Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Vonaprument, ANX007
Vonaprument (ANX007) · 5 trials · 3 indications
Change in GA lesion area as assessed by fundus autofluorescence (FAF)
| 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 |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument (ANX007) |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| 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 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
Vonaprument is an investigational therapy being developed for geographic atrophy, a late stage form of dry age-related macular degeneration, and it has also been studied in open angle glaucoma. It is not yet approved for any indication and remains in clinical development.
Vonaprument targets C1q, a component of the complement system. By binding C1q, the small molecule is designed to inhibit complement activation, a pathway implicated in retinal and optic nerve damage. This mechanism underlies its development in geographic atrophy and open angle glaucoma.
Vonaprument is being developed by Annexon, Inc., which trades on the Nasdaq under the ticker ANNX. The company holds the asset, formerly known as ANX007, and is running its late stage clinical program in geographic atrophy.
Vonaprument is in Phase 3 development. Two Phase 3 trials are underway in geographic atrophy, one active and not recruiting and one not yet recruiting, following a completed Phase 2 study and an earlier Phase 1 study in open angle glaucoma. It is investigational and has not been approved.
Vonaprument has been evaluated across four registered studies. These include the Phase 3 trials NCT06510816 and NCT07807969, the completed Phase 2 trial NCT04656561 in geographic atrophy, and the completed Phase 1 trial NCT04188015 in primary open angle glaucoma. Total enrollment across these studies is 1,534 participants.
Yes. Vonaprument and ANX007 refer to the same investigational compound. The asset was formerly called ANX007 and is also referenced as 2.5mg ANX007, and it is now known as Vonaprument. Annexon, Inc. is the developer behind both names.