SOL-116, a pioneering humanized monoclonal antibody developed by Lipum, specifically targets Bile Salt-Stimulated Lipase (BSSL), a protein linked to chronic inflammation in rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), and psoriatic arthritis (PsA). BSSL seems to play a critical role in disease progression by promoting inflammatory cell recruitment and migration. This trial, sponsored by Lipum, reports the safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple doses (MD) of SOL-116 in healthy subjects.

In the double-blind, placebo-controlled trial, SOL-116 demonstrated excellent tolerability across all dose levels, with no serious adverse events in five single ascending dose cohorts and one multiple dose cohort. Pharmacokinetics were predictable, with a mean half-life of approximately 20 days and no anti-drug antibodies (ADAs) detected, supporting the antibody’s long-term potential. Additionally, SOL-116 effectively eliminated circulating BSSL from Day 4 through Day 90 in healthy subjects, reinforcing its potential to modulate inflammatory responses over extended periods.

“We are encouraged by the favorable safety and pharmacokinetic profile of SOL-116, which provides strong support for its continued clinical development in rheumatoid arthritis,” says Dr. Peter Hovstadius, MD, PhD, Chief Medical Officer of Lipum AB.

Data from this trial represents a key step in advancing SOL-116 through clinical development. The trial also includes an ongoing cohort of rheumatoid arthritis (RA) patients, with final results for the entire study expected in Q1 2025.

“This novel approach could meet an unmet need in chronic inflammatory diseases by offering a targeted mechanism to reduce disease activity with minimal side effects” says Lipum’s CEO, Ola Sandborgh.

Further trials are planned to explore SOL-116’s efficacy in RA and other inflammatory diseases.