Lipum reports Q2 and increases the pace
In the report for the second quarter, biopharmaceutical company Lipum announces that they are increasing the pace of development of SOL-116 for rheumatoid arthritis. The clinical phase I study with the candidate is progressing according to plan and the company has identified a possibility to accelerate the second part of the study. With financial resources in place, the company looks forward to reporting results from the study in early 2024.
Lipum is developing the drug candidate SOL-116, a human antibody that blocks Bile Salt-Stimulated Lipase (BSSL), which is a new way to treat chronic inflammatory diseases. The company focuses primarily on the treatment of rheumatoid arthritis (RA).
Lipum is currently conducting a clinical phase I study in the Netherlands with SOL-116 to evaluate safety and tolerability. In addition, the study investigates possible differences between healthy subjects and RA patients in how SOL-116 is metabolised in the body and the level of inflammatory biomarkers.
Increasing pace of the phase I study
During the spring, the company announced that the first part of the phase I study (Single Ascending Dose study) is progressing according to plan and that the results look promising – SOL-116 is safe and well tolerated. No serious side effects have been reported.
This positive development means that the second part of the study (Multiple Dose study) can start earlier than expected. In close collaboration with its CRO, Lipum has restructed the study’s design and protocol, paving the way for a faster progress plan.
Sufficient cash to complete the study
To enable an accelerated study plan, the company carried out a rights issue in July that raised 15.3 MSEK. Prior to this, the company’s cash amounted to 12.4 MSEK according to the company’s Q2 report.
The capital raise allows the company to complete the study earlier than planned. The current capital is expected to last until Q1, 2024. Thereafter, additional capital is needed for phase II, which can be covered by another capital raise and/or EU funding. The company has applied for funding from the EU’s EIC Accelerator program, which supports innovative and breakthrough project ideas with funding from the European Innovation Council (EIC).
Parallel study parts during the autumn
With Dutch authorities’ approval, Lipum is ready to start the second part of the study where healthy subjects will receive multiple doses of SOL-116. The aim is to continue studying safety, tolerability and pharmacokinetics. A cohort of eight subjects is considered sufficient, but an additional group may be required.
In parallel, the last part of the SAD study is underway, where eight RA patients will receive a dose of SOL-116 or placebo. The first dose was delayed due to inclusion criteria being too strict, this has now been adjusted and two new clinics have been engaged to facilitate patient recruitment.
Deepening knowledge of BSSL
In addition to the clinical study, Lipum has been studying SOL-116 and BSSL’s role in inflammation. The company’s preclinical results were recently published in the renowned scientific journal PLOS ONE, which strengthens the credibility of the research. The peer-reviewed article describes how the target molecule BSSL affects the recruitment of inflammatory cells.
To deepen the knowledge about BSSL, the company has initiated a two-year collaboration with researchers at Karolinska Institutet (KI), who are now recruiting a post-doc to the project. In addition, the company has dialogues with Linköping University and Uppsala University regarding studies on BSSL on tissue samples from their biobanks.
Exciting news ahead
The main focus going forward for Lipum is to complete the ongoing clinical study and plan for the continuation. The company has received positive feedback on the plans for phase II at an advisory meeting with the Medical Products Agency. The goal is to be able to initiate a phase II study within approximately 18 months.
To prepare for further development, Lipum has recruited Christian Antoni to the Scientific Advisory Board and Karin Franck-Larsson as new Chief Medical Officer. In addition, Carl-Johan Spak, senior advisor at the company’s largest shareholder Flerie Invest, has been elected as a new board member.
With a strengthened team and strengthened financial resources, Lipum looks forward to reporting more interesting news to the market in the second half of 2023.
Watch CEO Einar Pontén’s company presentation from BioStock Life Science Spring Summit and listen to BioStock‘s podcast Coffee Break.
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.
