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), first patient dosed in March.
Phase 1 study SOL-116
Lipum has completed the first part of the clinical phase 1 study, where healthy volunteers received a single dose 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 placebo-controlled first in human study in three parts and includes in total 48 healthy subjects in five single-dose groups with dose escalation (SAD), one multiple-dose group (MD) and in addition to these, a group of eight patients with rheumatoid arthritis are included in the study during the spring of 2024.
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.
