omoprubart (CAN106) / CANbridge Pharma, WuXi AppTec, Privus - LARVOL DELTA

CANbridge Pharmaceuticals Granted Orphan Drug Designation for CAN 106 for the Treatment of Myasthenia Gravis (Businesswire) - "CANbridge Pharmaceuticals...announced that CAN106, a clinical-stage recombinant humanized monoclonal antibody targeting C5, has been granted Orphan Drug Designation by the United States Food and Drug administration (FDA) for the treatment of myasthenia gravis (MG), an autoimmune neuromuscular disease that causes weakness in skeletal muscles."

Orphan drug • Immunology • Myasthenia Gravis

A PHASE 1 SINGLE ASCENDING DOSE STUDY OF CAN106, A LONG-ACTING ANTI-C5 COMPLEMENT MONOCLONAL ANTIBODY IN CLINICAL DEVELOPMENT FOR PNH AND OTHER COMPLEMENT-MEDIATED DISEASES (EHA 2022) - "The dose-exposure relationship was linear, and the 32-day half-life in healthy subjects was similar to that of ravulizumab, which is dosed every 8 weeks in patients, suggesting the potential for an extended dosing interval. CAN106 led to rapid, dose-dependent reductions in free C5 and CH50, and at the two highest doses, achieved complete and sustained complement blockade (>90% inhibition of CH50) for up to 4 weeks. These promising results support further clinical development of CAN106 in PNH and other complement-mediated diseases."

Clinical • P1 data • Anemia • Cardiovascular • Complement-mediated Rare Disorders • Fatigue • Genetic Disorders • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases

Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects (clinicaltrials.gov) - P1; N=31; Completed; Sponsor: CANbridge Life Sciences Ltd.; Active, not recruiting ➔ Completed; Trial completion date: May 2022 ➔ Nov 2021; Trial primary completion date: Mar 2022 ➔ Nov 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date