Clinical Trials: Ellipse Launches Program in the Middle East
Ellipses Pharma Limited, a global drug development company focused on advancing cancer treatments, has launched its first large-scale Phase 1/2 oncology clinical trial in the United Arab Emirates (UAE). This significant milestone in the region’s healthcare sector highlights Ellipses Pharma’s commitment to innovative cancer therapies and reinforces the UAE’s growing role in global medical research.
The groundbreaking Phase 1/2 clinical trial, approved by UAE regulators and health authorities, is the first of its kind in the country. It will take place at two prestigious healthcare centers in Abu Dhabi: the Cleveland Clinic and Tawam Hospital. Patient recruitment for the trial has already begun, with a third study center under consideration. This trial focuses on EP0031/A400, a next-generation selective RET inhibitor (SRI) designed to treat RET-altered tumors, commonly found in non-small cell lung cancer (NSCLC) and thyroid cancer. EP0031/A400 has shown promise as a potential therapy for patients with these mutations, offering hope for improved treatment options.
Professor Sir Christopher Evans, OBE, Executive Chairman of Ellipses Pharma, expressed excitement about the initiative and acknowledged the importance of collaboration with investors in Abu Dhabi who supported the company from the beginning. “This tremendous commitment has brought us to a point where we can provide innovative therapies for patients in the UAE and encourage healthcare professionals to collaborate on meaningful research,” he said. “This trial is just the beginning of many more in the region.”
Ellipses Pharma is partnering with M42, an Abu Dhabi-based tech-enabled company, to support the clinical trial. Sir Christopher Evans also serves on the advisory board of M42, which has played a vital role in advancing Ellipses’ efforts in the UAE. The company’s collaboration with the Emirates Drug Establishment further strengthens its presence in the region.
EP0031/A400 has gained significant attention from regulatory authorities. In November 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to EP0031/A400. In March 2024, it also received Fast Track Designation, aimed at expediting the development and review of drugs designed to treat serious or life-threatening conditions with unmet medical needs. These recognitions highlight the potential of EP0031/A400 to address pressing cancer treatment needs.
Professor Tobias Arkenau, Chief Medical Officer of Ellipses Pharma, emphasized the transformative potential of EP0031/A400 in treating RET-positive cancers. “Our belief in the transformative potential of EP0031/A400 has only been reinforced through clinical trials to date. It holds great promise for treating NSCLC and thyroid cancers, conditions that continue to be progressive and fatal for hundreds of thousands of patients worldwide,” he said.
EP0031/A400 is being developed in a joint clinical trial with Kelun Biotech, a Chinese pharmaceutical company. This trial is already underway in the U.S., Europe, China, and the UAE. Kelun Biotech has granted Ellipses an exclusive license to EP0031/A400 in certain regions, including the U.S. and Europe, while retaining rights in Greater China and other Asian countries.
RET-altered malignancies, particularly in non-small cell lung cancer and thyroid cancer, are caused by mutations or rearrangements in the RET gene. These genetic alterations account for approximately 2% of all solid tumors. Despite the development of first-generation SRIs, there remains an unmet need for next-generation therapies that can overcome acquired resistance mechanisms to these drugs. EP0031/A400 is expected to address this gap and provide an effective solution for patients with RET-altered cancers.
Ellipses Pharma is committed to accelerating the development of innovative cancer treatments. Using an efficient and de-risked drug development model, the company aims to minimize the time it takes to bring lead products to clinical trials and ultimately to patients in need. With the launch of this clinical trial in the UAE, Ellipses Pharma is poised to make a significant impact on cancer care in the region and beyond, providing hope for patients with RET-altered cancers and advancing the field of oncology.
