Lipum approaches the finish line in the study – last patient recruited
Lipum has recruited all rheumatoid arthritis patients for the final stage of its phase I study with SOL-116. With a 90-day follow-up period remaining, the study is on track for completion around the end of the year. CEO Ola Sandborgh discusses this milestone in an interview.
Lipum is developing a novel biological drug with the potential to provide a safer and more effective treatment for rheumatoid arthritis (RA) and many other chronic inflammatory diseases. The company’s drug candidate, SOL-116, is a humanized antibody that blocks bile salt-stimulated lipase (BSSL), a previously overlooked target molecule in the immune system.
Since 2022, Lipum has conducted a phase I clinical study with SOL-116 in the Netherlands to evaluate the candidate’s safety, pharmacokinetics, and exploratory efficacy endpoints. The study is divided into three parts: a single ascending dose (SAD) phase, a multiple-dose (MD) group in healthy volunteers, and a single-dose group with eight RA patients. The first two parts have been completed with positive results, and now all patients have been included in the third and final part.
All patients have been recruited and dosed
The first RA patient was recruited for the study in early March 2024. Since then, the company’s CRO in the Netherlands has worked on recruiting and dosing the remaining patients. Late last week, Lipum announced that the last patient had been recruited and dosed with either SOL-116 or placebo. Before the study can be completed, a 90-day follow-up period for the patients remains.
Interim data from the first two parts of the study showed that SOL-116 is safe and well-tolerated, with few and no severe side effects. Furthermore, the results confirmed the expected pharmacokinetic profile and the fact that the treatment effectively reduces the target protein BSSL to undetectable levels.
Now, it remains to be seen what results the third and final part with RA patients will yield and what conclusions can be drawn from the study’s final results as a whole.
Lipum’s CEO discusses the milestone
BioStock contacted CEO Ola Sandborgh to learn more about the phase I study and his expectations for the final results.
First and foremost, how do you view the milestone of having recruited all patients for the phase I study?
– It is, of course, very gratifying that we have reached this point in the development program and that we will be able to receive a final report within a few months. The phase I study is important for several reasons – not only in establishing that we have a safe product with good tolerability but also that we are gaining essential insights that will be important for the ongoing development program and the phase II study, which we have already begun planning.
Why did you choose to include RA patients in the phase I study and not just healthy subjects?
– Early in developing SOL-116, based on preclinical research results, it became apparent that developing the antibody for RA would likely be a promising approach. Today, we have chosen RA as our indication for studying efficacy, so we felt it was valuable to include patients already in phase I. This provides us with critical insights that we can carry into developing and optimizing the phase II study.
What were the biggest challenges in recruiting RA patients for the study, and how did you overcome them?
– Recruiting patients for studies is always a challenge. Of course, the inclusion and exclusion criteria must be met, and the patient must also be willing to participate in a study involving a new drug. Collaboration with our CRO and trial centers was key, and it was also important to conduct the right activities, such as information campaigns on social media and in local newspapers, which are crucial for recruiting patients to participate.
How do you plan to adjust dosing for the upcoming phase II study based on the results from the SAD and MAD parts?
– It is too early to comment on that, as we are still analyzing the collected data, which will play a significant role in designing the upcoming phase II study.
What are your expectations for the final report of the study?
– We expect SOL-116 to continue demonstrating that it is a safe and well-tolerated product, allowing us to move confidently into the next phase. We need to receive a final report that provides all the support we need to optimize the upcoming stages of the development program. The interim results we shared earlier this year suggest this will be the case, but of course, the final report is the decisive factor and will be our definitive guide.
