Lipum today announced that results from the First-in-Human (FIH) Phase I trial of its drug candidate SOL-116 have been published in the peer-reviewed journal RMD Open. SOL-116 is a first-in-class humanised monoclonal antibody targeting bile salt-stimulated lipase (BSSL), a novel mechanism for rheumatoid arthritis (RA) and other chronic inflammatory diseases.

The randomised, double-blind, placebo-controlled trial (NCT05576012) evaluated subcutaneous SOL-116 in 56 participants - 48 healthy volunteers and 8 patients with mild RA. SOL-116 was safe and well tolerated across all dose levels, with mainly mild adverse events and a low immunogenicity profile. Exposure increased dose-proportionally with a long half-life supporting infrequent dosing, and free circulating BSSL was effectively and durably reduced, confirming target engagement.

"These are strong first-in-human results: a favourable safety and pharmacokinetic profile and clear confirmation that SOL-116 reaches its target. This is the foundation we wanted before testing efficacy in patients. We now look forward to our fully funded Phase IIa proof-of-concept study, now in start-up," says Peter Hovstadius, MD, PhD, Chief Medical Officer at Lipum.

Read more on Lipum’s website, where access to the publication is available.

Contacts

Ola Sandborgh, CEO

+46 72 218 80 21

Web: www.lipum.se

About Us

Lipum AB 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 phase with a successfully completed Phase 1 study. Together with strong preclinical data, we have a solid foundation for continued development in the treatment of 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.

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