Ellipses Pharma Launches First Phase 1/2 Oncology Trial in the UAE with RET Inhibitor EP0031/A400
核心洞察
Ellipses Pharma (搜索) has initiated a Phase 1/2 clinical trial in the UAE, marking a significant advancement in the region's oncology research landscape.
The trial will evaluate EP0031/A400 (搜索), a next-generation selective RET (搜索) inhibitor, for treating RET-altered tumors, particularly in non-small cell lung cancer (搜索) and thyroid cancer (搜索).
EP0031/A400 (搜索) has received Orphan Drug and Fast Track designations from the FDA, expediting its development for serious conditions with unmet medical needs.
Ellipses Pharma (搜索) Limited has launched a Phase 1/2 oncology clinical trial in the United Arab Emirates (UAE), the first large-scale study of its kind in the region. The trial will assess the safety and efficacy of Ellipses' next-generation selective RET (搜索) inhibitor (SRI), EP0031/A400 (搜索), in patients with RET-altered tumors, most commonly found in non-small cell lung cancer (搜索) (NSCLC) and thyroid cancer (搜索).
The study, approved by UAE regulators and health authorities, will initially be conducted at Cleveland Clinic Abu Dhabi and Tawam Hospital, with a third center pending inclusion. Patient recruitment has already begun.
EP0031/A400: A Next-Generation RET Inhibitor
EP0031/A400 (搜索) is being developed as a potential treatment for RET (搜索)-driven cancers. Activating RET mutations and rearrangements are known oncogenic drivers in various tumor types, with a significant prevalence in NSCLC and thyroid cancer (搜索), accounting for approximately 2% of all solid tumors. The drug has already received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA), which are intended to accelerate the development and review of drugs for serious conditions with unmet medical needs.
Professor Tobias Arkenau, Global Head of Drug Development and Chief Medical Officer at Ellipses, stated, "The opening of the EP0031/A400 (搜索) trial in the UAE is a very exciting initiative...our belief has been reinforced that EP0031/A400 has the potential to be a transformational next generation RET (搜索) inhibitor - in particular for patients with RET-positive NSCLC and thyroid cancers, which remain a progressive and fatal condition for hundreds of thousands of patients worldwide."
Trial Design and Collaboration
The global Phase 1/2 trial of EP0031 (NCT05443126) is a collaborative effort between Ellipses and Kelun Biotech (搜索) (6990.HK), which is conducting parallel studies in China under the name A400 (NCT05265091). Ellipses holds exclusive rights to EP0031/A400 (搜索) in the US and Europe, while Kelun-Biotech retains certain rights in Greater China and other Asian countries. Previous modular Phase 1 studies have been conducted in the US, Europe, and China, with registrational Phase 2 trials ongoing in China, the US, Europe, and now the UAE.
Professor Sir Christopher Evans, OBE, Executive Chairman of Ellipses, emphasized the importance of the Abu Dhabi-based investors' support in enabling the trial and bringing innovative therapy to patients in the UAE. The trial also has support from M42, a tech-enabled healthcare company based in Abu Dhabi.
Addressing Unmet Needs in RET-Altered Cancers
While first-generation SRIs have shown efficacy in treating RET (搜索)-altered cancers, resistance mechanisms often develop, creating a need for next-generation inhibitors like EP0031/A400 (搜索). This new agent is designed to overcome acquired resistance and provide more durable responses for patients with RET-positive NSCLC and thyroid cancers.