Lipum AB (publ) announces that the first part of the clinical phase 1 study, where healthy subjects received a single dose of the drug candidate SOL-116, has been completed with positive results. These confirm an expected pharmacokinetic profile, consistently good safety profile and that SOL-116 interacts with its target protein BSSL (bile salt-stimulated lipase).
The drug candidate SOL-116 is a humanized antibody that shall provide safer and more effective treatment of inflammatory diseases by blocking a previously overlooked target protein (BSSL) in the immune system.
The study is a double-blind, randomized and 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) and one multiple-dose group (MD). In addition to these, a group of eight patients with rheumatoid arthritis will be included in the study during the spring.
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 suggest 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.
The multiple-dose part of the study (MD) commenced in September and all healthy subjects have received their planned four doses of SOL-116 and are now being followed-up.
The phase 1 study is conducted in the Netherlands.
"It is exciting to see the positive interim results from the phase 1 study. This is a very important milestone for Lipum. Data generated on safety, pharmacokinetics, and SOL-116's interaction with the target protein BSSL confirm our expectations and provide important knowledge for the design of a phase 2 program. We really look forward to the next steps in the clinical development of SOL-116", says Ola Sandborgh, CEO of Lipum.