A PET study to assess brain and lung uptake of PIPE-791
Research type
Research Study
Full title
A Phase 1b, open-label study of PIPE-791 to determine brain and lung lysophosphatidic acid receptor 1 (LPA1) occupancy by [18F] PIPE-497 PET imaging in healthy volunteers, volunteers with progressive multiple sclerosis, and volunteers with idiopathic pulmonary fibrosis.
IRAS ID
1010395
Contact name
Nikki Nepomuceno
Contact email
Sponsor organisation
Contineum Therapeutics, Inc
Clinicaltrials.gov Identifier
Research summary
The study drug (PIPE-791) is an experimental new medicine for treating progressive multiple sclerosis (PrMS) and idiopathic pulmonary fibrosis (IPF). People with PrMS often have problems with thinking, learning and movement, due to damage to the myelin sheath, a layer that surrounds and protects nerves. People with IPF often have difficulty breathing, dry cough and experience shortness of breath, due to scarring on the lungs.
We hope that PIPE-791 will work by binding to sites in the brain and lungs called lysophosphatidic acid receptor 1 (LPA1) and blocking the activity of those sites to reduce damage to the nerves in patients with PrMS and reduce scarring on the lungs in patients with IPF.
We’ll test single doses of PIPE-791 to find out its side effects and blood levels, and to see if PIPE-791 enters the brain or lungs and binds to LPA1. To find out, we’ll use a PET (positron emission tomography) scan, which makes images of the brain or lungs.
This is a 3-part study in up to 28 participants aged 25–65. Eligible participants will take a single dose of PIPE-791 and have 3 PET scans of their brain or lungs. Participants who have a brain PET scan will also have a magnetic resonance imaging (MRI) scan at a separate screening visit, which uses a strong magnetic field to take pictures of the brain.
In Part A, up to 16 healthy men and women who can’t have children will take about 5 weeks to complete the study, during which they will stay on the ward for at least 3 nights in a row and make up to 3 outpatient visits.
Parts B and C will each have up to 6 patients with PrMS and IPF, respectively, who will take up to 6 weeks to complete the study, during which they will stay on the ward for up to 6 nights in a row and make up to 4 outpatient visits.
A pharmaceutical company, Contineum Therapeutics, Inc is funding the study.
The study will take place at 1 research centre and 1 imaging centre in London.
REC name
HSC REC A
REC reference
24/NI/0104
Date of REC Opinion
25 Oct 2024
REC opinion
Further Information Favourable Opinion