Sobi begins rolling BLA for SEL-212 to treat chronic refractory gout

STOCKHOLM, July 2, 2024 -- Sobi® has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for their novel therapeutic, SEL-212. This application is founded on the pivotal findings from the DISSOLVE I and II studies. SEL-212 is being developed to treat chronic refractory gout, a severe condition marked by the continuous and painful accumulation of urate crystals in the joints.

This step marks a considerable advancement following the FDA's Fast Track designation of SEL-212 in March 2024, highlighting the pressing need for new treatments for chronic refractory gout. The FDA's Fast Track program aims to speed up the development and review process for medicines addressing serious conditions with unmet medical needs.

"We are very pleased to initiate the rolling submission of the BLA for SEL-212, bringing Sobi one step closer to providing a potential new, effective treatment option for patients with chronic refractory gout," commented Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs, and Chief Medical Officer at Sobi. "The Fast Track designation confirms the previously released SEL-212 phase 3 clinical data, highlighting the significant need for innovative therapies in this space and reinforcing our commitment to transforming the lives of patients with rare diseases."

SEL-212 is a pioneering investigational combination drug aimed at lowering serum urate (SU) levels in individuals with chronic refractory gout. This reduction in SU levels may decrease detrimental urate deposits in tissues, which can otherwise lead to severe gout flares and joint deformities if untreated. Sobi acquired the license for SEL-212 from Selecta Biosciences, now known as Cartesian Therapeutics, in June 2020, assuming responsibility for its development, regulatory processes, and commercialization across global markets, excluding China.

SEL-212 consists of pegadricase, Selecta's unique pegylated uricase, administered alongside ImmTOR™. ImmTOR™ is designed to reduce the formation of anti-drug antibodies (ADAs), which are elicited by immune responses to biological therapies, diminishing their efficacy and tolerability. This remains a challenge across various therapeutic fields, including chronic refractory gout.

Chronic refractory gout is a form of inflammatory arthritis affecting over 8.3 million people in the United States alone. This condition arises from high uric acid levels in the body, leading to deposits around the joints and other tissues, which can cause excruciating pain during gout flares. Approximately 200,000 individuals in the U.S. experience chronic refractory gout, which does not respond to standard treatments. These patients often have SU levels exceeding 6 mg/dL, suffer from multiple gout flares annually, and may develop tophi—nodular masses of uric acid crystals. Elevated SU levels are also linked to cardiovascular, metabolic, renal, and joint diseases.

Cartesian Therapeutics, previously Selecta Biosciences, is at the forefront of developing mRNA cell therapies for autoimmune diseases. Their leading candidate, Descartes-08, is an mRNA CAR-T therapy currently in phase 2b clinical trials for generalized myasthenia gravis, with further phase 2 studies planned for systemic lupus erythematosus and other autoimmune conditions. Cartesian's pipeline also includes Descartes-15, an advanced autologous anti-BCMA mRNA CAR-T therapy.

Sobi® is an international biopharmaceutical firm focused on transforming the lives of individuals with rare and severe diseases through innovative medicines in haematology, immunology, and specialty care. With approximately 1,800 employees globally, Sobi reported revenues of SEK 22.1 billion in 2023. Sobi® shares are traded on Nasdaq Stockholm.

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