Press release: Umeå, September 3, 2021. The dose-finding toxicology- and safety studies on Lipum’s candidate drug (SOL-116) have been completed according to plan and the final Clinical Trial Application (CTA)-enabling toxicology study has now started.
The non-clinical program for toxicology- and safety studies of Lipum’s candidate drug (SOL-116) is carried out in collaboration with the contract research organisation (CRO) Charles River Laboratories. Previous dose finding studies, which included various dose levels, were conducted in two different species with a treatment period of four weeks. The results and conclusions from these studies were satisfactory and a 13-weeks Good Laboratory Practice (GLP) compliant study has therefor commenced. GLP studies constitutes the last part of the pre-clinical program before a clinical trial application can be filed.
"We are very pleased with the progress both with regards to the results and the adherence to time plans for this mandatory work, which is required to reach our next milestone and start clinical studies.” - says Einar Pontén, CEO.
Lipum AB (publ) is a biopharmaceutical company specialized in discovery and development of a novel treatment for chronic inflammatory diseases. The lead candidate SOL-116 is a humanized antibody designed to provide efficacious therapy by blocking a previously overlooked target molecule of the immune system (BSSL). SOL-116 is in late preclinical stage supported by solid data for the rare disease juvenile idiopathic arthritis and rheumatoid arthritis. Lipum also explores other inflammatory diseases with a high unmet medical need. The company is based in Umeå, an excellent life science cluster in Sweden. Lipum’s unique approach has attracted international attention, including a major European Commission Horizon 2020 grant. The company's share (LIPUM) is traded on the Nasdaq First North Growth Market. Certified Adviser is G&W Fondkommission, email: firstname.lastname@example.org, phone: +46 8 503 000 50.