MEDI0618 / AstraZeneca - LARVOL DELTA

AURORA: A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine (clinicaltrials.gov) - P2 | N=12 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=408 ➔ 12 | Trial completion date: Sep 2026 ➔ Sep 2025 | Trial primary completion date: Sep 2026 ➔ Sep 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Efficacy of MEDI0618, a pH-dependent monoclonal antibody targeting PAR2, in preclinical models of migraine. (PubMed, Brain) - "MEDI0618 was administered subcutaneously to C57BL6/J female mice prior to induction of migraine-like pain with (i) systemic nitroglycerin or compound 48/80 (mast cell degranulator); or (ii) with supradural compound 48/80 or an inflammatory mediator (IM) cocktail. Further, blockade of PAR2 with MEDI0618 was effective in all preclinical migraine models studied but not in a model of post-traumatic headache. MEDI0618 may represent a novel therapy for migraine prevention with activity against CGRP-dependent and independent attacks."

Journal • Preclinical • CNS Disorders • Migraine • Pain • Vascular Neurology • ST14

MEDI0618: Data from P2 AURORA trial (NCT06602479) for migraine in 2026 (AstraZeneca) - Q4 & FY2024 Results

P2 data • Migraine

MEDI0618: Data from P2 AURORA trial (NCT06602479) for migraine post 2025 (AstraZeneca) - Q3 2024 Results

P2 data • Migraine

AURORA: A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine (clinicaltrials.gov) - P2 | N=408 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine • Pain

AURORA: A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine (clinicaltrials.gov) - P2 | N=408 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • CNS Disorders • Migraine • Pain

Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed | N=24 ➔ 36

Enrollment change • Trial completion • Pain

Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=48 ➔ 24

Enrollment change • Enrollment closed • Pain

Preclinical Assessment of MEDI0618, A Novel PAR2 Monoclonal Antibody for Treatment of CGRP-dependent and CGRP-independent Migraine-like Pain (AHS 2023) - No abstract available

Preclinical • CNS Disorders • Migraine • Pain

Preclinical Assessment of MEDI0618, A Novel PAR2 Monoclonal Antibody for Treatment of CGRP-dependent and CGRP-independent Migraine-like Pain (AHS 2023) - No abstract available

Preclinical • CNS Disorders • Migraine • Pain

Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: AstraZeneca

New P1 trial • Pain

A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Pain • CRP

A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers (clinicaltrials.gov) - P1; N=64; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Pain • CRP

The development of proteinase-activated receptor-2 modulators and the challenges involved. (PubMed, Biochem Soc Trans) - P1 | "One company has taken the first PAR2 antibody (MEDI0618) into phase I clinical trial (NCT04198558). While this first-in-human trial is at the early stages of the assessment of safety, other research into the structural characterisation of PAR2 is still ongoing in an attempt to identify new ways to target receptor activity. This review will focus on the development of novel PAR2 modulators developed to date, with an emphasis placed upon the advances made in the pharmacological targeting of PAR2 activity as a strategy to limit chronic inflammatory disease."

Journal • Immunology • Inflammation

A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: AstraZeneca; Trial completion date: Jun 2021 ➔ Nov 2021; Trial primary completion date: Jun 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Pain • CRP