World News: 13:00 GMT Wednesday 12th June 2019. [Selecta Biosciences, Inc. via Globe Newswire via SPi World News]
WATERTOWN, Mass., June 12, 2019 (GLOBE NEWSWIRE) -- (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR™, will present full data from the company’s Phase 2 study of SEL-212 for the treatment of chronic refractory gout at the 2019 European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Madrid, Spain. The poster will be presented on Saturday, June 15, 2019 at 10:30 a.m. CEST (4:30 a.m. EDT).
“We continue to believe SEL-212 has the potential to change the treatment paradigm in chronic refractory gout by fulfilling several unmet needs, including sustained serum uric acid reduction, reduced painful flares and once monthly dosing. These data further position us to execute on our Phase 3 program, which we plan to start later this year,” said Carsten Brunn, CEO of Selecta Biosciences. “With the COMPARE trial now actively enrolling patients, we are excited about the opportunity to demonstrate the superiority of SEL-212 compared to the current FDA-approved uricase therapy.”
SEL-212 is a combination product candidate designed to sustain control of serum uric acid (SUA) levels in patients with chronic refractory gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. SEL-212 consists of pegadricase, our proprietary pegylated uricase, co-administered with ImmTOR™, designed to mitigate the formation of anti-drug antibodies (ADAs). ADAs develop due to unwanted immune responses to biologic medicines, rendering these therapies less potent, which remains an issue across multiple therapeutic modalities and disease states including chronic refractory gout. The data to be presented will show that 66% of evaluable patients (21/32), maintained serum uric acid (SUA) levels of <6mg/dL after five once-monthly treatments of SEL-212 at doses of 0.1 or 0.15 mg/kg of ImmTOR in combination with 0.2 mg/kg of pegadricase. The sustained reduction of SUA correlated with inhibition of ADA formation. Furthermore, reduced tissue urate burden, low gout flare rates and severity of flares were observed in the Phase 2 clinical trial. Only 35% of patients treated with five doses of 0.1-0.15 mg/kg of ImmTOR experienced gout flares after initiation during the first month of treatment with continued reduction of gout flare rates over months two through five. No additional patients reported flares after the second month. SEL-212 has been generally well tolerated at clinically active doses following repeated administrations in the trial.
Globe Newswire: 13:00 GMT Wednesday 12th June 2019
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