Drugs / OMOPRUBART
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05095168 | Feb → Nov 2021 | paroxysmal nocturnal hemoglobinuria | CARE Pharma Shanghai Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05539248 | Mar 2022 → Dec 2024 | paroxysmal nocturnal hemoglobinuria | CARE Pharma Shanghai Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-06-25 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Results CANbridge Reports Positive Preliminary Data in the Omoprubart (CAN106) Phase 1b Trial in Paroxysmal Nocturnal Hemoglobinuria (PNH) in China -Promising Efficacy and Safety with Four-Week Extended Dosing -Data Shows Dose-Dependent Reduction of LDH and Increased Hemoglobin Levels that Demonstrate Clinically Meaningful Hemolysis Inhibition -CANbridge Plans to Advance to Pivotal Trial -CANbridge to Hold Investor Call canbridgepharma.com ↗
CANbridge Pharmaceuticals, Inc. (1228.HK) , a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced positive preliminary results from the ongoing Phase 1b study of omoprubart (CAN106 ) |
| 2022-11-16 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals Announces Orphan Drug Designation Granted to CAN 106 for the Treatment of Myasthenia Gravis canbridgepharma.com ↗
CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, 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. |
| 2022-07-06 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Results CANbridge Forms Scientific Advisory Board to Guide Global Development of CAN106 in Complement-mediated Diseases canbridgepharma.com ↗
CAN106 Phase 1 results showed rapid and potent C5 inhibition, complete and sustained blockade of complement activity |
| 2022-06-10 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Results CANbridge CAN106 Phase 1 Data Presented at the European Hematology Association 2022 Congress canbridgepharma.com ↗
Researchers reported that the long-acting, humanized, anti-C5 monoclonal antibody, CAN106, was safe and well-tolerated with mostly mild or moderate adverse events and no drug-related serious adverse events in this first-in-human single ascending dose study in healthy subjects. |
| 2022-02-07 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Results CANbridge Reports Positive Top-Line CAN106 Phase 1 Data Receives Approval to Treat Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in Phase 1b/2 Trial in China Results Suggest Complete Blockade of Complement Function CAN106 Safe and Well-Tolerated canbridgepharma.com ↗
CAN106 was shown to be safe and well-tolerated with mostly mild or moderate adverse events and no drug-related serious adverse events (SAEs). |
| 2021-07-15 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals CAN106 Investigational New Drug Application Approved in China for the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) canbridgepharma.com ↗ |
| 2020-12-18 | CANbridge (Suzhou) Bio-pharma Co., Ltd. | Regulatory CANbridge Pharmaceuticals CAN106 Investigational New Drug Application Approved in Singapore for the Treatment of Complement Dysregulation Diseases canbridgepharma.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OMOPRUBART | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314854 ↗ |
| Known as | CAN106 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05095168 ↗ |
| Action | Inhibit | “CAN106 is a selective inhibitor of complement activation” NCT05095168 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5314854 ↗ |
| Route | Intravenous | “CAN106 Administered Intravenously (IV) in Healthy Subjects” NCT05095168 ↗ |