Ellipses Pharma Limited („Ellipses“), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today the U.S. Food and Drug Administration (FDA) has confirmed the company’s next generation selective RET inhibitor (SRI), EP0031/A400, is clear to progress into Phase 2 clinical development.
EP0031 is being developed jointly by Ellipses in a global clinical phase 1/2 trial under the name EP0031 (NCT05443126) and Sichuan-Kelun Biotech in China under the names KL590586/A400 (NCT05265091). Modular Phase 1 studies have been conducted in the US, Europe and China and a registrational Phase 2 trial in China is ongoing.
Activating RET mutations and rearrangements have been identified as actionable drivers of oncogenesis in numerous tumour types and are most prevalent in non-small cell lung and thyroid cancer. It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours. After the successful development of first generation SRIs and an increasing understanding of escape mechanisms to these agents, there is an unmet need to develop new treatments that can address acquired resistance, including the development of next-generation SRIs.
