– The phase I results give us strong confidence as SOL-116 progresses to the next stage of development, says Karl Elmqvist.
Lipum is developing a biological drug with a novel mechanism of action for the treatment of chronic inflammatory diseases. It’s lead drug candidate, SOL-116, is specifically designed to inhibit Bile Salt-Stimulated Lipase (BSSL), a protein shown to play a key role in the body’s inflammatory response.
The company’s initial focus is on rheumatoid arthritis (RA), though SOL-116 is also being evaluated for other inflammatory conditions with high unmet medical needs and limited effective treatment options.
Lipum has recently completed a phase I clinical trial demonstrating that SOL-116 has a favorable safety profile and predictable pharmacokinetics in both healthy volunteers and patients with RA.
First-in-Human study shows positive results
The phase I study was conducted in three parts: two involving healthy volunteers who received single ascending doses (SAD) or multiple doses (MD) of SOL-116, and a third involving patients with mild RA who received a single dose. All participants were monitored for 90 days to thoroughly assess safety and pharmacokinetics.
The results demonstrated that SOL-116 was well tolerated across all dose levels, with no serious drug-related adverse events reported. The pharmacokinetic profile aligned with expectations and supports a once-monthly dosing regimen. Exploratory analyses also showed a reduction in BSSL levels among participants treated with SOL-116, indicating a direct on-target activity.
These encouraging results lay the foundation for the next phase of development – a larger phase II trial in RA patients aimed at evaluating efficacy, optimising dosing, and gaining deeper insight into the drug’s mechanism of action in patients with active, moderate to severe disease.
Flerie – majority owner of Lipum
The development of SOL-116 is made possible by strong shareholder support and capital raises directed toward both existing and new investors, as well as public funding from Swedish and European grant programs.
Lipum’s largest shareholder is the investment company Flerie, currently holding approximately 57 percent of the company’s share capital. Flerie was founded in 2011 by Thomas Eldered, co-founder and former CEO of Recipharm, one of the world’s five largest CDMO companies. Following the multi-billion-euro acquisition of Recipharm by EQT in 2021, Eldered directed the proceeds into building an investment portfolio of promising life science companies. Today, Flerie holds investments in 27 companies and has been listed on Nasdaq Stockholm since 2024.
Flerie shows confidence ahead of phase II start
Flerie became a major shareholder in Lipum by acquiring all shares and warrants from Almi Invest in 2021. At the time, Lipum’s drug candidate was in late preclinical phase. Following a successful phase I study, SOL-116 is now ready to enter phase II.
Karl Elmqvist, Investment Manager and Head of Product Development at Flerie, views the upcoming step positively:
– 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.
The manufacturing of the investigational drug product for phase II is being carried out by NorthX Biologics, where Flerie is the majority owner with 92 percent of the shares.
Flerie’s Investment Manager
Karl Elmqvist has been an Investment Manager at Flerie since 2022 and recently also assumed the role of Head of Product Development. He holds a medical degree (MBBS BSc) from Imperial College London, where he also spent a year at the business school. His previous experience includes working as a doctor at St Thomas’ Hospital in London, as well as at the digital health company Doctrin.
In addition to his role at Flerie, Karl is actively involved in several of the firm’s portfolio companies. He serves as a board member at Strike Pharma and Sixera Pharma, and as a board observer at AnaCardio.
BioStock spoke with Karl to gain insight into his role at Flerie and to hear his perspective on Lipum’s progress and the company’s current stage of development.
Could you start by sharing a bit about your role at Flerie and how your background helps in evaluating drug projects and potential investment opportunities?
– We have divided our portfolio into two main segments: Product Development, which includes primarily preclinical and clinical-stage drug projects, and Commercial Growth, which covers more mature companies with products already on the market. I am responsible for the development companies, but we are a small team at Flerie, and everyone actively supports the entire portfolio. My background in medicine helps me navigate the science, but also to better understand patient needs. I have also been able to leverage my network in London, where there are several world-leading experts affiliated with Imperial and St Thomas’.
Flerie has provided strong financial backing to Lipum since becoming a major shareholder in 2021. What does your continued, long-term involvement look like going forward?
– Lipum is at a very exciting stage, having completed its phase I study and now preparing for the next phase of development. As the largest shareholder, we are committed to supporting the company through our active ownership model.
Beyond financial support, what other types of value do you bring to the table?
– We maintain close relationships with our portfolio companies, both formally through board representation and informally by encouraging collaboration and knowledge sharing. We leverage our broad network and hold regular meetings with specialist investors and potential partners. In that sense, we see ourselves not just as investors, but also as ambassadors for the companies we support.
Lipum recently completed its phase I study with promising results and is now preparing for phase II. From an investor’s perspective, how do you view the company’s position and potential at this stage?
– The immunology and inflammation (I&I) space is currently attracting strong interest from both investors and large pharmaceutical companies. Lipum’s drug candidate, which demonstrated a favorable safety profile in phase I, exemplifies what we refer to as a ‘pipeline in a product’ – it has the potential to be applied across multiple inflammatory diseases beyond rheumatoid arthritis. That is something we find incredibly exciting, especially given the significant need for new treatment options in this area.
How does Lipum fit into Flerie’s overall investment strategy? Are there any particular similarities or differences compared to other companies in your portfolio?
– Lipum aligns well with our strategy of supporting early-stage biotech companies as they approach key clinical inflection points – such as the transition to larger trials designed to demonstrate efficacy, where significant value is often unlocked. While Lipum is publicly listed, the majority of our portfolio consists of private companies. That said, we maintain an active engagement model across both public and private investments.
CEO discusses milestone achievement
BioStock also spoke with Lipum’s CEO, Ola Sandborgh, to learn more about the recent progress and preparations for the planned phase II study.
How does it feel to have completed the phase I chapter and to be able to focus on the next step in SOL-116’s development?
– It is obviously very gratifying. Each milestone achieved is crucial in our journey toward the ultimate goal of providing a new treatment option for patients who are not helped by existing alternatives. The phase I study is particularly significant as it marks the first time we have studied SOL-116 in humans. The results we have obtained are as positive as one could reasonably expect from a phase I study. We have thus received the answers we need to proceed to the next step, phase II.
What impact has Flerie’s long-term commitment had on your journey so far?
– Flerie, as a high-quality specialist investor, contributes from multiple perspectives. Financial support is one aspect, but access to their network, the opportunity to receive qualified support on various issues, and being part of their group of portfolio companies has been incredibly valuable to us.
Finally, can you tell us more about the patient group you plan to focus on in phase II, and why these patients have a particularly high need for new treatment options?
– We will evaluate efficacy, optimize dosing strategies, and deepen our understanding of the drug’s mechanism of action in patients with active, moderate to severe rheumatoid arthritis. While several treatments are already available – including TNF-α and JAK inhibitors – we know that 30 to 40 percent of patients do not experience adequate relief. The unmet medical need in this population remains significant, and that’s precisely what we aim to address with SOL-116, a candidate we believe has groundbreaking therapeutic potential..
