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, and Qureight Ltd, a Core Imaging Laboratory developing deep-learning image analytics, today announced a collaboration for the integration of Qureight’s deep-learning platform into Rein’s planned 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).
Rein previously announced positive topline results from Cohort 2 (5 mg BID) of the Phase 1b clinical trial of LTI-03 in IPF, in which a positive trend was observed in seven out of eight biomarkers evaluated, with five biomarkers demonstrating dose-dependent effects and four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set.
The Phase 2 clinical trial of LTI-03 will continue to evaluate the safety, tolerability and efficacy of LTI-03 in IPF across multiple biomarkers and measure lung function and healthy tissue regeneration. In the trial, Qureight will provide full end-to-end imaging core lab services, including site qualification, data handling, quality control and deep-learning AI image analysis, across 50 sites globally. Qureight’s deep-learning platform will be used to analyze lung imaging data and identify correlations between any volumetric changes within the lungs of IPF patients and LTI-03’s efficacy. Qureight’s AI tools will measure the volume of fibrotic, vascular and airway lung compartments, allowing a more detailed examination of LTI-03’s ability to simultaneously modulate pro-fibrotic activity and to protect critical alveolar epithelial cells. Additionally, Qureight’s technology will improve the efficiency of the clinical trial workflow and significantly reduce the time required for image interpretation, in turn accelerating the trial.
“In our Phase 1b clinical trial of LTI-03, we emphasized the importance of biomarkers for measuring progress in patients with IPF treated with LTI-03 as well as for illustrating the dual mechanism of LTI-03 in the body,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. “We are taking the evaluation of biomarkers a step further with the application of cutting-edge deep-learning imaging technology and detailed AI-based data analysis by collaborating with Qureight on this Phase 2 trial. These tools will be critical in gaining a deeper understanding of the potential therapeutic effect of LTI-03.”
Dr. Muhunthan Thillai, Chief Executive Officer of Qureight, said, “We’re delighted that our core platform and AI technology will be supporting Rein Therapeutics in advancing its treatment, LTI-03, for patients with IPF. Our AI tools will provide precise, quantitative insights into how LTI-03 affects lung structure and function. This partnership represents another milestone in accelerating fibrotic lung disease treatment, which is so desperately needed for patients."
Rein plans to announce further details on the design of the Phase 2 trial of LTI-03 in IPF in the second quarter of this year.
About IPF
IPF is a chronic lung disease characterized by progressive tissue scarring that prevents proper lung function. It is a progressive, fatal, age-associated lung disease affecting approximately 100,000 people in the United States1. IPF typically presents in adults 65 or older and is usually fatal within two to five years after diagnosis2.
About LTI-03 and Caveolin-1 (Cav1)
LTI-03 is a seven amino acid peptide, the sequence of which is derived from the caveolin scaffolding domain (CSD), an important binding region of the Cav1 protein. Cav1 normally serves a critical function in the prevention of fibrosis by maintaining a balance between pathways that both initiate and arrest lung repair and cell movement. Through the CSD, caveolin interacts with a large number of signaling molecules, all of which possess a caveolin binding domain region. Cav1 expression is decreased in IPF lung tissues and has been demonstrated to decrease during the fibrotic phase of bleomycin, or BLM, lung injury in mice. Restoring the balance of important biological signals in the lung may not only slow lung function decline but could also restore healthy lung function through the protection of healthy epithelial cells.
About Qureight
Founded in 2018 and headquartered in Cambridge, UK, Qureight is a Core Imaging Laboratory, a rapidly-scaling techbio company deploying its technology on a global scale. The cloud-based, vendor-agnostic Core Imaging Platform is GDPR, HIPPA and NHS Digital compliant. The platform has ISO13485 and ISO27001 accreditation to interrogate clinical trial data. The team is led by co-founder & CEO Dr Muhunthan Thillai, a pulmonologist who trained in lung fibrosis.
About Rein Therapeutics
Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein’s lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. A Phase 2 clinical trial of LTI-03 for the treatment of idiopathic pulmonary fibrosis is anticipated to be initiated in the first half of this year. Rein’s second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and E.U. and Fast Track Designation in the U.S. For more information, please visit the company’s website at reintx.com, or follow them on LinkedIn and X.
References
1Pergolizzi, Jr., J., LeQuang, J., Varrassi, M., Breve, F., Magnusson, P., Varrassi, G., (2023). What Do We Need to Know About Rising Rates of Idiopathic Pulmonary Fibrosis? A Narrative Review and Update. Springer Nature, Published online 2023 Jan 24. Doi: 10.1007/s12325-022-02395-9.
2Nathan et al. "Long-term Course and Prognosis of Idiopathic Pulmonary Fibrosis in the New Millennium". Chest Journal Volume 140, ISSUE 1, P221-229, July 2011.