Laminar Pharmaceuticals Completes Recruitment for CLINGLIO Phase 2b/3 Trial

Laminar Pharmaceuticals S.A., a clinical-stage biotech company, has announced the successful recruitment of 140 adult patients for its CLINGLIO study. This pivotal phase 2b/3 trial is examining the efficacy of idroxioleic acid in combination with Standard of Care treatments for newly diagnosed glioblastoma patients. The multinational, randomized, placebo-controlled, double-blind trial aims to assess the added benefit of idroxioleic acid to standard treatments, which include tumor resection and chemoradiotherapy.

Idroxioleic acid, also known as LAM561 or 2-hydroxyoleic acid (2-OHOA), is a synthetic fatty acid administered orally. It represents a novel therapeutic approach for treating glioblastoma, a highly aggressive and fatal brain cancer. The trial is being conducted across 21 hospitals in Spain, Italy, France, and the United Kingdom and is funded by a European Commission Grant (H2020).

Adrian McNicholl, Chief of Clinical Operations at Laminar Pharmaceuticals, stated, "The completion of recruitment is a significant milestone that will soon allow us to evaluate the trial's results." An interim analysis, expected in July 2024, will provide an unblinded readout by the year's last quarter. Should idroxioleic acid show significant benefits in progression-free survival and overall survival, it could become the first new addition to the Standard of Care for glioblastoma patients since Temozolomide was approved in 2005. The results will be submitted for Conditional Marketing Authorization to the European Medicines Agency (EMA) in early 2025, with the trial continuing until a final analysis of survival in 2026.

Pablo Escribá, CEO of Laminar Pharmaceuticals, emphasized the importance of this milestone. "We are eager to potentially offer a new treatment for glioblastoma, addressing one of the most pressing unmet needs in oncology," he said. The CLINGLIO trial, initiated in December 2019, randomized patients in a 1:1 ratio to receive either idroxioleic acid or a placebo, alongside Standard of Care treatments. Treatment continues as long as the patient's tumor does not progress.

So far, idroxioleic acid has shown a favorable safety profile in both pre-clinical and clinical trials. An Independent Data Monitoring Committee (IDMC) has reviewed the available safety and efficacy data and recommended continuing the trial without modifications. The trial's promising preliminary results suggest that if substantial clinical benefits are demonstrated, it may be sufficient to request conditional marketing authorization in the EU later this year, with the potential for full marketing authorization in 2026.

Laminar Pharmaceuticals, established in 2006 and headquartered in Mallorca, Spain, focuses on the development of novel therapies for various pathologies, including cancer, through synthetic fatty acids. The company utilizes its proprietary Melitherapy (Membrane Lipid Therapy) technology to design and develop first-in-class health solutions. Laminar manages all stages of drug development, from molecular design to clinical trials, maintaining high standards and continual investment in research and development.

Glioblastoma remains one of the most common and deadly primary malignant brain tumors, accounting for nearly half of all gliomas and approximately a quarter of all primary malignant brain and CNS tumors. In Europe, over 25,000 new cases are diagnosed annually, with more than 100,000 cases worldwide each year. Despite optimal treatment, the median survival time for glioblastoma patients is about 14.5 months, with only 15% surviving two years post-diagnosis and a mere 4% reaching five years. Therefore, there is an urgent need for innovative and effective treatments to improve clinical outcomes for these patients.

Idroxioleic acid represents Laminar's most advanced research and development product. It works by modifying the plasma membrane composition in cancer cells, thus reducing the activity of signaling proteins that promote tumor growth. The drug has shown promising preliminary clinical activity in treating aggressive high-grade glioblastoma and is now in the final stages of its clinical development.