2021 was an eventful year for Lipum with several achieved milestones in the preparation for the first clinical trial with the biological drug candidate SOL-116 for the treatment of chronic inflammatory diseases. Another significant milestone during the year was, of course, the listing on Nasdaq First North Growth Market. Lipum is now looking forward to 2022 when the company enters the clinical stage, which CEO Einar Pontén tells us more about in an interview with BioStock.

Lipum has developed the drug candidate SOL-116. It is an antibody that blocks the protein Bile Salt-Stimulated Lipase (BSSL), making it a new way to treat chronic inflammatory diseases. The company’s development is primarily focused on the treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA).

Lipum is in the late preclinical phase with SOL-116 and plans to start a phase Ia clinical study in 2022 on healthy volunteers to evaluate the candidate’s safety and pharmacokinetics.

Preparations for the first clinical study with SOL-116

The main focus in 2021 for Lipum was the preparations for the upcoming clinical trials with SOL-116. Toxicology and safety pharmacology studies have been carried out according to plan in collaboration with the CRO Charles River Laboratories, and the results from this work have been satisfactory. In September, a final study was initiated according to Good Laboratory Practice (GLP), and, once the evaluation of that study is complete, a clinical trial application (CTA) can be submitted.

During the past year, Lipum also produced SOL-116 according to the requirements of Good Manufacturing Practice (GMP). The production has taken place at Lipum’s CMC partner Abzena in San Diego, and the material is expected to be sufficient to conduct the first planned clinical trials in the program.

Listing on Nasdaq First North and successful capital raise 

In April 2021, Lipum was listed on Nasdaq First North Growth Market, which increased awareness of the company and its drug candidate SOL-116. A sign of this came when the reputable investment company Flerie Invest acquired all of Almi Invest’s shares and warrants in Lipum and thereby became a new major shareholder in the company.

In connection with the listing in April, a share issue was carried out, which provided the company with approximately 85.7 MSEK before issue costs. The capital injection provided Lipum with financial resources to conduct the toxicology and safety pharmacology studies and GMP production for the upcoming phase Ia study, as well as further preclinical work on other chronic inflammatory diseases.

Strengthened organisation

For the upcoming clinical development with SOL-116, Lipum has not only strengthened its financial situation, but its organisation was also expanded in 2021. In November, Dr. Maria Wanderoy took on the role of Project Director for the development of SOL-116. Wanderoy has extensive experience and expertise in the entire drug development process and has previously held project management roles in AstraZeneca, Dicot and SDS LifeScience. Wanderoy also holds a PhD in neurochemistry and neurotoxicology from Stockholm University.

Earlier in the year, Lipum’s Board of Directors was also strengthened when Åsa Hansdotter and Ingemar Kihlström were appointed as board members. Åsa Hansdotter is an attorney-at-law and partner at HWF Advokater and Ingemar Kihlström has a background in corporate finance and as an associate professor of toxicology at Uppsala University.

FDA’s safety warnings for JAK inhibitors provided an additional spur

Even some external factors have spurred Lipum to continue to drive the development of SOL-116 for the treatment of rheumatism and other chronic inflammatory diseases. An example of this was when the FDA extended its safety warnings for JAK inhibitors, a drug group for oral treatment of chronic inflammatory diseases. Based on a review of adverse event data from a large safety clinical trial, the FDA concluded that there is an increased risk of heart-related events such as heart attack and stroke, cancer, blood clots anddeath when treated with JAK inhibitors. The FDA’s announcement is expected to reduce the use of JAKinhibitors, underlining the need for new treatment options.

Lipum is facing a new stage – clinical trials

All in all, many pieces of the puzzle fell into place for Lipum in 2021. The development work continued according to plan, and the company is soon ready to enter the clinical phase with its drug candidate SOL-116. BioStock contacted Lipum’s CEO Einar Pontén to get his thoughts on the past year and plans for 2022.

If you had to point out the single most significant event in 2021 for Lipum, what would it be and why? 

– Drug development means that many pieces of the puzzle must fall into place at the right time. We achieved all important milestones. It is clear that the listing on Nasdaq First North was a major event in the company’s development that made us better known and provided us with financial resources to implement our plans.

How would you sum up 2021 in three words?

– Successful, intense and promising.

What remains before Lipum can make the step from preclinical stage to clinical stage with SOL-116? 

– We plan to submit a clinical trial application (CTA) in the spring with the aim of starting Lipum’s first clinical trial during the year. This, of course, involves a lot of work with analysis, evaluation and documentation of various results, including from pharmacology, toxicology and safety pharmacology studies and refinement of the clinical study plan. The drug candidate SOL-116 is formulated in a preparation with GMP quality and will be filled in vials and analysed in different ways to be verified before the study.

»We plan to submit a clinical trial application (CTA) in the spring with the aim of starting Lipum’s first clinical trial during the year«

What milestones are you looking forward to achieving in 2022?

– The most important and clearest milestone is, of course, the start of the clinical development program. At the same time, this means that we have completed a very resource-intensive preclinical work on the development of SOL-116, giving us greater freedom. The plan is that we will continue to evaluate further chronic inflammatory diseases in preclinical studies and develop our understanding of SOL-116’s mechanism of action. I expect that we will be able to present both exciting and value-enhancing results from this work during the year.

»I expect that we will be able to present both exciting and value-enhancing results from this work during the year«

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