Lipum successfully completes study – CMO looks ahead to the next chapter
Lipum has successfully completed its phase I clinical study with positive results. The study confirms that the drug candidate SOL-116 is safe, exhibits the expected pharmacokinetics, and effectively inhibits the target protein BSSL in both healthy volunteers and patients with rheumatoid arthritis. Additionally, the findings suggest that a once-monthly administration is an optimal dosing regimen. The company’s CMO, Peter Hovstadius, discusses the results in an interview.
Lipum is a biopharmaceutical company based in Umeå, specializing in the treatment of chronic inflammation. The company has developed a biological drug candidate, SOL-116, which blocks Bile Salt-Stimulated Lipase (BSSL), a previously overlooked target molecule in the immune system.
With SOL-116, Lipum aims to provide an effective and safe treatment for rheumatoid arthritis (RA) and other chronic inflammatory diseases. The company has now reached a significant milestone on this path – its phase I clinical study has been successfully completed with positive results. A full clinical study report is expected to be available by the end of March 2025.
Confirms the drug candidate’s safety
For approximately two years, the contract research organisation QPS has conducted a randomized, double-blind, placebo-controlled study in the Netherlands with SOL-116 in both healthy volunteers and patients with rheumatoid arthritis (RA).
The study was divided into three groups: 40 healthy volunteers assigned to five single-dose groups, 8 healthy volunteers receiving multiple doses, and 8 RA patients receiving a single dose.
The primary endpoint was to demonstrate safety and tolerability, which was successfully achieved. Subcutaneous injection of SOL-116 was well tolerated at all dose levels, with no treatment-related serious adverse events observed. Most reported adverse events were mild, except for two classified as moderate. No clinically significant abnormalities were identified in laboratory tests, vital signs, ECG, or other assessments.
BSSL is effectively supressed
The study also included secondary endpoints to evaluate pharmacokinetics and immunogenicity, as well as exploratory efficacy measures to assess the impact of SOL-116 on BSSL levels in the blood. The exploratory analyses confirm that SOL-116 effectively inhibits BSSL in both healthy volunteers and RA patients.
A single dose of SOL-116 eliminated BSSL levels in the blood from day 4 to day 90 in healthy individuals, which aligns with the treatment objective. Participants who received multiple doses (four doses at 28-day intervals) had undetectable BSSL levels by day 169, except for one participant who showed a measurable BSSL level on day 95.
Among RA patients, 50 percent had measurable BSSL levels at baseline. Following treatment, 7 out of 8 patients showed absent BSSL levels from day 22 to day 90.
Once-monthly dosing
The analysis of SOL-116’s pharmacokinetics supports a dosing frequency of once per month. The drug candidate had a half-life of approximately 20 days. The median time to reach maximum concentration of SOL-116 ranged from 5.1 to 7.2 days, depending on the dose level.
Both systemic exposure and maximum concentration increased proportionally with the dose, indicating a predictable pharmacokinetic profile.
Immunogenicity analyses detected anti-drug antibodies (ADA) in only one RA patient. However, at the next measurement on day 90, the patient no longer had ADA. In the healthy subjects who received SOL-116, ADA could not be detected at any time point.
Preparing for the next development stage
Lipum is now working on analyzing the complete dataset, including exploratory efficacy measures such as inflammatory biomarkers. The results will form the basis for the company’s ongoing clinical development strategy and the next clinical trial – a phase II study to demonstrate the efficacy of SOL-116.
In parallel, the company plans to initiate discussions with regulatory authorities and external advisors to optimize the development plan.
CMO responds
The company’s CMO, Peter Hovstadius, commented on the study results in the company’s press release:
– We are very pleased with the results from our phase I study, which confirm that SOL-116 has a favourable safety and pharmacokinetic profile in both healthy subjects and patients with RA. These results support the continued development of SOL-116, and we look forward to advancing to the next clinical phase.
BioStock reached out to Peter Hovstadius for a deeper insight into the study results.
Were there any results in the study that surprised you?
– We had high expectations for SOL-116’s safety and pharmacokinetic profile, but it was encouraging to see how consistently and persistently BSSL was eliminated from the blood. What stood out was that a single dose could keep BSSL at undetectable levels for up to 90 days in healthy participants. This strengthens the hypothesis that we can achieve effective treatment with a relatively low dosing frequency. Another positive observation was that immunogenicity was very low, which is a crucial factor for biological drugs.
The study results indicate that administering SOL-116 once a month is a viable option. How do you think this dosing frequency aligns with patient needs?
– Monthly dosing is clearly advantageous from a patient perspective. Many of today’s biological RA treatments require dosing every week or every other week, which can be burdensome for patients. Being able to administer SOL-116 once a month would offer a more convenient treatment option, potentially improving treatment adherence.
»Monthly dosing is clearly advantageous from a patient perspective. Many of today’s biological RA treatments require dosing every week or every other week, which can be burdensome for patients.«
Could you elaborate on the findings in the study that support the one-month dosing interval?
– Pharmacokinetic analyses show that SOL-116 has a half-life of approximately 20 days, meaning the drug remains in the system for a long period. The median time to maximum concentration was between 5.1 and 7.2 days, confirming stable and slow absorption. Additionally, we observed that BSSL levels were undetectable for up to 90 days after a single dose, and with repeated doses, levels remained absent for 169 days, with only one outlier. Taken together, this data strongly supports that a once-monthly dosing frequency is appropriate.
You observed no serious side effects, only mild and a few moderate ones. Can you specify the types of side effects noted?
– No treatment-emergent serious adverse events (TESAEs) were observed in those who received SOL-116. The reported adverse events (TEAEs) were similar between those who received active treatment and those who received a placebo. Most side effects in the SOL-116 group were mild, with only two cases classified as moderate.
– The most common side effects in the SOL-116 group were injection site reactions, headaches, and back pain. In the placebo group, back pain and fatigue were among the reported effects. All participants, except for one in the placebo group during the multiple dosing phase, completed the study.
How does SOL-116’s safety profile compare to existing RA treatments?
– The preliminary safety profile of SOL-116 looks very promising compared to existing biological drugs. We have not observed any serious side effects, significant immunogenicity, or deviations in clinical lab values. Many existing biological drugs are associated with an increased risk of infections and immune-related reactions, but so far, we have not seen such signals with SOL-116. Of course, we need to evaluate this further in phase II, but the early results indicate very good tolerability.
What does the overall timeline look like for the continued development program of SOL-116?
– We are in a crucial phase where we are now analyzing all data from the phase I study to gain a comprehensive understanding of SOL-116’s safety and pharmacokinetic profile. The full clinical report is expected to be completed by the end of March 2025, while we prepare for the next step – a phase II study. This will be a proof-of-concept study, where we for the first time will obtain clinical data on how SOL-116 performs in the treatment of RA.
»We are in a crucial phase where we are now analyzing all data from the phase I study to gain a comprehensive understanding of SOL-116’s safety and pharmacokinetic profile. The full clinical report is expected to be completed by the end of March 2025«
– We plan to initiate phase II in the first quarter of 2026 and are looking forward to advancing SOL-116 in the development process, with the goal of improving treatment options for people living with chronic inflammation.
What do you see as the biggest challenges when transitioning from Phase I to Phase II?
– The biggest challenge is designing a study that best evaluates SOL-116’s efficacy in RA patients. We will place great emphasis on ensuring a well-balanced and robust design that provides the most reliable and clinically relevant results. This means carefully defining the right patient population, optimal dose levels, and relevant efficacy measures to objectively assess the drug’s potential.
– Another important factor is patient recruitment, as competition for study participants in RA is high. At the same time, we are working to meet regulatory requirements in the best possible way to ensure a smooth transition to phase III if the results from phase II are positive. The goal is to conduct a study that provides a clear and fair assessment of SOL-116’s efficacy and its potential role in future RA treatment.
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