Santhera Pharmaceuticals Holding AG

Santhera Pharmaceuticals noted topline results from a two-part Phase 1 clinical study of AGAMREE® conducted by its North American licensing partner, Catalyst Pharmaceuticals. The study suggests AGAMREE® delivers glucocorticoid and anti-inflammatory activity while avoiding significant immunosuppressive effects, supporting its potential use across a broad range of chronic inflammatory rare diseases. In healthy adult volunteers, both AGAMREE® and deflazacort showed expected glucocorticoid receptor activity and comparable cortisol suppression at clinical doses, but AGAMREE® had less pronounced immunosuppressive biomarker effects. Clinically relevant immunosuppressive effects were observed only at the highest dose level, above currently approved dosing for Duchenne muscular dystrophy. Under the 2023 license agreement, Catalyst holds North American commercialization rights for all indications, while Santhera retains a right of first negotiation for new indications outside North America and is eligible for sales-based milestones and royalties.