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 dosed all healthy volunteers as well as patients with rheumatoid arthritis in the phase 1 study of the drug candidate SOL-116. Interim results confirm an expected pharmacokinetic profile and a continued good safety profile, as well as strong interaction between SOL-116 and its target protein BSSL (Bile Salt-Stimulated Lipase).
The study is a double-blind, randomized, and placebo-controlled FIH (First In Human) study consisting of three parts. A total of 48 healthy volunteers participated in five single-dose escalation groups (SAD) and one group received multiple doses (MD). In addition, eight patients with rheumatoid arthritis were included in the study.
In summary, the results of the first part of the phase 1 study (SAD) show that SOL-116 is well tolerated with few and no serious side effects observed in the subjects at the different dose levels. No subject was found to have anti-drug antibodies (immunogenicity) after dosing. The results show an expected and preferred pharmacokinetic profile with SOL-116 being well absorbed in the body and having a half-life of 20 days. SOL-116 reduces the amount of the target protein BSSL in plasma to undetectable levels from day 3 after administration, which was maintained until day 90 post-dose. The results show that SOL-116 is a potent BSSL-binding antibody that can effectively eliminate freely circulating BSSL in humans after a single dose of SOL-116.
After the results from the phase 1 study have been evaluated, the next step in the clinical development awaits, which is a phase 2 study where we will study the efficacy of SOL-116 in patients with rheumatoid arthritis.
