Unknown Lungs & Breathing NIHR-supported project Cancer

A Phase 1/2a Study Evaluating the Effects of ARO-MMP7 Inhalation Solution in Healthy Subjects and Patients with Idiopathic Pulmonary Fibrosis (ARROWHEAD)

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust Cambridge Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Ongoing

In plain English

AI plain-English summary

A new inhaled drug, ARO-MMP7, is being tested in healthy volunteers and people with idiopathic pulmonary fibrosis (IPF) to see if it is safe and can slow the scarring that stiffens the lungs. IPF is a progressive, fatal lung disease with no cure. The few available treatments only modestly slow its advance. The drug works by silencing the gene for MMP7, a protein found at abnormally high levels in the lungs of IPF patients and linked to tissue scarring. This trial is the first step in humans, starting with healthy volunteers to establish safety before moving to patients whose lungs are already damaged. If ARO-MMP7 proves safe and lowers MMP7 levels as intended, it could become a new treatment that directly targets a driver of fibrosis. That would give patients a therapy aimed at the underlying disease process rather than just managing symptoms. The trial is split geographically: healthy volunteers are enrolled in New Zealand, while the patient portion—including UK sites—takes place in Europe.

View original technical description
This is a Phase 1/2a, randomized, double-blind, placebo-controlled study in NHVs and patients with IPF. ARO-MMP7 is intended for use in patients with IPF. However, because these patients may have baseline decreased lung function and are frequently on multiple concomitant medications, this study will first evaluate dose levels in an NHV population to generate a baseline understanding of safety in a population with normal airway physiology and limited concomitant medication use prior to evaluating dose levels in patients with IPF. Additionally, NHV cohorts will generate an initial understanding of dose-response, using MMP7 protein concentration as a biomarker of PD effect. For all cohorts, participants who have signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form and met all the protocol eligibility criteria during Screening will be randomized to receive ARO-MMP7 or placebo.The NHV population (different cohorts) described in the Protocol will take part in Countries out of Europe (New Zealand) and just the cohorts referring to patients with IPF, described in the Protocol, will take part in the European portion of the trial including UK.

Researchers

Helen Parfrey (Principal Investigator)

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