US-based biopharmaceutical company Rein Therapeutics has dosed the first subject in a Phase II trial of LTI-03, its lead asset for treating idiopathic pulmonary fibrosis (IPF).
The double-blind, placebo-controlled RENEW trial is set to assess the tolerability, efficacy and safety of LTI-03.
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It will take place across up to 50 global sites and enrol around 120 subjects who have been diagnosed with IPF within five years of screening.
Rein is partnering with clinical research service and healthcare intelligence provider IQVIA for the enrolment process.
The study’s primary goal is to measure the incidence of treatment-emergent adverse events over the first 24 weeks.
Its key secondary endpoint is LTI-03’s efficacy, which will be measured through methods such as forced vital capacity, percent-predicted forced vital capacity (FVC), and high-resolution computer tomography.
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By GlobalDataTo measure the treatment’s efficacy, Rein is working in partnership with UK-based core imaging laboratory Qureight.
Subjects in the trial will self-administer either the therapy or placebo using an inhaler.
They will go through regular lung function tests and specialised lung scans while blood samples will be gathered at every visit to measure the disease biomarkers.
Topline interim data from the trial is anticipated in the first half of next year.
Rein Therapeutics president and CEO Brian Windsor said: “We are pleased to have dosed the first patient in our RENEW Phase II trial of LTI-03 following initiation of the trial.
“We are encouraged by the strong body of evidence supporting LTI-03 as a potentially innovative treatment for patients with IPF whose needs are unmet by the current standard of care (SoC).”
Comprising a multi-pathway, Caveolin-1-related peptide that is inhaled into the lungs, LTI-03 has received orphan drug designation by the US Food and Drug Administration.
The drug is designed to protect and restore the function of the oxygen uptake cells and control lung fibrosis, potentially improving lung scarring.
