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Also known as Vonaprument, ANX007
Vonaprument (ANX007) · 5 trials · 3 indications
GA lesion area was assessed by fundus autofluorescence (FAF) imaging, by an independent central reading center for GA lesion area. A linear mixed effect (LME) model was used to analyze the rate of change from baseline to Month 12 GA lesion area (mm2) for all groups. The model included fixed effects of treatment, time point, treatment by time point interaction, baseline GA lesion area, baseline GA lesion area by timepoint interaction, and baseline lesion multifocality. A random intercept for participant ID and a random slope for timepoint are included to account for repeated measurements for participants. The GA lesion area was analyzed as reported (that is, not transformed).
| Arm | Type | Description |
|---|---|---|
| Vonaprument | EXPERIMENTAL | Participants will receive vonaprument IVT injections every month for 24 months. |
| Sham Group | SHAM_COMPARATOR | Participants will receive Sham IVT injections every month during the 24-month treatment period. |
| ANX007 Group 1 | EXPERIMENTAL | ANX007 administered every month |
| ANX007 Group 2 | EXPERIMENTAL | ANX007 administered every other month |
| Sham Group 3 | SHAM_COMPARATOR | Sham injection administered every month |
| Sham Group 4 | SHAM_COMPARATOR | Sham injection administered every other month |
| 2.5mg ANX007 | EXPERIMENTAL | 1 in every 3 subjects will be randomized to 2.5mg dose of ANX007. |
| 5.0mg ANX007 | EXPERIMENTAL | 1 in every 3 subjects will be randomized to 5.0mg dose of ANX007. |
| Sham Procedure | SHAM_COMPARATOR | 1 in every 3 subjects will have a sham procedure performed instead of receiving ANX007. |
| ANX007-GLA-01 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Vonaprument | DRUG | Form: solution for injection; Route of Administration: IVT injection |
| Sham Administration | OTHER | Form and Route of Administration: to mimic IVT injection (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to stimulate the pressure of an injection). |
| ANX007 | DRUG | Form: solution for injection; Route of Administration: IVT |
| Sham comparator | OTHER | Form and Route of Administration: pressure to mimic IVT injection |
| 2.5mg ANX007 | BIOLOGICAL | A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29. |
| 5.0mg ANX007 | BIOLOGICAL | A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29. |
| Sham Procedure | OTHER | The sham injection is preformed by applying pressure to the eye at the location of a typical IVT injection using the blunt end of a syringe without a needle. |
Inclusion Criteria: * Participants with a diagnosis of dry AMD with GA who completed the Phase 3 ARCHER II study (NCT06510816) and who had not permanently ceased receiving the assigned masked treatment (IVT or Sham administration) at/before the ARCHER II Month 24 Visit. Exclusion Criteria: * Any ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Annexon, Inc. | ANNX | 2 | PHASE3 | Vonaprument (ANX007) |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597 |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Genentech, Inc. | RHHBY | 1 | PHASE2 | OpRegen |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
Vonaprument is an investigational small molecule being developed for geographic atrophy, a form of dry age-related macular degeneration, and for open angle glaucoma. It is administered by intravitreal injection into the eye. It is not yet approved and remains in clinical development.
Vonaprument targets C1q, a component of the complement system. By binding C1q, the drug is designed to modulate complement-mediated activity. This mechanism is being studied in ophthalmology indications including geographic atrophy and open angle glaucoma.
Vonaprument is being developed by Annexon, Inc., which trades on the Nasdaq under the ticker ANNX. The company is running Phase 3 clinical programs for the asset in geographic atrophy.
Vonaprument is in Phase 3 clinical development. Two Phase 3 trials are registered, one active and not recruiting and one not yet recruiting, along with a completed Phase 2 study and a completed Phase 1 study. It is investigational and has not been approved.
Vonaprument has been studied in NCT07807969, an open-label Phase 3 long-term safety extension in geographic atrophy, NCT06510816, a Phase 3 efficacy and safety trial in geographic atrophy, NCT04656561, a completed Phase 2 geographic atrophy study, and NCT04188015, a completed Phase 1 open angle glaucoma study.
Yes. Vonaprument is the current name for the compound formerly known as ANX007. References to ANX007, 2.5mg ANX007, or Vonaprument all refer to the same investigational small molecule developed by Annexon, Inc.