Treatment with monthly infusions of SEL-212 was found to significantly reduce serum uric acid levels in adults with chronic refractory gout, according to results from two phase 3 trials.
SEL-212 consists of pegadricase, a proprietary pegylated uricase, coadministered with ImmTOR, a nanoparticle technology with rapamycin designed to generate antigen-specific immune tolerance. The double-blind, placebo-controlled DISSOLVE I (ClinicalTrials.gov Identifier: NCT04513366) and DISSOLVE II (ClinicalTrials.gov Identifier: NCT04596540) trials evaluated the efficacy and safety of 2 different dose levels of SEL-212 in adults 19 years of age and older with chronic refractory gout.
Patients were randomly assigned 1:1:1 to receive SEL-212 0.15mg/kg (high dose), 0.1mg/kg (low dose), or placebo via intravenous (IV) infusion every 28 days for a total of up to 12 infusions. The primary endpoint was serum uric acid (sUA) control during month 6, defined as the percentage of patients who achieve and maintain reduction in sUA less than 6mg/dL for at least 80% of the time during month 6.
In DISSOLVE I, 56% and 48% of patients treated with the high dose and low dose of SEL-212, respectively, achieved sUA control during month 6 vs 4% of patients who received placebo (both P <.0001). Treatment with SEL-212 reduced mean serum urate levels overall by 69% compared with placebo (P <.001).
In DISSOLVE II, 47% and 41% of patients treated with the high dose (P =.0002) and low dose (P =.0015) of SEL-212, respectively, achieved sUA control during month 6 vs 12% of patients on placebo.
Among participants 50 years of age and older, treatment with SEL-212 at the high dose resulted in higher response rates for sUA control. In DISSOLVE I, 65% and 47% of patients treated with the high dose and low dose of SEL-212, respectively, met the primary endpoint vs 5% of patients who received placebo (both P <.0001). In DISSOLVE II, 48% and 45% of patients treated with the high dose (P =.0017) and low dose (P =.0044), respectively, met the primary endpoint vs 14% of patients who received placebo.
Commenting on the findings, Herbert S. B. Baraf, MD, FACP, MACR, Clinical Professor of Medicine, George Washington University School of Medicine and Health Sciences and Principal Investigator of the DISSOLVE program, said: “Based on these data, I believe SEL-212 has the potential to provide an important new uricase-based treatment option for patients with chronic refractory gout. The demonstrated profound lowering of the serum uric acid in the DISSOLVE program should meaningfully impact the quality of the lives of these severely afflicted patients.”
Detailed results from both clinical trials will be presented at an upcoming medical meeting. According to Sobi, regulatory submission in the US is expected in the first half of 2024.
Phase 3 DISSOLVE program of SEL-212 in chronic refractory gout meets primary endpoint. News release. Selecta Biosciences and Sobi. Accessed March 22, 2023. https://www.globenewswire.com/news-release/2023/03/21/2630995/0/en/Phase-3-DISSOLVE-Program-of-SEL-212-in-Chronic-Refractory-Gout-Meets-Primary-Endpoint.html.