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Pharmacists play a significant role in managing gout by educating patients about the disease and ensuring proper medication adherence to urate-lowering therapy.
Sobi announced the submission of a rolling biologics license application (BLA) to the FDA for SEL-212 (Sobi), a novel investigational combination medicine for the treatment of chronic refractory gout (CRG). The BLA submission follows the FDA Fast Track designation of SEL-212 in March 2024.1
The BLA submission was based on results from the phase 3 DISSOLVE 1/2 placebo controlled, randomized pivotal studies that determined the safety and efficacy of 2 dose levels of SEL-212 in adult patients with CRG. The DISSOLVE 1 study met its primary end point with a 56% response rate in patients that received a monthly dose of 0.15 mg/kg of SEL-212. Additionally, the DISSOLVE 2 study also met its primary end point with a response rate of 47% among individuals treated with the same monthly dose.2
"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,” said Lydia Abad-Franch, MD, MBA, head of research, development, and medical affairs, and Chief Medical Officer at Sobi, in a news release.1
Gout is caused by high levels of uric acid in the body that surrounds the joint and other tissues, resulting in flares that cause severe pain. More than 8.3 million individuals in the US have been diagnosed with gout, marking the disease as the most common form of inflammatory arthritis. Chronic refractory gout is a rare, debilitating form of the inflammatory disease, impacting approximately 200,000 US individuals. Individuals with serum urate (SU) levels above 6 mg/dL can experience multiple flares per year and increased nodular masses of uric acids crystals, or tophi.1,3 Additionally, individuals with CRG could also present with symptoms of joint swelling, redness, and intense pain.3
Despite the use of available therapies, the inability to maintain SU levels below 6 mg/dL remains a significant challenge. Around 3% to 10% of US individuals with gout are not sufficiently managed, which is directly or indirectly related to delayed prescribing, inadequate dosage, nonadherence, or intolerance to urate-lowering medications. Even if treated with the maximum dose of urate-lowering medications, a subset of individuals with gout develop the intractable disease, according to the National Kidney Foundation.3
Regardless of treatment strategies, pharmacists play a significant role in managing gout by educating patients of the disease and ensuring proper medication adherence to urate-lowering therapy. Researchers from Goldfien et al conducted a randomized controlled trial that assessed effect of pharmacist’s intervention on achievement of a SU level below 6 mg/dL. Pharmacists included in the study used a preauthorized protocol, which included ordering laboratory tests and initiating and adjusting urate-lowering therapy medications based on SU levels. The results demonstrated that 36% of patients achieved the SU target level after 26 weeks compared to 13% in the control group — confirming pharmacists’ involvement in gout management.4
As an innovative biologic therapy, SEL-212 could provide further treatment for individuals with CRG as it is designed to reduce SU levels and harmful tissue urate deposits which can lead to unbearable gout flares and joint deformity if left untreated.1
SEL-212 contains SEL-037 (Pegadricase; Selecta Biosciences), co-administered with ImmTOR™ (immune tolerance technology), designed to limit the formation of anti-drug antibodies (ADAs). The development of ADAs is a result of unwanted immune responses to biologic medications, diminishing their effectiveness and causing side effects, a persistent challenge across various treatment methods and conditions, including CGR, the study authors noted.1
"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," said Abad-Franch, in a news release.1