Development of SOL-116

Lipum has identified a unique target protein for the treatment of chronic inflammatory diseases. This protein, called Bile Salt-Stimulated Lipase (BSSL), is responsible for stimulating the recruitment of certain blood cells to the site of inflammation to combat inflammation in the acute phase. The problem arises in the chronic phase when the body can no longer control the inflammation itself, and instead, BSSL contributes to its maintenance.

The significance of BSSL has been verified in four different and well-established animal models of arthritis in mice and rats. It has also been shown that animals administered with an anti-BSSL antibody become significantly less ill than controls, providing strong support for the idea of treating the inflammation by blocking the function of the protein. Furthermore, various studies have shown that mice that lack the gene for the BSSL protein, known as knockout mice, are protected from developing arthritis or experience significantly less colitis (inflammatory bowel disease) than wild-type mice with normal levels of BSSL. The work has further led to an explanatory model of the mechanism of action, where an important step is that BSSL is secreted from a type of white blood cell (granulocytes) and binds to another (monocytes), which in turn are active in inflammation.

With this background, Lipum has developed a humanized monoclonal antibody, SOL-116, for treatment of chronic inflammatory diseases. The product development initially involved the production of a long series of experimental antibodies that were used and studied in preclinical experiments. With support from the Drug Discovery and Development platform at Science for Life Laboratories operating at the universities of Uppsala, Stockholm, and Lund, work began in 2016 to develop a humanized therapeutic antibody that binds to and inhibits the inflammatory properties of BSSL. Following extensive screening and development work, the drug candidate SOL-116 was selected in the summer of 2019. It was subsequently patented, which is expected to provide intellectual property protection and exclusivity until 2040.

In the fall of 2022, the first part of the clinical phase 1 study with SOL-116 was initiated on healthy volunteer subjects, and in 2024, the last part of the phase 1 study with patients with Rheumatoid arthritis began.