Ellipses’ next generation selective RET inhibitor EP0031/A400 cleared to start phase 2
May 1, 2024 – Biotechnology, Clinical Trials, Drug Discovery – Ellipses Pharma, next generation selective RET inhibitor
Drug has successfully completed US Food and Drug Administration (FDA)’s End of Phase 1 data review
1 May 2024 — London, UK — Ellipses Pharma, a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today the US 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/A400 is a potential treatment of RET-altered tumours and clinical data in studies to date has shown promising efficacy in patients with NSCLC, thyroid and other solid tumours. Durable responses have been seen in patients who were naive to, or who had been pre-treated with, 1st generation SRIs including in patients with brain metastases. The latest clinical data from the Ellipses phase 1 study will be presented at ASCO in Chicago, US, on 3 June 2024.
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.
The FDA granted Orphan Drug Designation to EP0031/A400 in November 2023 and in March of this year granted it Fast Track Designation, which facilitates the expedited development and review of new drugs intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Professor Sir Christopher Evans, chairman, Ellipses, said: “We are greatly encouraged with the progress to date of EP0031/A400 and look forward to rapidly generating phase 2 data, which will be another key step towards bringing this treatment to patients.”
Dr Rajan Jethwa, CEO, Ellipses, commented: “We are excited to announce another important clinical milestone as we continue to drive the development of EP0031 towards an NDA as a potential next-generation treatment for people living with RET-altered NSCLC and other cancers.”
Professor Tobias Arkenau, global head of Drug Development and chief medical officer, Ellipses commented: “At every stage our belief has been reinforced that EP0031/A400 can be a transformational treatment for patients with RET fusion-positive NSCLC, which remains a progressive and fatal condition for hundreds of thousands of patients worldwide, despite available treatment options.”
About Ellipses Pharma
Ellipses is a global drug development company based in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection with an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients. Visit: ellipses.life.
About Kelun-Biotech
Kelun-Biotech is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialisation and global collaboration of innovative drugs. The company focuses on major disease areas such as solid tumours, autoimmune, inflammatory and metabolic diseases. At present, the company has 33 on-going innovative projects for medical needs in selected major disease areas such as solid tumours, autoimmune, inflammatory and metabolic diseases, including 14 projects in the clinical stage and multiple global trials conducted in several regions such as China, Europe, and the US. For more information, please visit kelun-biotech.com/.
