Swedish Orphan Biovitrum (Sobi) and Selecta Biosciences have completed the enrolment of participants for the DISSOLVE I study to assess SEL-212 to treat chronic refractory gout.
SEL-212 is intended to control serum uric acid (SUA) levels in chronic refractory gout patients.
It comprises a therapeutic uricase enzyme (pegadricase) and Selecta’s ImmTOR immune tolerance platform to reduce anti-drug antibodies (ADAs) formation.
The DISSOLVE I study is the first of two clinical trials of a Phase III DISSOLVE clinical programme evaluating the new combination medicine SEL-212.
The double-blind, randomised, placebo-controlled studies in the programme are designed to assess the efficacy and safety of the medicine at two different dose levels of ImmTOR (0.1mg/kg and 0.15mg/kg) and 0.2mg/kg dose of pegadricase.
Sobi stated that each trial will enrol up to 120 participants, where up to 40 participants will be given each dose level and 40 subjects will be treated with placebo.
Sobi president and CEO Guido Oelkers said: “We are pleased that the DISSOLVE programme is progressing and we believe that the less burdensome treatment regimen of the potential new medicine SEL-212 will improve the lives of those suffering from chronic refractory gout.
“We are proud to collaborate with Selecta as we continue to deliver on our shared vision to advance innovative therapies and improve the lives of patients with rare diseases.”
In the DISSOLVE I study, the product’s safety and efficacy will be assessed at six months.
Upon the completion of the six-month study, the trial will continue with a six-month extension to evaluate the safety of SEL-212.
At the six-month time point, the DISSOLVE II study will evaluate the safety and efficacy of the combination product candidate with no extension.
Both studies’ primary goal will be serum uric acid (SUA) control during month six.
Patient-reported outcomes of activity limitation, gout flare incidence, life quality, tophus burden and tender and swollen joint counts will be some of the secondary goals of the studies.
In September, Sobi and the Hellenic Institute for the Study of Sepsis reported positive results from the Phase III SAVE-MORE clinical trial that assessed anakinra plus standard of care (SOC) in moderate-to-severe Covid-19 pneumonia patients.