Ellipses Pharma has launched its first large-scale Phase 1/2 oncology clinical trial in the United Arab Emirates (UAE) for its selective RET inhibitor (SRI), EP0031/A400. This trial, focusing on RET-altered tumors prevalent in non-small cell lung cancer and thyroid cancer, is supported by Abu Dhabi investors and will initially be conducted at the Cleveland Clinic and Tawam Hospital in Abu Dhabi. The trial initiation follows the FDA’s granting of Orphan Drug and Fast Track Designations to EP0031/A400, highlighting its potential to address unmet medical needs.
This trial signifies a major advancement for cancer treatment accessibility in the UAE. It offers UAE patients access to a potentially groundbreaking therapy while fostering collaboration and research sharing among healthcare professionals in the region. The trial’s success could pave the way for more international clinical research collaborations and attract further investment in the UAE’s healthcare sector. This strengthens the UAE’s position as a hub for medical innovation and potentially improves healthcare outcomes for the regional population.
EP0031/A400 is being jointly developed by Ellipses globally and Kelun Biotech in China. The drug has already undergone Phase 1 studies in the US, Europe, and China, and registrational Phase 2 trials are now underway in those regions as well as the UAE. Ellipses holds exclusive licensing rights for EP0031/A400 in the US and Europe, while Kelun-Biotech retains rights in Greater China and certain Asian countries. Regulatory approvals for the drug have been secured in both the US and China. RET alterations are significant drivers in various cancers, especially non-small cell lung and thyroid cancer. Next-generation SRIs like EP0031/A400 are crucial in addressing acquired resistance to first-generation treatments, which underscores the trial’s potential impact.
This UAE trial initiation marks a critical step in the development of EP0031/A400. Positive results could lead to accelerated regulatory approvals and broader market access, solidifying Ellipses’ position in the oncology field. It also sets a precedent for international collaboration in drug development, potentially expediting the delivery of innovative cancer treatments to patients globally. The trial’s outcome will be crucial in shaping the future of RET-targeted therapies and the landscape of cancer care.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
