U.K. medtech Brainomix has entered into partnership with South Korean Bridge Biotherapeutics Inc. to deploy artificial intelligence in an early-stage trial of a novel autotaxin inhibitor for idiopathic pulmonary fibrosis (IPF).
Brainomix’s automated e-ILD software will be used for quantitative analysis of imaging data in the Phase II study, which examines the safety, tolerability and efficacy of the investigational therapy BBT-877 for the progressive and irreversible lung disease, for which there is currently no cure.
The companies hope to show how patented, AI-powered imaging biomarkers—whose changes can be tracked over time—can offer new endpoints for future IPF trials.
Current IPF trials often depend on serial measurements of forced vital capacity that can vary in patients on a day-to-day basis. Automated AI-powered quantitative imaging offers the potential to improve identification of positive treatment responses and speed new treatments into clinical practice.
“AI-powered imaging is becoming an increasingly critical component of studies in IPF and more broadly non-IPF interstitial lung diseases, where it has the potential to improve trial insights, and to complement existing trial methodology and endpoints,” said Peter George, respiratory medical director at Brainomix and clinical lead of the interstitial lung disease unit at the Royal Brompton Hospital, London, in a press statement.
Brainomix’s e-ILD technology has been developed to process high-resolution chest computed tomography data in patients with IPF and other conditions that cause progressive pulmonary fibrosis.
BTT-877 is an orally available, small-molecule inhibitor that suppresses inflammation and sclerosis by reducing the production of the lipid-signaling molecule lysophosphatidic acid by inhibiting the extracellular enzyme autotaxin.
The Phase II, randomized, double-blind, placebo-controlled trial will examine the impact of 200 mg twice daily BBT-877 , with or without the anti-fibrotic therapies pirfenidone or nintedanib, in patients with IPF for 24 weeks plus four weeks of follow up.
Bridge Bio announced last month that it had been given authorization by the U.S. Food and Drug Administration to proceed with the trial, with recruitment planned at 120 patients at 50 clinical sites in North America, Asia and Europe.
In July 2019, the company inked a deal with Boehringer Ingelheim for BBT-877 that included upfront and near-term payments of €45 million. But by November 2020, Boehringer had returned the investigational drug to Bridge Bio and there were questions over its continued development.
Brainomix, which first launched as a spin off from the University of Oxford in 2010, has already created AI-powered imaging biomarkers for stroke, interpreting brain scans and helping guide treatment and transfer options for patients.
The company announced this month that it had been awarded a national tender to deploy the software platform across all stroke centers in Hungary, following its installation at 10 centers around the city of Pécs.
