Lipum has included first RA patient
Lipum recently announced that the first patient with rheumatoid arthritis has been included and dosed in ongoing phase I clinical trial with SOL-116 in the Netherlands. Previously, only healthy subjects were included in the study, but now the first patient has received a dose of SOL-116 or placebo. To find out more, we contacted Lipum’s Clinical Project Leader, Agneta Wennerholm, who is involved in the design and project management of the study.
The Swedish biopharmaceutical company Lipum is driving the development of the drug candidate SOL-116 – a humanised antibody that blocks Bile-Salt Stimulated Lipase (BSSL), which is a previously overlooked target molecule of the immune system.
SOL-116 has the potential to provide millions of patients suffering from chronic inflammatory diseases with a safer and more effective treatment. Initially, the company’s focus is directed towards treatment of rheumatoid arthritis (RA).
Progress in First-in-Human study
The company is currently conducting a double-blind, randomised and placebo-controlled clinical phase I study evaluating the drug candidate’s safety, pharmacokinetics and exploratory effect markers.
The company has announced positive safety and pharmacokinetic results from the first part of the study – single dose escalation (SAD) in five groups of healthy subjects. The second part includes a group of eight healthy subjects receiving multiple doses of SOL-116, and this part is expected to be completed in March.
In addition, the company recently started the third and final study phase where eight patients with RA will be included. The first patient has been included and dosed, which means that the company is one step closer to the completion of the study and thus the next phase in development.
Interview with Agneta Wennerholm
About two years ago, we talked to Agneta Wennerholm about the preparations for the phase I study and the collaboration with the company’s CRO in the Netherlands. Now, as the study approaches its conclusion, BioStock has taken the opportunity to once again ask her some questions.
You have now initiated the final part of the phase I study, which includes RA patients. How does it feel now that the study is approaching its conclusion?
– We are very pleased to have reached the milestone of the first RA patient dosed, thus nearing the end of the study and analysis of collected data. The clinic, Lipum team, and CRO have collaborated well to achieve this.
What are the most exciting observations from the study so far?
– The preliminary data we have obtained so far look promising both in terms of safety and pharmacokinetics in healthy volunteers. We have also been able to demonstrate that SOL-116 reduces BSSL levels (our target protein) in plasma in healthy volunteers.
What insights and results do you expect to achieve in the part of the study involving RA patients?
– We are very interested to see if the pharmacokinetics and safety data correspond between patients with RA and healthy volunteers.
Finally, what are you currently focusing on in the planning for phase II?
– There is a broad focus right now; planning for the evaluation of the phase I study, discussions about phase II study design, meetings with external clinical advisors, scheduling, planning for CRO procurement, and much more.
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.
