Lipum AB (publ) announces that the Phase 1 clinical study with the drug candidate SOL-116 has started and is progressing according to plan. To date, a first dose group of eight healthy volunteers have received a dose, with two of the volunteers receiving placebo.
The drug candidate SOL-116 is a fully humanised antibody that, through a unique mechanism of action, is intended to address a major unmet medical need in the treatment of certain chronic inflammatory diseases.
The Phase 1 study, now underway, is designed as a double-blind, randomised, placebo-controlled study and includes up to six groups of healthy volunteers. In addition, a group of eight patients with rheumatoid arthritis will also participate in the study.
The primary objective of the study is to determine the safety and tolerability of SOL-116, with the secondary objective to study its pharmacokinetics when administered to humans. The study is a dose-escalation study, which means that subjects will be divided into groups of eight. After safety evaluation, the dose is gradually increased for each group included. This means that each subject receives only one dose (Single Ascending Dose, SAD). In addition, there is an exploratory expectation that the study will also provide an opportunity to study possible differences between healthy volunteers and patients with rheumatoid arthritis, which could, among other things, provide guidance for the design of subsequent studies.
The study is being conducted in the Netherlands and is expected to be finally reported in the last quarter of 2023.
"We have now entered the clinical phase, and this is of course an extremely important milestone. As a biopharmaceutical company with a unique approach, we see great opportunities to treat multiple inflammatory diseases with SOL-116. Work to evaluate these opportunities and the planning of the next clinical study is already in progress. I am very pleased to have a competent team with extensive experience in drug development", says Einar Pontén, CEO of Lipum.