Participants sought for global clinical trial testing inhaled IPF therapy
Main goal of study, now open at all sites, is to evaluate treatment's safety
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An international clinical trial testing LTI-03, Rein Therapeutics’ inhaled treatment candidate for idiopathic pulmonary fibrosis (IPF), is now recruiting participants at sites in five countries.
The Phase 2 trial, dubbed RENEW (NCT06968845), aims to enroll approximately 120 people with IPF, ages 40 and older. Eligible participants will have been diagnosed within the last five years and, for those on IPF treatments, must be on a stable regimen, in addition to meeting certain criteria related to lung function.
During the study, participants will be randomly assigned to receive one of two doses of LTI-03 or a placebo, with the main goal of evaluating safety outcomes after about six months.
The study had previously been enrolling patients at sites in the U.S., the U.K., Poland, and Australia. Rein has now announced that the trial is also recruiting participants at sites in Germany — meaning the study is now up and running in all nations where it is planned to take place.
“Opening all five countries is an important operational milestone for our RENEW program,” Brian Windsor, PhD, Rein’s CEO, said in a company press release, which noted that early data is expected later this year.
“Enrollment continues to progress well across our active sites, and expanding into Germany, one of the leading centers for pulmonary fibrosis research in Europe, gives more patients the opportunity to participate,” Windsor said.
RENEW initially began recruiting patients in the spring of last year. The trial was temporarily put on hold by the U.S. Food and Drug Administration, but resumed a few months ago after Rein dealt with concerns raised by the regulatory agency, according to the company. Those concerns were not disclosed by the developer, with Rein merely stating that they had been addressed.
Top-line trial results expected later this year
According to the company, the trial is now on track to have results later this year.
“We remain focused on executing the trial, generating high-quality clinical data, and reporting initial topline data in [the second half of] 2026,” Windsor said.
IPF is marked by fibrosis, or scarring, in the lungs. LTI-03 contains a portion of a naturally occurring protein called caveolin-1 (Cav1) that can regulate fibrosis and inflammation.
The therapy has shown promise in both preclinical tests and an earlier clinical trial. In that Phase 1b study (NCT05954988), its use was shown to reduce fibrosis markers in people with newly-diagnosed IPF.
As a potential IPF treatment, LTI-03 has been granted orphan drug status by regulators in the U.S. and the European Union. This designation offers economic incentives to companies that are investing in the development of treatments for rare diseases.
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