Eli Lilly Licenses Clazakizumab from CSL in $100 Million Deal

CSL Limited has entered into an exclusive licensing agreement with Eli Lilly and Company which grants Lilly certain rights to develop and commercialize clazakizumab, an anti-interleukin-6 (IL-6) monoclonal antibody. Under the agreement's terms, CSL receives an upfront payment of $100 million and remains eligible for future clinical, regulatory, and commercial milestones, as well as royalties on global net sales.

The agreement effectively splits the development path of the monoclonal antibody based on specific therapeutic indications. CSL retains exclusive rights to develop and commercialize clazakizumab for the prevention of cardiovascular events in patients with end-stage kidney disease (ESKD). Lilly will explore development, global regulatory approval, and commercialization of clazakizumab in additional indications beyond ESKD-related cardiovascular risk.

CSL is maintaining its focus on the primary indication through the ongoing POSIBIL6ESKD Phase III clinical trial (NCT05485961), which is currently evaluating the safety and efficacy of the treatment in preventing cardiovascular events for patients with ESKD who are on dialysis. This targeted approach addresses a specific high-risk patient population.

Clazakizumab was originally developed by Vitaeris Inc. and joined CSL's pipeline after the company acquired Vitaeris in 2020. The monoclonal antibody targets IL-6, a cytokine involved in immune regulation, hematopoiesis, and vascular inflammation. Elevated IL-6 levels have been linked to chronic inflammation and a range of immuno-inflammatory and cardiovascular diseases. By inhibiting IL-6 from binding to its receptor, clazakizumab is designed to reduce inflammatory signaling associated with disease progression.

Supporting the Phase III program, earlier mid-stage data demonstrated significant anti-inflammatory effects in dialysis patients at elevated cardiovascular risk. In a Phase 2b dose-finding study, adults with cardiovascular disease and/or diabetes receiving maintenance dialysis and elevated high-sensitivity C-reactive protein were randomized to receive clazakizumab at doses of 2.5 mg, 5 mg, or 10 mg every four weeks, or placebo. The primary endpoint was change in hs-CRP at 12 weeks.

Clazakizumab reduced hs-CRP levels by 86%, 90%, and 92% in the 2.5 mg, 5 mg and 10 mg groups, respectively, compared with placebo, meeting the primary endpoint. Between 79% and 82% of treated patients achieved hs-CRP levels below 2 mg/L, versus none in the placebo arm. The therapy also reduced additional inflammatory and cardiovascular biomarkers, including fibrinogen, serum amyloid A, secretory phospholipase A2 and lipoprotein(a), while increasing serum albumin levels at 12 weeks.

The EVP and head of R&D at CSL commented in a press release, "This agreement marks a significant step forward in our mission to bring innovative therapies to patients worldwide. Clazakizumab is a promising therapeutic candidate with the potential to significantly impact the treatment landscape for various immuno-inflammatory and cardiovascular conditions. Lilly is another patient-focused organization, and we look forward to working with them to maximize the potential of this important medicine."

The transaction remains subject to customary closing conditions, including required regulatory clearances.