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Completion of enrolment in DISSOLVE phase III study evaluating SEL 212 for chronic refractory gout.

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Published:2nd Dec 2021
Swedish Orphan Biovitrum AB (publ) (Sobi) and Selecta Biosciences, Inc. announced the completion of enrolment for DISSOLVE I, the first of two clinical studies of the phase III DISSOLVE development programme of SEL 212 for chronic refractory gout.

SEL212 is a combination of Selecta's ImmTOR™ immune tolerance platform and a therapeutic uricase enzyme (pegadricase).

"The completion of enrolment for the DISSOLVE I study of our phase III DISSOLVE programme is an important step forward in advancing SEL-212 as a potential new, once-monthly treatment option for people suffering from chronic refractory gout," added Carsten Brunn, Ph.D., President and Chief Executive Officer of Selecta. "We are continuing enrolment in the DISSOLVE II study and we remain on track to share topline results from the DISSOLVE clinical program in H2 2022. Our pipeline builds on the learnings from this programme and shows the potential of ImmTOR to overcome unwanted immunogenicity, mitigate detrimental immune responses against enzyme or gene therapies, and provide real change for people with autoimmune diseases."

About the DISSOLVE clinical programme ; The Phase III DISSOLVE clinical programme consists of two double-blind, placebo-controlled studies of SEL 212, titled "A Randomized Double-Blind, Placebo-Controlled Study of SEL 212 in Patients with Gout Refractory to Conventional Therapy," in which SEL 212 will be evaluated at two doses of ImmTOR (0.1 mg/kg and 0.15 mg/kg), and one dose of pegadricase (0.2 mg/kg) in both studies. Each trial will enrol up to 120 patients (with up to 40 patients at each dose level and 40 patients on placebo). In DISSOLVE I, safety and efficacy will be evaluated at six months and will have a six-month extension to evaluate safety. DISSOLVE II will assess safety and efficacy at only the six-month time point, with no extension. The primary endpoint in both studies is serum uric acid (SUA) control during month six, a well-validated measure of disease severity in chronic refractory gout. Secondary endpoints include tender and swollen joint counts, tophus burden, patient reported outcomes of activity limitation and quality of life and gout flare incidence. For more details about the study, visit clinicaltrials.gov (NCT04513366).

SEL 212 is a combination of Selecta's ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).

Sobi has in-licensed SEL 212 from Selecta and is responsible for development, regulatory and commercial activities in all markets outside of China. The phase III programme for SEL 212 is being run by Selecta and funded by Sobi.

Condition: Gout
Type: drug

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