Stockholm, Sweden, April 14, 2025. Flerie AB announces that its portfolio company Lipum has presented final results from a Phase I trial evaluating SOL-116 in healthy volunteers and patients with rheumatoid arthritis (RA). A favourable safety profile, predictable pharmacokinetics and confirmed target engagement support further clinical development of SOL-116 as a potential therapy for RA.
Lipum is developing SOL-116, an innovative biological drug that targets BSSL - a protein involved in inflammation. The drug candidate is primarily being evaluated for the treatment of rheumatoid arthritis, whilst applications for other inflammatory diseases with a high unmet need are also being explored.
Lipum announced the publication of the Clinical Study Report for its Phase I trial evaluating SOL-116. The study investigated single ascending doses (SAD) and multiple doses (MD) of SOL-116 in healthy volunteers, as well as a single dose in patients with mild rheumatoid arthritis (RA).
SOL-116 was well tolerated across all dose levels, with no serious adverse events deemed related to the investigational drug. Exploratory results demonstrated reduced levels of BSSL in participants receiving SOL-116, suggesting direct on-target activity. The study also showed predictable pharmacokinetics and anti-drug antibodies (ADA) were detected in only one patient, who reverted to ADA-negative at the subsequent measurement.
"It is encouraging to see how Lipum is approaching the initiation of a Phase II study. These robust Phase I results strongly support continued development of SOL-116, and as Lipum has GMP manufacturing underway, we are confident that the development will be efficiently executed going forward," comments Karl Elmqvist, Investment Manager and Head of Flerie's Product Development segment.
For more information:
Karl Elmqvist
Email: ir@flerie.com
Flerie in brief
Flerie is an active long-term life science investor, with a broad and diversified portfolio of innovative companies based on pioneering science. We invest in product development and commercial growth opportunities globally alongside other leading investors, focusing predominantly on private companies that are otherwise difficult to access. Flerie's active ownership model, broad network and resources support and accelerate the development of the portfolio projects, creating value for shareholders. Flerie AB's ordinary share is listed on Nasdaq Stockholm with the ticker FLERIE. For further information please visit www.flerie.com
