Swedish biotech company Lipum has successfully concluded its Phase I clinical trial for SOL-116, an innovative biological drug candidate targeting Bile Salt-Stimulated Lipase (BSSL), a protein involved in inflammatory processes. The company is now preparing to advance the treatment into Phase II studies with continued support from its largest shareholder, Flerie AB.
The completed Phase I trial evaluated SOL-116 in both healthy volunteers and patients with rheumatoid arthritis (RA), demonstrating a favorable safety profile and confirming target engagement that supports further clinical development.
Phase I Trial Design and Results
The clinical study investigated single ascending doses (SAD) and multiple doses (MD) of SOL-116 in healthy volunteers, as well as a single dose administration in patients with mild rheumatoid arthritis. According to the final Clinical Study Report, SOL-116 was well-tolerated across all dose levels, with no serious adverse events deemed related to the investigational drug.
Pharmacokinetic data from the trial showed predictable behavior of the drug in the body. Importantly, exploratory results demonstrated reduced levels of BSSL in participants receiving SOL-116, suggesting direct on-target activity of the treatment. Anti-drug antibodies (ADA) were detected in only one patient, who subsequently reverted to ADA-negative at the following measurement, indicating minimal immunogenicity concerns.
"The phase I results give us strong confidence as SOL-116 progresses to the next stage of development," said Karl Elmqvist, Investment Manager at Flerie AB, highlighting the significance of these findings for the program's future.
Strategic Backing from Flerie
Flerie AB, an active long-term life science investor with a diversified portfolio, has played a crucial role in supporting Lipum's clinical development program. As Lipum's largest shareholder, Flerie's involvement has been instrumental in the successful execution of the Phase I trial.
"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," Elmqvist added.
Novel Mechanism Targeting Inflammatory Diseases
SOL-116 represents a potentially significant advancement in the treatment of inflammatory conditions. The drug candidate's primary focus is rheumatoid arthritis, a chronic autoimmune disorder that affects approximately 1% of the global population and causes painful joint inflammation, progressive disability, and systemic complications.
By targeting BSSL, SOL-116 employs a novel mechanism of action that differs from current standard treatments for RA, which include conventional disease-modifying antirheumatic drugs (DMARDs), biologics targeting TNF-alpha and other inflammatory cytokines, and JAK inhibitors.
Beyond rheumatoid arthritis, Lipum is exploring applications for SOL-116 in other inflammatory diseases with high unmet medical needs, potentially broadening the therapeutic impact of this innovative approach.
Preparing for Phase II
With the successful completion of Phase I, Lipum is now focusing on preparations for Phase II clinical development. The company has already initiated GMP (Good Manufacturing Practice) manufacturing processes to ensure adequate supply of the investigational drug for upcoming trials.
Ola Sandborgh, CEO of Lipum, expressed optimism about the program's progress, noting that the Phase I results provide a solid foundation for advancing SOL-116 through the next stages of clinical development.
The Phase II program will likely focus on evaluating the efficacy and further characterizing the safety profile of SOL-116 in a larger population of rheumatoid arthritis patients, potentially including those who have inadequate responses to current standard therapies.
As Lipum moves forward with the development of SOL-116, the company's progress represents a potentially important advancement in the treatment landscape for rheumatoid arthritis and possibly other inflammatory conditions where new therapeutic approaches are urgently needed.
