BSSL – a novel target for treatment of autoimmune inflammatory diseases

Lipum has identified a unique target for treatment of chronic inflammatory diseases. It is a protein denoted bile salt-stimulated lipase (BSSL). It was concluded that BSSL acts by promoting recruitment of inflammatory and immune cells to the site of acute inflammation, which in the normal case helps to control the inflammation.

However, when an inflammation becomes “chronic” the effect of BSSL instead contributes to sustaining the inflammation. This makes BSSL a novel, and so far overlooked, target for treatment of chronic inflammatory diseases such as rheumatoid arthritis. Our therapeutic approach is to develop an antibody that blocks the function of BSSL –  thereby inhibiting the inflammatory process.

The efficacy has been demonstrated in several different animal inflammation models. Both animals devoid of BSSL (knock out mice) and animals treated with an antibody directed towards BSSL are effectively protected from disease development and progression.

A biological drug

The active ingredient will be a new biological drug, a unique monoclonal antibody targeting the BSSL molecule and inhibiting its action. The fact that it is an antibody, as are the TNFα inhibitors, will be an advantage when it comes to clinical implementation.

Lipum has developed a strong candidate drug (SOL-116) which is a fully humanised monoclonal anti-BSSL antibody.

In progress

Lipum has collected original research data proving the efficacy of the compound in several established arthritis models. The BSSL antibodies effectively block human inflammatory cell migration. A cell line for SOL-116 has been developed by our partner Abzena and production development in progress will lead to manufacturing of GMP material during 2020. In parallel, there will be toxicology studies and the clinical program shall start during 2021, leading to a clinical proof of concept after Phase II in 2022.

Orphan drug designation

Lipum’s proposed treatment and drug candidate can qualify for an orphan drug designation (ODD). Lipum is evaluating the possibility to address Juvenile Idiopathic Arthritis (JIA) as the first indication for the product.

DRUG DEVELOPMENT

The BSSL Molecule