Positive top-line Phase III results for pegcetacoplan in PNH

10 December 2020

Nordic rare diseases firm Swedish Orphan Biovitrum (STO: SOBI), also known as Sobi, and Apellis Pharmaceuticals (Nasdaq: APLS) today announced positive top-line results at week 48 from the Phase III PEGASUS study, which demonstrated sustained hematological and clinical improvements in patients with paroxysmal nocturnal hemoglobinuria (PNH) who were treated with pegcetacoplan, an investigational, targeted C3 therapy.

The safety profile of pegcetacoplan was consistent with previously reported data and no new safety signals were identified.

In October this year, US biopharma firm Apellis and Sobi inked a strategic deal to accelerate the advancement of systemic pegcetacoplan, whereby Sobi received global co-development and exclusive ex-US commercialization rights for systemic pegcetacoplan. Apellis was paid $250 million upfront, $80 million in development reimbursements over four years, and up to $915 million in regulatory and commercial milestones plus tiered double-digit royalties.

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