Rein Therapeutics has surpassed 25% enrollment in its global Phase 2 RENEW trial of LTI-03 for idiopathic pulmonary fibrosis, with enrollment running ahead of schedule and interim clinical data still expected during the second half of 2026 as the company simultaneously reduces R&D and administrative spending.
RENEW is expected to enroll approximately 120 patients across the United States, United Kingdom, Australia, Germany and Poland. All clinical trial sites are now operational, and Rein said the pace of recruitment has put enrollment ahead of its planned schedule.
The randomized, placebo-controlled Phase 2 study is evaluating inhaled LTI-03, with change from baseline in forced vital capacity serving as its primary efficacy endpoint. Forced vital capacity is a commonly used measure of lung function in IPF studies.
LTI-03 is a synthetic peptide designed to inhibit multiple profibrotic proteins while protecting important progenitor cells in the lungs. The candidate mimics Caveolin-1, a regulator of several proteins involved in fibrosis-related pathways.
Rein believes the mechanism could differentiate LTI-03 by combining anti-fibrotic activity with potentially regenerative effects rather than focusing only on slowing the progression of fibrosis. Management has also highlighted what it views as a favorable safety and tolerability profile.
Additional support for the program came from a peer-reviewed publication in Nature Communications in July. Results from a first-in-human clinical study showed that LTI-03 was well tolerated and produced significant reductions in multiple markers associated with lung scarring.
Rein has strengthened its balance sheet ahead of the interim data catalyst. The company completed an oversubscribed $57.5 million underwritten public offering supported by new and existing healthcare-focused investors, including the full exercise of the underwriters’ overallotment option.
The company expects the financing to fully fund the Phase 2 RENEW trial and support operations into the first quarter of 2028. Rein held $43.6 million of cash, cash equivalents and marketable securities at June 30.
At the same time, quarterly operating expenses decreased across both major spending categories. R&D expenses declined to $3.6 million from $4.3 million a year earlier, primarily because direct research and development services costs decreased by approximately $700,000.
G&A expenses declined to $2.4 million from $2.6 million. Rein attributed the decrease primarily to lower employee-related expenses due to reduced stock-based compensation, along with lower facilities and other expenses.
Net loss narrowed to $6.4 million from $6.8 million in the prior-year quarter.
The combination of faster-than-planned RENEW enrollment, reduced quarterly expenses and the recent financing puts the upcoming interim data readout at the center of Rein’s near-term development strategy.
KEY QUOTES:
“We ended the second quarter with momentum as we made significant progress in our Phase 2 RENEW trial evaluating LTI-03 in patients with IPF and simultaneously bolstered our balance sheet supporting our work through key clinical milestones.”
“With all clinical trial sites up and running, we are encouraged by the rapid pace of enrollment we are seeing as we work to efficiently generate high-quality clinical data supporting LTI-03. We believe LTI-03 has the potential to be a differentiated multi-pathway treatment for patients with IPF and deliver both anti-fibrotic and potentially regenerative effects alongside a favorable safety and tolerability profile. With a strengthened balance sheet and enrollment ongoing in the trial, we believe we are well positioned to achieve our near-term clinical milestones, including reporting interim data in the second half of this year.”
Dr. Brian Windsor, President and CEO of Rein Therapeutics
