Lipum’s CEO reflects on the year and comments on Eurostars funding
2024 was an eventful year for Lipum, setting the stage for an equally exciting 2025. The year kicks off with the final report from the clinical phase I trial of the drug candidate SOL-116, followed by preparations for a phase II trial to demonstrate treatment efficacy in patients with rheumatoid arthritis. Additionally, Lipum recently secured funding from Eurostars for a project with Age Labs, focused on predicting which patients are most likely to respond to the treatment.
Lipum aims to develop safer and more effective treatments for chronic inflammatory diseases. The company’s drug candidate, SOL-116, targets a novel target molecule: Bile Salt-Stimulated Lipase (BSSL), which plays a central role in the inflammatory process.
SOL-116 is being developed initially to treat rheumatoid arthritis (RA) but is also considered to have the potential for treating other inflammatory diseases.
Lipum and Age Labs receive Eurostars funding
Lipum recently received a grant from Eurostars for a development project in collaboration with Age Labs, a Norwegian epigenetics company specializing in biomarkers and tests for disease detection.
The project aims to develop a method for predicting which RA patients will achieve the best treatment outcomes with SOL-116. Initially, this could improve patient selection for upcoming clinical studies and provide clearer treatment results. In the long run, the technology could lead to a diagnostic test to identify patients’ likelihood of responding to the treatment.
The project’s budget is approximately EUR 1.9 million, with Eurostars covering 50 percent of the funding through grants from Vinnova and the Research Council of Norway. Feasibility studies on Lipum’s target molecule, BSSL, indicate promising opportunities to achieve the project’s goals, which will be valuable for the continued clinical development of SOL-116.
The phase I study is in its final stage
SOL-116 is being evaluated in a clinical phase I study involving healthy volunteers and RA patients. The study is now in its final phase, and during the year, Lipum has presented positive data showing that SOL-116 has a favorable safety and pharmacokinetic profile. Interim data were recently presented at the American College of Rheumatology (ACR) Annual Meeting 2024 —read more here.
All three parts of the study – single-dose and multiple-dose trials in healthy volunteers and the single-dose trial in RA patients – have been completed. Lipum is now underway with the data review, evaluation, and summarization. Final results for the entire study are anticipated in Q1 2025.
Preparations for phase II
Following the completion and reporting of the phase I study, the company will continue planning for a phase II study to evaluate the efficacy of SOL-116 and demonstrate proof-of-concept in RA patients. The goal is to conduct the phase II study during 2026–2027.
As part of the preparations, Lipum has initiated a collaboration with NorthX Biologics for the manufacturing of the investigational drug. Read more about the collaboration in BioStock’s interview with Janet Hoogstraate, CEO of NorthX Biologics.
Other key activities
Alongside clinical development, a research collaboration with Karolinska Institutet is underway to explore the role of BSSL in inflammation and to gain a deeper understanding of the mechanism of action behind SOL-116. Read BioStock’s interview with Bence Réthi, Project Leader learn more about the collaboration.
Lipum believes that BSSL may be involved in several inflammatory conditions. Rheumatoid arthritis has been chosen as the initial indication for studying SOL-116, but the company is also evaluating other diseases that could be treated with the drug candidate.
One example of this work is Lipum’s patent application filed in 2024 for SOL-116 to treat inflammation-driven cancer. The patent is based on studies showing that patients with breast cancer have elevated levels of BSSL, and that blocking BSSL with SOL-116 can inhibit the growth of cancer cells.
CEO reflects on the year and looks ahead
Lipum has strengthened its leadership team this year by recruiting Ola Sandborgh as CEO and Peter Hovstadius as CMO. BioStock reached out to CEO Ola Sandborgh to gain insights into the year’s achievements and plans for the future.
What lessons from 2024 will guide the continued development of SOL-116?
– There are several key takeaways. The first is that drug development takes time. After more than 30 years in the industry, I was well aware of this, but it is always important to fully understand and manage this reality. Of course, I would like things to progress faster, but a well-designed study and high-quality execution are crucial as they form the foundation for future steps.
– Another lesson relates to our need for funding. The macroeconomic environment requires us to adapt and improve how we communicate and present our project to investors. It also highlights the importance of optimizing our grant applications to programs such as Horizon Europe and Vinnova.
You have recently secured Eurostars funding for a project with Age Labs. How will this project support the development of SOL-116?
– The project is important from several perspectives. Initially, it supports our ongoing development program, but the final outcome will also be critical to future regulatory activities and subsequent commercialization.
– The ability to pre-select patients who are likely to respond to treatment is highly valued by physicians, investors, and regulatory authorities. Offering such a solution will add significant value to SOL-116 and its development.
What are the criteria for Eurostars funding, and what made your project meet the requirements?
– Eurostars is a funding program for small and medium-sized enterprises (SMEs) that collaborate on R&D projects to create innovative products or services for commercialisation.
– We qualified as an SME with a project in collaboration with Age Labs that aligns with Eurostars’ objectives. The competition is tough, but our application received high scores from three independent reviewers and a positive evaluation from an independent panel during the final stage of the process.
You have attended several partnering conferences, such as BIO-Europe, this year. When do you expect a partnership to be relevant?
– Most likely during the same timeframe as the phase II program. We are in regular contact with several potential partners, and many have expressed interest in reviewing phase II data before making decisions. This aligns with what we expected and is both reasonable and common.
SOL-116 seems to have potential in multiple therapeutic areas. How will you leverage these opportunities?
– Anti-inflammatory drugs generally have a wide range of potential applications, and we expect the same for SOL-116. The key is to focus on the right indications and allocate resources accordingly.
– We are actively identifying the most suitable indications while ruling out areas where the chances of success are low. This selection process combines results from preclinical studies with case-based assessments of medical need, feasibility for registration and launch, funding requirements, and profitability.
What goals are you aiming to achieve in 2025?
– Our primary goals are to complete the phase I study and prepare for the phase II study, ensuring it can start as planned in 2026.
– Additionally, securing funding to initiate and complete the phase II study is critical. Another important objective is to present a well-researched and verified explanation of SOL-116’s mechanism of action.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
