AZD7798 / AstraZeneca - LARVOL DELTA

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

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

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

First-time-in-human visualisation of CCR9 expression in the gut by positron emission tomography (SNMMI 2024) - P1 | "To address this need, we have developed a CCR9-specific PET tracer based on the small molecule CCR9 antagonist vercirnon. We have developed a CCR9-specific PET tracer which potentially enables repeatable quantification of CCR9 expression in the gut. Ongoing studies will use the PET tracer assess the effects of AZD7798 on CCR9+ cell depletion/repletion in the gut, providing critical data to support the clinical development programme."

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

TOLERABILITY, SAFETY, AND CLINICAL PHARMACOLOGY OF AZD7798, A DEPLETING ANTIBODY TARGETING CCR9 (DDW 2024) - P1 | "ConclusionThese observations in humans are consistent with pre-clinical studies demonstrating AZD7798 confers rapid and sustained CCR9 cell depletion in blood with no major adverse tolerability or safety findings. Acknowledgement/FundingThe study was Sponsored and funded by AstraZeneca"

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

FIRST-TIME-IN-HUMAN VISUALISATION OF CCR9 EXPRESSION IN THE GUT BY POSITRON EMISSION TOMOGRAPHY (DDW 2024) - P1 | "To address this need we have developed a CCR9-specific PET tracer based on the small molecule CCR9 antagonist vercirnon. Conclusion :We have developed a CCR9-specific PET tracer which potentially enables repeatable quantification of CCR9 expression in the gut. Ongoing studies will assess the effects of AZD7798 on CCR9+ cell depletion/repletion in the gut providing critical data to support the clinical development programme."

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

First-time-in-human visualisation of CCR9 expression in the gut by positron emission tomography. (ECCO-IBD 2024) - P1 | "To address this need, we have developed a CCR9-specific PET tracer based on the small molecule CCR9 antagonist vercirnon. Conclusion We have developed a CCR9-specific PET tracer which potentially enables repeatable quantification of CCR9 expression in the gut. Ongoing studies will assess the effects of AZD7798 on CCR9+ cell depletion/repletion in the gut, providing critical data to support the clinical development programme."

Crohn's disease • 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 | Recruiting | Sponsor: AstraZeneca | Trial completion date: May 2024 ➔ Aug 2024 | Trial primary completion date: May 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • 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=144 | Recruiting | Sponsor: AstraZeneca | N=96 ➔ 144

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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting | Phase classification: P1b ➔ P1

Enrollment open • Phase classification • Crohn's disease • Gastroenterology • 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) - P1b | N=8 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial • 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=96 | Recruiting | Sponsor: AstraZeneca | N=64 ➔ 96 | Trial completion date: Nov 2023 ➔ May 2024 | Trial primary completion date: Nov 2023 ➔ May 2024

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