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APL-2, Pegcetacoplan
Pegcetacoplan is a complement C3 inhibitor that blocks the activation and amplification of the complement cascade by targeting C3.
Pegcetacoplan is a complement C3 inhibitor that blocks the activation and amplification of the complement cascade by targeting C3. Used for Geographic atrophy (age-related macular degeneration), C3 glomerulopathy, Post-transplant thrombotic microangiopathy.
At a glance
| Generic name | APL-2, Pegcetacoplan |
|---|---|
| Sponsor | Apellis Pharmaceuticals, Inc. |
| Drug class | Complement C3 inhibitor |
| Target | Complement C3 |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rare Disease |
| Phase | Phase 3 |
Mechanism of action
APL-2 (pegcetacoplan) is a synthetic cyclic peptide that binds to complement component C3 and prevents its cleavage into C3a and C3b, thereby inhibiting both the classical and alternative complement pathways. By blocking C3 activation, the drug reduces downstream complement-mediated inflammation and tissue damage, which is implicated in several rare and systemic diseases.
Approved indications
- Geographic atrophy (age-related macular degeneration)
- C3 glomerulopathy
- Post-transplant thrombotic microangiopathy
Common side effects
- Injection site reactions
- Meningococcal infection risk
- Nasopharyngitis
- Headache
Key clinical trials
- Safely Quenching Complement in Stroke Survivors (PHASE1)
- APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion (PHASE2)
- A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio (PHASE2)
- Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (PHASE1, PHASE2)
- Study to Evaluate a Pegcetacoplan (Syfovre®) Prefilled Syringe (PHASE3)
- An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD (PHASE3)
- A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) (PHASE2)
- MERIDIAN: A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults With Amyotrophic Lateral Sclerosis (ALS) (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |