Bifogade filer
Lipum's ongoing clinical phase 1 study proceeds as planned
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Läkemedel & Handel |
Lipum AB (publ) announces that the clinical phase 1 study with the drug candidate SOL-116 is proceeding as planned. After a fourth dose escalation, a safety evaluation has now been conducted and as expected, data show that SOL-116 remains safe and well tolerated. The study is therefore continuing as planned with a higher dose level for the fifth group. SOL-116 is being developed for the treatment of chronic inflammatory diseases.
The study is designed as a double-blind, randomized and placebo controlled FIH (First In Human) study and includes up to six dose groups of healthy subjects. In addition, a group of patients diagnosed with rheumatoid arthritis will participate in the study.
"The study proceeds very well, and we are on schedule. We are also approaching the stage where a group of patients can be included, which provides the opportunity to study any differences between healthy subjects and patients with rheumatoid arthritis and provide guidance in the design of subsequent studies.", says Einar Pontén, CEO of Lipum.
The primary objective of the study is to establish safety and tolerability of SOL-116, and the secondary objective is to study its pharmacokinetics. The study is a dose escalation study, and each subject receives only one dose of SOL-116 (Single Ascending Dose, SAD). After safety evaluation of a whole group, the dose is gradually increased for each new group included in the study.