Backed by $70m in Series A funding, Elevara Medicines has launched to advance its CDK4/6 inhibitor, which belongs to a drug class that has traditionally been used in breast cancer, as an add-on rheumatoid arthritis (RA) therapy.
The UK-based biotech anticipates dosing the first participant with its lead asset ELV001, previously known as TCK-276, by the end of 2025 in a Phase II study, according to CEO Emma Tinsley. The study, dubbed START-SYNERGY, is expected to enrol 180 participants with inadequate response to methotrexate and TNF inhibitors, as per Tinsley.
The Phase II trial will aim to demonstrate an additive effect of ELV001 in patients with an inadequate response to standard of care (SoC). The primary endpoint to be tested is ACR20, said Tinsley. ACR20 denotes a 20% improvement in swollen and painful joints according to American College of Rheumatology (ACR) criteria.
Tinsley told Pharmaceutical Technology that Elevara plans to accelerate timelines with a seamless trial design, setting its sights on study completion within around 2.5 years. Elevara will aim to target a hard-to-treat population with ELV001, those with partial response to SoC, which is often methotrexate plus a biologic. Tinsley said this equates to roughly 50% of patients with RA.
Elevara has taken a unique approach in the rheumatoid arthritis space by looking to CDK4/6 inhibitors. Inhibiting CDK4/6 was observed to suppress the production of inflammatory markers in synovial fibroblasts and prevent the proliferation of these cells, thereby targeting the synovial sites without suppressing the immune system as a whole, said Tinsley. She explained that despite their potential in targeting underlying disease mechanisms in RA, use of CDK4/6 inhibitors has been avoided due to associated side effects – a problem which Elevara hopes to address with an improved therapeutic index of its candidate drug.
ELV001, initially developed by Teijin Pharma, was shown to be well tolerated in doses of up to 175 mg/day for seven days and no clinically meaningful safety signals were observed in patients with active RA in Phase Ib testing, per results published in Rheumatology.
Tinsley also alluded to the initiation of preclinical investigation in other disease areas, including women’s health and chronic inflammatory conditions, working back from the cellular mechanisms of action to find disease areas where the candidate may have potential.
