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1 products found

pp-193

Solution for infusion

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Paroxysmal nocturnal haemoglobinuria (PNH); multiple complement-mediated disorders Clinical stage: Phase 2 — ongoing in PNH and additional complement diseases Modality: Biological (first-in-class complement factor B inhibitor — monoclonal antibody) Mechanism / Target: First-in-class inhibitor of complement factor B (fB); blocks the alternative complement pathway at an early amplification step without disrupting the classical or lectin pathways; prevents haemolysis and thrombotic complications in PNH Route / form: IV infusion / subcutaneous injection Differentiation: First-in-class complement factor B inhibitor; highly selective for the alternative pathway (preserves immune defence against pathogens dependent on classical/lectin pathways); broad applicability across complement-mediated diseases;
Manufacturer #39333
US clinical-stage biotech developing Rx monoclonal antibody biologics that selectively block the complement alternative pathway for rare and non-rare diseases. Lead candidates have completed Phase I and are progressing through Phase II studies in hematologic and ophthalmic complement-mediated conditions. Actively pursuing partnerships for further clinical advancement.

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