Rein Therapeutics has initiated the randomised RENEW Phase II trial of its Caveolin-1-related peptide, LTI-03, targeting idiopathic pulmonary fibrosis (IPF), with subject screening and recruitment now underway.
The double-blind, placebo-controlled, multi-centre trial is designed to assess the tolerability, efficacy and safety of LTI-03 in IPF patients.
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Additionally, it will evaluate the inhaled dry powder LTI-03 activity across various biomarkers and measure lung function, and the potential for regeneration of healthy tissue.
It aims to enrol nearly 120 subjects who have been diagnosed with this condition within five years of screening.
These subjects may also be receiving standard-of-care antifibrotic treatment. The study will span up to 50 sites worldwide, including Germany, the US, Austria, Poland, and the UK.
Rein noted that subjects in the trial will be randomised into two blinded placebo-controlled cohorts.
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By GlobalDataIn the low dose cohort, subjects will be given 2.5mg of either the therapy or placebo, administered two-times daily for a total daily dose of 5mg. The high-dose cohort will be given 5mg twice a day, totalling 10mg per day.
Rein Therapeutics president and CEO Brian Windsor said: “Following productive FDA interactions and positive topline results from the Phase Ib trial, we have designed our RENEW trial to test the promise of our dual mechanism approach to targeting alveolar epithelial cell survival and the inhibition of profibrotic signalling in this patient population.”
The incidence of treatment-emergent adverse events from day one through week 24 is the primary endpoint of the trial.
The key secondary endpoint is the efficacy of the therapy, which will be measured via percent predicted FVC, forced vital capacity and computer tomography, in partnership with Qureight.
Subjects will undergo a screening period for 28 days before randomisation and a 24-week treatment duration, with a follow-up period of four weeks.
Previously, the company reported positive top-line outcomes from cohort two of the Phase Ib trial of the therapy in IPF, where a positive trend was identified in seven out of eight biomarkers assessed.
Five biomarkers showed dose-dependent effects, and four met statistical significance when combining data from cohorts one and two.
