AZD7798 / AstraZeneca - LARVOL DELTA

FEASIBILITY AND BASELINE CHARACTERISTICS FROM THE CALLISTO PHASE II STUDY OF CROHN'S DISEASE PATIENTS WITH AN ILEOSTOMY: A POPULATION PREVIOUSLY EXCLUDED FROM INTERVENTIONAL CLINICAL TRIALS (UEGW 2026) - P2 | "AZD7798 is a first-in-class therapeutic antibody that depletes CCR9+ lymphocytes, with potential for targeted treatment of ileal inflammation in CD... This baseline analysis represents the first systematic characterization of CD patients with an ileostomy within a prospective interventional trial. The data demonstrate that recruitment and assessment strategies need to account for substantial discordance between clinical symptoms and biomarkers, and endoscopically visible mucosal inflammation. Importantly, serial ileoscopies and stoma-based biomarker sampling were feasible, supporting the conduct of mechanistically focused trials in this setting."

Clinical • P2 data • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Mucositis

CHANGES IN INTESTINAL CCR9+ AFTER REPEATED DOSING OF AZD7798: PHASE IB PET (EUROPA) STUDY IN PATIENTS WITH CROHN'S DISEASE (UEGW 2026) - P1 | "Five PET/CT examinations using the CCR9-specific radioligand [11C]vercirnon were performed (baseline, Week 13, 16, 20 and 24).The primary imaging endpoint was change from baseline in ileum partition coefficient (Kp), defined as the standard uptake value ratio between the target intestinal region and the abdominal aorta as a reference region. In this Ph1b PET study, AZD7798 was well tolerated. Reduced CCR9+ PET signal in the ileum was observed, aligned with near‑complete depletion and receptor occupancy of CCR9+ T cells in blood. These results were consistent with the proposed mechanism of action of AZD7798 and support further clinical evaluation in Crohn's disease, particularly in patients with small bowel involvement."

Clinical • P1 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

AZD7798: Data from P2a AMALTHEA trial (NCT06450197) for moderate-to-severe Crohn’s disease in H2 2026 (AstraZeneca) - H1 and Q2 2026 Results: Data from P2 CALLISTO trial (NCT06681324) for active ileal Crohn's disease and an ileostomy in H2 2026

P2 data • P2a data • Crohn's disease • Inflammatory Bowel Disease

AMALTHEA: Phase IIa Study Evaluating AZD7798 in Crohn's Disease (clinicaltrials.gov) - P2 | N=192 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

AMALTHEA: Phase IIa Study Evaluating AZD7798 in Crohn's Disease (clinicaltrials.gov) - P2 | N=192 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

AMALTHEA: Phase IIa Study Evaluating AZD7798 in Crohn's Disease (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=192 ➔ 120

Enrollment change • Enrollment closed • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

CALLISTO: Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

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

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2026 ➔ Apr 2026 | Trial primary completion date: Aug 2026 ➔ Apr 2026

Enrollment closed • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

CALLISTO: Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: AstraZeneca | Trial primary completion date: Jan 2026 ➔ May 2026

Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

CALLISTO: Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Feb 2027 ➔ Jun 2027

Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

AZD7798, A MONOCLONAL ANTIBODY DEPLETING CCR9+ T CELLS, WITH THE POTENTIAL TO TARGET HARD-TO-TREAT SMALL BOWEL CROHN'S DISEASE (DDW 2025) - P1 | "CCR9 is identified as an attractive target for small bowel-dominant inflammation. AZD7798, a first-in-class CCR9+ T cell depleting antibody, demonstrated acceptable safety and tolerability alongside sustained CCR9+ T cell reductions in blood and small intestine."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Imaging of CCR9 in the small bowel of patients with Crohn’s disease: effects of the CCR9-depleting monoclonal antibody AZD7798 (ECCO-IBD 2025) - P1 | "Here we use positron emission tomography (PET) with a novel CCR9-specific PET tracer, [ 11 C]vercirnon, to assess the ability of AZD7798 to deplete CCR9+ cells in the intestines of healthy volunteers and patients with SBCD. The study demonstrates the value of molecular imaging for understanding treatment effect in the target tissue in vivo . An ongoing PET imaging study will assess the effects of AZD7798 on CCR9+ cell depletion/repletion in the gut following multiple doses, alongside Phase 2 studies evaluating the clinical efficacy of AZD7798 in moderate-to-severe Crohn’s disease."

Clinical • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease

AZD7798, a monoclonal antibody depleting CCR9+ T cells, with the potential to target hard-to-treat small bowel Crohn’s disease (ECCO-IBD 2025) - P1 | "CCR9 is identified as an attractive target for small bowel-dominant inflammation. AZD7798, a first-in-class CCR9+ T cell depleting antibody, demonstrated acceptable safety and tolerability alongside sustained CCR9+ T cell reductions in blood and small intestine."

Crohn's disease • Immunology • Inflammatory Bowel Disease

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2026 ➔ Aug 2026 | Trial primary completion date: Mar 2026 ➔ Aug 2026

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease (clinicaltrials.gov) - P1 | N=112 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Nov 2024

Trial completion • Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

CALLISTO: Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AstraZeneca | N=24 ➔ 12

Enrollment change • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

CALLISTO: Study Evaluating AZD7798 for Treatment in Crohn's Disease Patients With an Ileostomy (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • CRP

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

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

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease (clinicaltrials.gov) - P1 | N=11 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

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

AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease (clinicaltrials.gov) - P1 | N=106 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

AZD7798 Safety, Tolerability, and Pharmacokinetics After a Single Ascending and Repeat Dose Administrations to Healthy Subjects, and Patients With Crohn's Disease (clinicaltrials.gov) - P1 | N=144 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Sep 2024 ➔ Aug 2025

Trial completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Patients With Crohn's Disease. (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease