Sobi announced the initiation of a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for SEL-212. The submission is based on the results of the DISSOLVE I and II pivotal studies. SEL-212 is an innovative biologic therapy in development for the treatment of chronic refractory gout, a debilitating condition characterised by the persistent and painful build of urate crystals in the joints.

This significant milestone follows the FDA's Fast Track designation of SEL-212 in March 2024, underscoring the urgent need for new treatment options for patients with chronic refractory gout. The FDA's Fast Track program is intended to facilitate the development and expedite the review of medicines that treat serious conditions and fill an unmet medical need. Sobi is a novel investigational combination medicine designed to reduce serum urate (SU) levels in people with chronic refractory g out, potentially reducing harmful tissue urate deposits which can lead to gout flares and joint deformity when left untreated.

Sobi licensed SEL-212 from Selecta Biosciences (now Cartesian Therapeutics) in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. SEL-212 is a novel investigational combination Medicine designed to reduce serum urate ("SU") levels in people with chronic ref refractory gout, potentially reducing harmful tissue Urate deposits which when left untreated can lead to debilitating gout flares and joint deformITY. SEL-212 consists of pegadricase, Selecta's proprietary pegylated uricase, co-administered with ImmTOR??, designed to mitigate the formation of anti-drug antibodies (ADAs).

Gout is the most common form of inflammatory arthritis with more than 8.3 million people in the United States having been diagnosed with gout, which is caused by high levels of uric acid in the body that accumulate around the joints and other tissues and can result in flares that cause intense pain. Approximately 200,000 people in the United States suffer from chronic gout refractory to conventional medicines, a painful and debilitating condition in people with SU levels above 6 mg/dL and therefore have several flares per year and can develop nodular masses of uric acid crystals known as tophi. Elevated SU levels have been associated with diseases of the heart, vascular system, metabolism, kidney and joints.