Lipum presents promising phase I data at ACR 2024
Lipum will present positive data from the phase I study of its drug candidate SOL-116 at the American College of Rheumatology (ACR) Annual Meeting 2024, a leading global conference in rheumatology. The interim results confirm that SOL-116 demonstrates a favourable safety profile and pharmacokinetics in line with expectations. The study approaches its conclusion, and Lipum plans to share the final report in the first quarter of 2025.
SOL-116 is a humanized antibody developed by Lipum for the treatment of chronic inflammatory diseases. The candidate specifically targets the protein Bile Salt-Stimulated Lipase (BSSL), which plays a central role in inflammation processes by promoting cell recruitment and migration of inflammatory cells.
Lipum has demonstrated that BSSL is linked to chronic inflammation in diseases such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), and psoriatic arthritis (PsA). By blocking BSSL with SOL-116, Lipum aims to potentially offer a novel treatment that combines an effective mechanism of action with a reduced negative impact on the immune system compared to current therapeutic options.
– This novel approach could meet an unmet need in chronic inflammatory diseases by offering a targeted mechanism to reduce disease activity with minimal side effects, writes Lipum’s CEO, Ola Sandborgh, in the company’s latest press release.
Lipum showcases progress at conferences
The company is currently evaluating its drug candidate’s safety, tolerability, and pharmacokinetics in a double-blind, placebo-controlled phase I clinical study. After nearly two years of work, the project is nearing its final stages.
Results from the study will be presented at this year’s American College of Rheumatology (ACR) Annual Meeting 2024, one of the world’s leading conferences in rheumatology. This event attracts thousands of healthcare professionals, researchers, and industry experts to discuss the latest advancements in diagnosing and treating rheumatic diseases. The conference takes place November 14–19 at the Walter E. Washington Convention Center in Washington, D.C.
You can read the abstract for Lipum’s poster presentation at ACR 2024 here.
Lipum is also participating in Lund’s BioStock Life Science Summit this week. The company’s CEO, Ola Sandborgh, will present the latest developments and answer questions on Thursday, November 21, at 9:50 AM. Sign up here to attend! For those unable to join live, a presentation recording will be available on BioStock’s YouTube channel after the event.
The results in detail
At the conferences, Lipum is presenting positive interim results from both the single ascending dose (SAD) group and the multiple-dose (MD) group of healthy volunteers in the phase I study. The findings demonstrate that SOL-116 is well-tolerated, with no reported severe adverse effects at any dose level. Pharmacokinetic data aligned with expectations, confirming that SOL-116 is efficiently absorbed and has a half-life of 20 days, supporting a long-lasting therapeutic profile.
Additionally, SOL-116 effectively eliminates the target protein, BSSL, in blood plasma, reducing it to undetectable levels from day 4 post-administration. None of the participants showed signs of developing anti-drug antibodies (ADA), highlighting a low risk of immunogenicity.
These findings underscore the antibody’s potential for long-term treatment, which could mean fewer dosing occasions and greater patient convenience.
The study also includes a cohort of patients with rheumatoid arthritis (RA). The follow-up period for this patient group is still ongoing, and all analyses and compilations are expected to be completed by early 2025.
Planning for phase II study
Peter Hovstadius, who joined Lipum as CMO in August, explains that the results provide strong support for advancing SOL-116 in clinical development:
– We are encouraged by the favourable safety and pharmacokinetic profile of SOL-116, which provides strong support for its continued clinical development in rheumatoid arthritis, says Dr. Hovstadius.
The next step is a phase II clinical study aimed at assessing the drug candidate’s effect on RA patients while continuing to ensure a good safety profile. Insights from the phase I study, such as dosing and dosing intervals, will be crucial for designing the study. Lipum has begun planning the study and initiated the process for drug manufacturing in collaboration with its partner NorthX Biologics. According to the company, the collaboration is progressing as planned.
These advancements are reflected in the CEO Ola Sandborgh’s comments in the latest financial report, which is concluded with:
– So far, 2024 has been an amazing journey, with results going our way and in the right direction. This is due to a knowledgeable and dedicated team that delivers every day in line with our values and strives to make a difference. I extend a heartfelt thank you to all employees and partners – together, we ensure the continued successful development of SOL-116.
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