Lipum announces that the first patient with rheumatoid arthritis (RA) has been enrolled and dosed with SOL-116 or placebo in the ongoing phase I clinical study in the Netherlands.
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 evaluating safety, pharmacokinetics and exploratory endpoints of SOL-116 in three parts: a single dose escalation part (SAD) with 40 healthy subjects divided in five groups, one multiple-dose group in eight healthy subjects and a single dose group of eight patients with rheumatoid arthritis (RA). The first part is completed, the second and third parts are ongoing.
Lipum recently reported positive interim results from the first part of the phase 1 study (SAD) showing that SOL-116 was well tolerated with few and no serious side effects observed in the subjects at 5 different dose levels. The results showed an expected and preferred pharmacokinetic profile with SOL-116 being well absorbed in the body and having a half-life of 20 days. It was also shown that SOL-116 in healthy subjects reduced 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.
”This is the first time a patient is included and dosed in the phase I study with SOL-116. We continue to deliver according to plan and are now one step closer to the next phase of clinical development" says Lipum's CEO Ola Sandborgh.