "Conclusion Duvakitug demonstrated statistically significant and clinically meaningful treatment responses compared to PBO in patients with UC; it was well tolerated with no emergent safety signals observed. These induction study results support further development of duvakitug as a potential treatment option for patients with moderately to severely active UC."

Clinical • P2b data • Pan tumor • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Duvakitug (TEV-48574), an anti-TL1a monoclonal antibody, demonstrates efficacy and favourable safety as an induction treatment in adults with moderately to severely active Crohn’s disease: results from a phase 2b, randomised, double-blind, placebo-controlled dose-ranging, basket trial (RELIEVE UCCD) (ECCO-IBD 2025) - P2 | "Duvakitug demonstrated statistically significant and clinically meaningful endoscopic response versus PBO with no emergent safety signals observed. These results support further development of duvakitug as a treatment option for patients with moderately to severely active CD."

Clinical • P2b data • Pan tumor • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Teva to Host Conference Call on February 24, 2025 to Discuss New Data Presented for Duvakitug (anti-TL1A) Positive Phase 2b results at the 20th Annual Congress of the European Crohn's and Colitis Organisation (ECCO) (Teva Press Release) - "Teva Pharmaceutical Industries...announced today that it will conduct a conference call and live webcast at 8 am E.T. on Monday, February 24, 2025. During the conference call, Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer, and external IBD key opinion leaders (KOLs) will discuss new data presented for duvakitug (anti-TL1A) positive Phase 2b results at the 20th Annual Congress of the European Crohn's and Colitis Organization (ECCO)."

P2b data • Crohn's disease • Ulcerative Colitis

Teva Delivers Second Consecutive Year of Growth; Announces Strong Financial Results in Fourth Quarter and Full Year 2024, Led by Generics Performance and Innovative Portfolio Growth (GlobeNewswire) - "Duvakitug (Anti-TL1A) positive Phase 2B results announced and initiation of Phase 3 program is expected in 2025...AJOVY revenues in our United States segment in the fourth quarter of 2024 were $63 million, an increase of 11% compared to the fourth quarter of 2023...AUSTEDO revenues in our United States segment in the fourth quarter of 2024 increased by 27%, to $518 million, compared to $408 million in the fourth quarter of 2023...UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the fourth quarter of 2024 were $43 million...COPAXONE revenues in our United States segment in the fourth quarter of 2024 were $63 million, a decrease of 13% compared to the fourth quarter of 2023, mainly due to market share erosion and competition, partially offset by a reduction in sales allowance."

Commercial • New P3 trial • CNS Disorders • Crohn's disease • Huntington's Disease • Migraine • Multiple Sclerosis • Schizophrenia

Press Release: Duvakitug positive phase 2b results demonstrate best-in-class potential in ulcerative colitis and Crohn’s disease (GlobeNewswire) - P2b | N=290 | RELIEVE UCCD (NCT05499130) | Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. | "Sanofi and Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd., today announced that the RELIEVE UCCD phase 2b study met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD)....In the RELIEVE UCCD study, 36.2% (low dose) and 47.8% (high dose) of patients with UC treated with duvakitug achieved clinical remission compared to 20.45% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14 (p=0.050 and 0.003, respectively). In patients with CD, 26.1% (low dose) and 47.8% (high dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose), at week 14 (p= 0.058 and <0.001, respectively)....Detailed results are expected to be presented at a scientific forum in 2025."

P2b data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis