Lipum Announces Peer-Reviewed Publication of Positive First-in-Human Phase I Results for SOL-116
Lipum Announces Peer-Reviewed Publication of Positive First-in-Human Phase I Results for SOL-116
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.