Rein Therapeutics begins dosing in Phase 2 trial of LTI-03 for IPF

Rein Therapeutics (Rein), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the first patient has been dosed in the RENEW phase 2 trial of its lead asset, LTI-03, a novel, multi-pathway, Caveolin-1-related peptide for the treatment of idiopathic pulmonary fibrosis (IPF).

"We are pleased to have dosed the first patient in our RENEW phase 2 trial of LTI-03 following initiation of the trial. We are profoundly focused on our mission to rein in fibrosis and look forward to continuing our momentum in the clinic.

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). I am grateful to our team at Rein, the patients, investigators, and staff participating in our trial for the efficient progress that we are making."

• Brian Windsor, Ph.D., president and chief executive officer of Rein Therapeutics.

About the RENEW Phase 2 Trial

The RENEW trial is a phase 2 multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF.

Rein is collaborating with IQVIA, a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries, on enrollment for the trial.

RENEW is designed to enroll approximately 120 patients diagnosed with IPF within 5 years of screening, who may be receiving SoC antifibrotic therapy, across up to 50 sites globally.

Primary and Secondary Endpoints

• Primary Endpoint: The incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24.
• Key Secondary Endpoint: Efficacy of LTI-03 measured through:
  • Forced Vital Capacity (FVC),
  • Percent Predicted FVC (ppFVC),
  • High-Resolution Computer Tomography (HRCT),
    in collaboration with Qureight Ltd.

Data Readout

Topline interim data from RENEW is expected in the first half of 2026.

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