Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 959 · 1 trial · 1 indication
The primary analysis for the parallel comparison was hemolysis as measured by LDH at Week 27 by initial treatment received (Period 1).
The primary analysis for the crossover comparison was hemolysis, as measured by the time-adjusted AUEC of LDH, according to treatment assigned during each of the 14-week assessments during Periods 1 and 2.
| Arm | Type | Description |
|---|---|---|
| T (ABP 959) / R (eculizumab) | OTHER | ABP 959 for 52 weeks in Period 1 followed by eculizumab for 26 weeks in Period 2 |
| R (eculizumab) / T (ABP 959) | OTHER | Eculizumab for 52 weeks in Period 1 followed by ABP 959 for 26 weeks in Period 2 |
| Name | Type | Description |
|---|---|---|
| ABP 959 | DRUG | intravenous infusion |
| Eculizumab | DRUG | intravenous infusion |
Inclusion Criteria: * Men and women ≥ 18 years of age. * Historical diagnosis of PNH. * Administration of eculizumab for ≥ 6 months and currently receiving 900 mg of eculizumab. * Hemoglobin ≥ 9.0 g/dL for at least 6 weeks before randomization. * Lactate dehydrogenase \< 1.5 × the upper limit of no...
ABP 959 is being developed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare hematologic disorder. It is a small molecule candidate studied in adults with PNH. Amgen Inc. is developing ABP 959 as a proposed biosimilar to eculizumab, and it is currently in Phase 3 clinical development.
ABP 959 targets complement protein C5. By binding to C5, it is designed to inhibit complement-mediated destruction of red blood cells, which is the underlying mechanism of hemolysis in paroxysmal nocturnal hemoglobinuria. C5 is a validated target in complement-mediated diseases, and eculizumab, the reference product, acts on the same target.
ABP 959 is being developed by Amgen Inc. (ticker: AMGN). Amgen is advancing ABP 959 as a proposed biosimilar to eculizumab for paroxysmal nocturnal hemoglobinuria. The company holds the development program and conducted the Phase 3 trial comparing ABP 959 with eculizumab in adult participants with PNH.
ABP 959 is in Phase 3 clinical development. It has completed one Phase 3 trial, NCT03818607, which evaluated its efficacy and safety compared with eculizumab in adult participants with paroxysmal nocturnal hemoglobinuria. ABP 959 is investigational and has not been approved by the FDA for any indication.
ABP 959 has been studied in one Phase 3 clinical trial, NCT03818607, titled "A Study Evaluating the Efficacy and Safety of ABP 959 Compared With Eculizumab in Adult Participants With PNH." The trial was completed, enrolled 42 participants, and was randomized, double-blind, and controlled. It included sites in the United States, Europe, and Turkey.