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Lipum’s CEO comments on multiple-dose results in phase I

Lipum

Lipum’s CEO comments on multiple-dose results in phase I

20 June, 2024

Following the positive single-dose results from the phase I study evaluating SOL-116, Lipum is now presenting additional promising data. The multiple-dose part of the study is now complete, and the safety profile continues to look good. Recruitment is currently ongoing for the third and final part, which involves rheumatoid arthritis patients.

Umeå-based Lipum is developing SOL-116, a drug candidate that targets and blocks Bile Salt-Stimulated Lipase (BSSL). According to the company, this immune system target molecule has been overlooked until now. The goal is to develop a new safe and effective treatment for chronic inflammatory diseases, with an initial focus on rheumatoid arthritis (RA).

A phase I study with the candidate is currently underway, which will primarily determine whether SOL-116 is safe to use. Effects in RA patients will also be studied – this will be an important piece of the puzzle for the continued development.

Positive results from SAD reading

Last winter, Lipum announced positive results from the single ascending dose (SAD) part of the phase I study. Based upon those results, SOL-116 appears to have a good safety profile and desirable pharmacokinetics. The candidate also interacts well with its target protein BSSL and effectively reduces the levels of BSSL in blood plasma. Additionally, none of the participants developed antibodies against the drug, indicating that SOL-116 may have a long-lasting effect.

Interim analysis of multiple-dose data

In parallel, the company has also conducted the multiple-dose part (MD) of the study, where a group of eight healthy subjects received repeated doses of SOL-116 or placebo. They received four doses with 28-day intervals and a subsequent 90-day follow-up. In this part of the phase I study, the participants exhibited few and, importantly, no serious side effects, according to an interim analysis of the results.

The participants did not develop any antibodies against the drug during the study period, and the pharmacokinetics matched those observed in the SAD part. Furthermore, Lipum states that the observed exposure and maximum serum concentration after the last dose were at expected levels, which, according to the company, “confirms robust and predictable pharmacokinetics.”

With these results secured, Lipum is now focusing on the final part of the phase I programme in patients suffering from RA. Recruitment is currently underway for a group of 8 patients, who will receive a single dose of SOL-116.

CEO comments

Ola Sandborgh, CEO of Lipum

BioStock spoke to Lipum’s CEO Ola Sandborgh to learn more about the results and what lies ahead.

First and foremost, Ola, what is your take on the results from the MD part of your phase I study?

– In short, I would say they are encouraging and reassuring. We already saw in the analysis of the SAD part that SOL-116 was well tolerated and showed few to no serious side effects. To also obtain the same results in the MD part is very good and provides us with continued support and confidence in the development work. One result that stands out a bit more is that no individuals developed antibodies against SOL-116, which is very good as it suggests that SOL-116 can maintain its effect over time and reduce the risk of unwanted effects.

The new results confirm what you saw in the SAD part. Is there anything that differs?

–  Actually not, what we obtain with the MD part is extended knowledge as SOL-116 is given in repeated doses while the results we observed in the SAD part are maintained.

You write that exposure and maximum serum concentration observed after the last dose were in line with expectations. Why is that important?

– For us, it is extremely important to study and learn how SOL-116 behaves when administered to humans. Preclinical studies have obviously indicated what we can expect, but it is only when we step into clinical studies that we can get the real answer. In the MD part, details concerning exposure, serum concentration, half-life, and time to steady state are central. We have an idea of what we should be able to achieve, but now we know that the result also matches what we calculated and expected.

You are currently recruiting for the final part of phase I. How is the recruitment going and when do you expect to be able to report the results?

– Recruitment is ongoing, and we are currently in the final phase of that work. Our hope is to be able to share interim results from the RA part in the fall and that a full report from the entire phase I study will be available before the end of the year.

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.

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