Lipum’s clinical development
Single ascending dose (SAD), 40 healthy volunteers (HV) have been included.
Multiple dose (MD), 8 healthy volunteers (HV) have been included.
Single dose (SD), 8 patients with rheumatoid arthritis (RA) have been included.
Phase 1 study SOL-116
Lipum has successfully completed its phase 1 clinical study of the drug candidate SOL-116, involving healthy volunteers and patients with rheumatoid arthritis (RA). The Clinical Study Report (CSR) was completed and published in April 2025. The study confirmed an expected pharmacokinetic profile, a continued favorable safety profile, and a strong interaction between SOL-116 and its target protein, bile salt-stimulated lipase (BSSL).
This double-blind, randomized, placebo-controlled First-in-Human (FIH) study was conducted in three parts. A total of 48 healthy subjects participated across five single ascending dose (SAD) cohorts and one multiple dose (MD) cohort. Additionally, eight patients with rheumatoid arthritis were included in the study.
The final results demonstrate that SOL-116 was well tolerated across all dose levels, with no serious adverse events deemed related to the investigational drug. There was anti-drug antibodies (ADA) detected in only one participant (RA cohort), and the patient reverted to ADA-negative at the subsequent measurement. The results also show dose-proportional increases in exposure and an average terminal half-life of about 16–21 days supporting a once-monthly dosing regimen. A target engagement was confirmed where exploratory results demonstrated reduced levels of BSSL in participants receiving SOL-116, suggesting direct on-target activity.
Results from this trial support the continued clinical development of SOL-116, including larger phase 2 trials in RA. Lipum aims to further explore efficacy, refine dosing strategies, and deepen understanding of the drug’s mechanism of action in patients with active, moderate to severe rheumatoid arthritis.
