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First patient randomised phase 3 DISSOLVE clinical programme of SEL-212

Swedish Orphan Biovitrum AB (publ) (Sobi) and Selecta Biosciences, Inc. announced the commencement of the phase 3 clinical programme of SEL-212 for chronic refractory gout, with the randomisation of the first patient in the study.

“We are pleased to have commenced the phase 3 DISSOLVE programme evaluating SEL-212 in two phase 3 double-blind, placebo-controlled studies,” said Carsten Brunn, Ph.D., President and CEO of Selecta. “SEL-212 serves as an important validation of Selecta’s ImmTOR platform, and we are proud to have advanced it into late-stage clinical studies. In partnership with Sobi, we look forward to enrolling patients in the studies and continuing to evaluate SEL-212 as a new, once monthly treatment option for patients with chronic refractory gout.”

Guido Oelkers, President and CEO of Sobi, added, “SEL-212 has the potential to significantly improve outcomes for patients with chronic refractory gout, and we are proud to have taken the next step towards making this therapy accessible to patients unable to maintain treatment with the currently available options.”

Sobi has in-licensed SEL-212 from Selecta and will be responsible for development, regulatory and commercial activities in all markets outside of China. The phase 3 programme for SEL-212 is being run by Selecta and funded by Sobi. Topline data from the phase 3 clinical programme is expected in the second half of 2022. Biologics license application (BLA) filing to the US FDA for SEL-212 is expected in Q1, 2023.

On commencement of the phase 3 programme Sobi will pay a milestone of 5 MUSD to Selecta. PR NewsWire

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