RNTX

RENEW Phase 2 trial evaluating the safety, tolerability, and efficacy of LTI-03 in idiopathic pulmonary fibrosis (IPF) initiated with topline interim data expected in the first half of 2026 Two abstracts accepted to the American Thoracic Society (ATS) 2025 International Conference Cash runway extended following previously announced warrant transactions and private placement AUSTIN, Texas, May 15, 2025 /PRNewswire/ -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the first quarter ended March 31, 2025 and provided a business update. "Rein has completed a multitude of key accomplishments since the beginning of the year, and we are particularly excited to have initiated the Phase 2 RENEW trial of LTI-03 in patients with IPF," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "We have taken several strategic steps to prepare for this trial. Our LTI-03 program continues to evolve as we entered into a collaboration with Qureight to bring cutting-edge technology to our imaging and data analysis and obtained patents covering our novel formulation and administration methods. We are committed to continuing this momentum of execution and we look forward to advancing the RENEW trial and sharing topline interim data, which is expected in the first half of next year." Recent Clinical and Corporate Highlights and Upcoming Milestones Clinical Updates In May 2025, the Company initiated the RENEW Phase 2 trial of LTI-03 in idiopathic pulmonary fibrosis (IPF), with screening and recruitment of patients underway. The RENEW trial is a multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF. The trial is designed to enroll approximately 120 patients randomized into two cohorts to receive either low dose (2.5 mg BID) or high dose (5 mg BID) of LTI-03 or placebo. Topline interim data from this trial is expected in the first half of 2026. In April 2025, Rein announced a collaboration with Qureight Ltd to integrate Qureight's deep-learning AI image analysis into the Phase 2 RENEW trial of LTI-03, to allow for a more detailed examination of LTI-03's potentia...

Rein advanced the clinical development of its lead asset, LTI-03, and aims to initiate a Phase 2 trial for the treatment of idiopathic pulmonary fibrosis (IPF) in the first half of 2025 Positive topline results from Cohort 2 (5 mg BID) of the Phase 1b clinical trial of LTI-03 in IPF patients demonstrated dose dependent effects in five biomarkers evaluated, with four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set AUSTIN, Texas, April 7, 2025 /PRNewswire/ -- Rein Therapeutics, Inc. (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided a business update. "We've made significant clinical progress during 2024, culminating in promising safety and positive topline data from our Phase 1b trial of LTI-03 in IPF patients, which demonstrated early signs of therapeutic effect. LTI-03 has shown potential to improve lung function and potentially reverse the course of IPF, with its dual mechanism of action on both epithelial cells and fibroblasts gaining increasing support within the medical community," said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. "With our recent rebranding and renewed mission to combat fibrosis, we are excited to advance our pipeline. We are planning to initiate a Phase 2 study for LTI-03 in IPF in the first half of this year, where we will continue to evaluate the safety, tolerability and efficacy of this promising asset." Recent Clinical and Corporate Highlights and Upcoming Milestones Clinical Updates In November 2024, Rein announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients diagnosed with IPF. Four biomarkers showed statistical significance in the combined Cohort 1 and Cohort 2 data set, and five demonstrated dose dependence, indicative of active pharmacodynamics. High dose LTI-03 continued to exhibit a favorable safety profile. A Phase 2 trial of LTI-03 for the treatment of IPF is anticipated to be initiated in the first half of this year, subject to funding. In October 2024, at the 22n...