Teva Pharmaceuticals and Sanofi have announced new positive data from the RELIEVE UCCD phase 2b Long-Term Extension (LTE) study in patients with moderately-to-severely active Ulcerative Colitis (UC) or Crohn’s Disease (CD), which demonstrated that duvakitug maintained clinically meaningful efficacy improvements across multiple endpoints over 44 weeks.

Duvakitug is an investigational human monoclonal antibody that targets TL1A, a protein that amplifies inflammation and potentially drives fibrosis in UC and CD.

The RELIEVE UCCD LTE study evaluated the efficacy, safety, and tolerability of duvakitug through 44 weeks of maintenance treatment after induction in patients with UC and CD, the 2 most common forms of Inflammatory Bowel Disease (IBD).

Patients (n=130, 72 with UC and 58 with CD) who responded to duvakitug treatment in the 14-week induction study were randomised to receive either duvakitug 450 mg or 900 mg subcutaneously every 4 weeks (Q4W) for up to 58 weeks of total exposure.

At week 44, maintenance treatment with duvakitug demonstrated high rates of clinical remission and clinical response, as measured by the modified Mayo Score (mMS), meaning active UC symptoms such as rectal bleeding, increased stool frequency, and pain have stopped (remission) or improved (response).

Duvakitug treatment also achieved high rates of endoscopic improvement, defined by a Mayo Endoscopic Score of 0 (inactive disease in the colon) or 1 (mild disease activity), which measures the presence and degree of intestinal inflammation. Efficacy outcomes were numerically higher at 900 mg compared to 450 mg, consistent with a dose response. 

Walter Reinisch, MD, PhD, Director--Inflammatory Bowel Disease Study Group, Medical University of Vienna and a co-lead investigator of the RELIEVE UCCD LTE study, said, “Ulcerative Colitis can have a significant impact on patients that disrupts even the most basic daily activities. Despite available therapies, some patients continue to experience flares that impact their lives in various ways and may contribute to disease progression. These results underscore the potential of duvakitug to deliver effective and durable relief from persistent inflammation and symptoms, supporting better long-term disease management in patients with Ulcerative Colitis.”

Duvakitug maintenance treatment demonstrated high rates of endoscopic response, defined as a 50 percent or more decrease from baseline in Simple Endoscopic Score for Crohn’s Disease (SES-CD) at week 44. SES-CD assesses mucosal ulcers, the ulcerated surface, the endoscopic extension, and the presence of stenosis in the colon as a gauge of disease severity. Additionally, it maintained high rates of clinical response and clinical remission as measured by the Crohn’s Disease Activity Index (CDAI), meaning symptoms such as abdominal pain, diarrhea, and fatigue have stopped (remission) or improved (response). It also appeared to demonstrate a dose response, with numerically higher efficacy results achieved at the higher dose. 

Vipul Jairath, MBChB, DPhil, FRCP, FRCPC, Professor of Medicine—Departments of Medicine, Epidemiology and Biostatistics, Western University, and a co-lead investigator of the RELIEVE UCCD LTE study, said, “Due to the heterogeneous nature of Crohn’s Disease, many patients either stop responding or never respond to available therapies, leaving them with uncontrolled symptoms that cause physical distress. The efficacy rates seen with duvakitug in the maintenance period highlight its potential as a new treatment option that could help more patients achieve sustained remission.”

Across both UC and CD, duvakitug was generally well tolerated throughout the maintenance period, with a safety profile consistent with the induction phase and no new safety concerns identified. The most frequently reported Adverse Events (AEs) occurring in ≥5 percent of patients across pooled duvakitug dose groups in UC were upper respiratory tract infection and nasopharyngitis, and in CD were upper respiratory tract infection, CD, hypertension, nasopharyngitis, anemia, and influenza. The majority of AEs were mild or moderate in severity. Discontinuation rates due to AEs were low (UC, 4 percent and 2 percent in the 450 mg and 900 mg arms, respectively, and in CD were 6 percent in each arm).