Lipum AB (publ), a Swedish biopharmaceutical company focusing on innovative treatments for chronic inflammatory diseases, presented positive findings from its first-in-human clinical trial of SOL-116 at the American College of Rheumatology (ACR) Annual Meeting 2024.

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.

Contacts
Ola Sandborgh, CEO
ola.sandborgh@lipum.se
+46 72 218 80 21
Web: www.lipum.se

About Us
Lipum AB (publ) is a clinical stage biopharmaceutical company specialized in discovery and development of a novel treatment for chronic inflammatory diseases. The lead candidate SOL-116 is a humanized antibody designed to provide efficacious therapy by blocking a previously overlooked target molecule of the immune system (BSSL). SOL-116 is in clinical stage supported by solid data for rheumatoid arthritis. Lipum also explores other inflammatory diseases with a high unmet medical need. The company is based in Umeå, an excellent life science cluster in Sweden. Lipum’s unique approach has attracted international attention, including a major European Commission Horizon 2020 grant. The company's share (LIPUM) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission.

Attachments
Lipum Presents Promising Data on Novel Antibody SOL-116 at ACR 2024