Throughout 2023, Lipum’s primary focus has been on the clinical phase I study with SOL-116. A mid-year capital raise empowered the company to further accelerate and a CEO transition was announced in the latter part of the year. Ola Sandborgh is now assuming the helm for the company’s next developmental phase, and BioStock reached out to delve into the plans for 2024.
Lipum has developed SOL-116, a biological drug candidate for the treatment of rheumatoid arthritis (RA) and chronic inflammatory diseases. The antibody blocks Bile Salt-Stimulated Lipase (BSSL), which is a promising new target molecule for treating chronic inflammation.
The role of BSSL in inflammation has been detailed in a scientific article published in the journal PLOS ONE in August. Learn more about this in BioStock’s interview with the company’s CSO and co-founder, Susanne Lindquist, here.
The phase I study accelerated during 2023
Throughout the year, Lipum has been conducting a clinical phase I study with SOL-116 to assess its safety, tolerability, and pharmacokinetics. The study progressed as planned, and during the summer, the company saw an opportunity to advance the second part of the study, where healthy subjects receive multiple doses of SOL-116 or placebo. To seize the opportunity to expedite the study, the company carried out a rights issue that raised 15.3 MSEK.
Strengthened the organisation
Ahead of phase II, Lipum has strengthened its team with Karin Franck-Larsson as CMO and Ola Sandborgh as the new CEO of the company. Ola assumed the role on December 1, while the former CEO, Einar Pontén, continues to work for Lipum in a role focused on business development. Read BioStock’s interview article about the CEO transition here.
Comments from CEO Ola Sandborgh
BioStock reached out to Ola Sandborgh to find out more about his first weeks as CEO of Lipum and what the plans look like for 2024.
From an external perspective, how would you describe the company’s progress over the past year?
– Lipum is evolving and growing rapidly. Today, the company is structured to effectively drive a clinical development program forward. The project for the drug candidate SOL-116 is progressing as planned, actually slightly ahead, as the multiple-dose part of the phase I study was able to commence earlier. Consequently, we can expect to get access to interesting data in the first half of 2024. The results, which still consist of blinded data, have so far led to the conclusion that SOL-116 is safe, well-tolerated, and exhibits desirable pharmacokinetics.
– In addition to the phase I study, a very important and requested scientific collaboration has been initiated with researchers at Karolinska Institutet (KI) and the Division of Rheumatology at the Department of Medicine. The research collaboration aims to thoroughly explore BSSL’s role in the immune system, especially its role in rheumatoid arthritis, and shed further light on the mechanism of action for the anti-BSSL antibody SOL-116.
»The project for the drug candidate SOL-116 is progressing as planned, actually slightly ahead, as the multiple-dose part of the phase I study was able to commence earlier […] In addition to the phase I study, a very important and requested scientific collaboration has been initiated with researchers at Karolinska Institutet (KI)«
How have your first weeks as CEO of Lipum been?
– Intense, orienting, and fun! I have been well taken care of and welcomed. The days have been filled with external meetings and contacts with both existing and potentially new shareholders. At the same time, I have also had various internal introduction meetings, board meetings, and had the opportunity to meet the research collaboration group at KI.
– 2023 is coming to an end, and many activities and processes for 2024 are being initiated. For me, this means a direct opportunity to start shaping the direction and focus for the upcoming years already.
Looking ahead, what milestones do you anticipate the company achieving in 2024?
– The completion of the entire phase I program is pivotal. There we will acquire crucial data regarding how SOL-116 is received and its impact on both healthy volunteer participants and patients with rheumatoid arthritis. We will also obtain results from biobank data regarding BSSL levels in various patient groups, along with preclinical data from studies on our new knock-in mice, i.e. mice that have human BSSL which is optimal for testing SOL-116. Additionally, I hope we can get the initial results from the collaboration with KI, with more to follow in 2025. Overall, I assess that we will achieve many significant milestones in 2024, both clinical and preclinical.
– Data and insights from the phase I program will, of course, be essential in refining the planning and development of a phase II program, where we aim to study the dosage and effectiveness of SOL-116 in patients with rheumatoid arthritis.
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.
»Overall, I assess that we will achieve many significant milestones in 2024, both clinical and preclinical. Data and insights from the phase I program will, of course, be essential in refining the planning and development of a phase II program«