Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MOR202 · 2 trials · 4 indications
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
| Arm | Type | Description |
|---|---|---|
| MOR202 5 Doses | EXPERIMENTAL | 5 doses administered on Day 1, 8, 15, 29, and 57 |
| MOR202 2 Doses | EXPERIMENTAL | 2 doses administered on Day 1 and 15 |
| Cohort 1 (newly diagnosed or relapsed participants) | EXPERIMENTAL | Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. |
| Cohort 2 (refractory participants) | EXPERIMENTAL | Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6. |
| Name | Type | Description |
|---|---|---|
| MOR202 | DRUG | MOR202 will be administered as an intravenous infusion |
Inclusion Criteria: * Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form \[ICF\]). * Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h * Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m² (eGFR \>30 and \< 50 ml/min/1.73 m² can be ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Apellis Pharmaceuticals, Inc. | APLS | 2 | PHASE3 | Pegcetacoplan |
MOR202 is an investigational small molecule being studied for the treatment of membranous nephropathy, a type of glomerulonephritis. It is specifically being evaluated in patients who are anti-PLA2R positive. The drug is in clinical development for this condition, with trials conducted in multiple countries.
MOR202 is being developed by Biogen Inc., a biopharmaceutical company listed on NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical trials to assess the safety and efficacy of MOR202 in patients with anti-PLA2R positive membranous nephropathy.
MOR202 is in Phase 2 clinical development. A Phase 2 trial, known as NewPLACE, has been completed to evaluate the efficacy, safety, and pharmacokinetics of MOR202 in patients with anti-PLA2R positive membranous nephropathy. The drug remains investigational and has not been approved by regulatory authorities.
MOR202 has been studied in two completed clinical trials. The first, NCT04145440, was a Phase 1 trial assessing safety and efficacy in anti-PLA2R positive membranous nephropathy with 31 participants. The second, NCT04733040, was a Phase 2 trial called NewPLACE with 24 participants, evaluating efficacy, safety, and pharmacokinetics.
MOR202 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the context of its development for membranous nephropathy. The drug is being studied under this identifier in both Phase 1 and Phase 2 trials.