Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ANX007 · 3 trials · 3 indications
Change in GA lesion area as assessed by fundus autofluorescence (FAF)
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| 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: * Diagnosis of geographic atrophy of the macula secondary to age-related macular degeneration as determined by the Investigator and confirmed by the Central Reading Center. * GA lesion must have the following characteristics as determined by the independent Central Reading Cente...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Pozelimab, Cemdisiran |
| Annexon, Inc. | ANNX | 1 | PHASE3 | Vonaprument |
| Belite Bio, Inc. ADR | BLTE | 1 | PHASE3 | Tinlarebant |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| AbbVie, Inc. | ABBV | 1 | PHASE1 | ABBV-6628, SYFOVRE |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR446597, Sham Comparator |
| Ocugen Inc | OCGN | 1 | PHASE1 | OCU410 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | - | Pegcetacoplan |
ANX007 is an investigational small molecule being studied for geographic atrophy and open-angle glaucoma. It is delivered by intravitreal injection. The drug is in Phase 2 clinical development for geographic atrophy and has completed Phase 1 studies in open-angle glaucoma.
ANX007 is being developed by Annexon, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ANNX. The company is conducting clinical trials of ANX007 in geographic atrophy and open-angle glaucoma.
ANX007 is in Phase 2 clinical development for geographic atrophy. A Phase 2 trial of ANX007 in geographic atrophy has been completed. Phase 1 trials in open-angle glaucoma have also been completed. ANX007 is investigational and not approved by the FDA.
ANX007 has completed three clinical trials. NCT04656561 is a Phase 2 study of intravitreal ANX007 in geographic atrophy with 270 participants. NCT03488550 and NCT04188015 are Phase 1 studies in open-angle glaucoma with 9 and 17 participants, respectively.
ANX007 is a small molecule developed by Annexon, Inc. for ophthalmology indications. It is being studied in geographic atrophy and open-angle glaucoma. The drug's mechanism of action is not disclosed in the available clinical trial information.