Umeå-based Lipum has successfully completed the first part of the clinical phase I study where the drug candidate SOL-116 is tested in healthy subjects. The results confirm that SOL-116 continues to have a good safety profile and desirable pharmacokinetic profile. The candidate interacts with its target protein BSSL and reduces the levels of BSSL in blood plasma. Lipum’s CEO Ola Sandborgh tells us more about the results in an interview.  

Lipum is developing the drug candidate SOL-116 as a safer and more effective treatment for inflammatory diseases. This is possible because SOL-116 blocks Bile Salt-Stimulated Lipase (BSSL), a previously overlooked target molecule in the immune system.  

The company is currently focusing on the implementation of the phase I clinical study with SOL-116 evaluating safety and pharmacokinetics in healthy subjects, and soon also patients with rheumatoid arthritis (RA).  

Progress in both single and multiple dose groups

Lipum has completed the single ascending dose (SAD) part of the study, which included a total of 40 healthy volunteers divided into five dose groups, with increasing dosage in each group. 

In September, the company also initiated the multiple dose (MD) part of the study, where a group of eight healthy volunteers received repeated doses of SOL-116 or placebo. They were administered four doses with a 28-day interval, and the follow-up period of 12 weeks is currently ongoing. In the spring, the company will also include a group of RA patients in the study. 

Positive interim results

The interim results from the single dose study part indicate that SOL-116 is well-tolerated with few and only mild observed side effects in the study participants. Furthermore, the results showed that none of the participants developed immunogenicity after the administration of SOL-116, meaning they did not develop antibodies against the drug. 

If antibodies bind to a drug, it can prevent the substance from performing its function in the body. The absence of these anti-drug antibodies typically results in the drug remaining effective. 

Expected pharmacokinetic profile

Furthermore, SOL-116 demonstrates expected pharmacokinetics with good absorption in the body and a half-life of 20 days. The amount of the target protein BSSL was reduced to undetectable levels from day three after administration, a reduction maintained up to day 90 post-dosing.

The results suggest that SOL-116 is a potent antibody that binds to and effectively eliminates freely circulating BSSL after a single dose. 

Comments from CEO

According to Lipum’s CEO Ola Sandborgh, the interim results are an important milestone for Lipum. The results not only confirm the company’s expectations, but also provide valuable knowledge for the design of the phase II programme, where medical efficacy will be studied.  

BioStock reached out to Sandborgh to find out more about the study results. 

First and foremost, why is it important to demonstrate that SOL-116 reduces BSSL levels in plasma? 

– We know from preclinical studies of patient samples that the level of BSSL is elevated in rheumatoid arthritis, as well as in juvenile arthritis and psoriatic arthritis. Our results indicate that BSSL promotes and sustains inflammation, which is believed to be prevented by blocking BSSL with SOL-116. 

»Our results indicate that BSSL promotes and sustains inflammation, which is believed to be prevented by blocking BSSL with SOL-116.«

Have you made any additional observations regarding how SOL-116 affects other biomarkers and cytokines in the blood?  

– We have collected samples and obtained data on this, and we will continue to do so in the multiple-dose group and the group of RA patients. However, it is still too early to evaluate and draw any conclusions. 

You also mention that SOL-116 is well absorbed in the body and has a half-life of 20 days. How can this impact the drug’s effect?  

– Firstly, it provides predictability and guidance on, for example, how often one needs to take a dose and the amount needed to effectively block BSSL. Our goal is to have a medication that the patient can take once a month. 

You also plan to include a patient group with rheumatoid arthritis. What is particularly interesting about this part of the study?  

– Firstly, it provides us with an opportunity to investigate whether SOL-116 is safe and well-tolerated by RA patients as well as by healthy subjects. Additionally, we will be able to compare pharmacokinetics and levels of various inflammation biomarkers between patients and healthy subjects. 

»The interim results indicate that we have a very promising drug candidate for blocking the activity of BSSL. I hope that we will achieve similar results for patients«

Finally, what are you looking forward to achieving in the study during 2024? 

– The interim results indicate that we have a very promising drug candidate for blocking the activity of BSSL. I hope that we will achieve similar results for patients, and that the comparison with healthy subjects will provide us with valuable insights to design a robust pivotal efficacy study in phase II. 

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