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Also known as ISIS 696844
IONIS-FB-LRx · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| IONIS-FB-LRx | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | Stage 1 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. Stage 2 participants will receive a placebo matching solution, administered subcutaneously every 4 weeks, completing the treatment period at Week 45. |
| Name | Type | Description |
|---|---|---|
| IONIS-FB-LRx | DRUG | Participants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25. Optional 48-week Extension, with drug dosing continuing every 4 weeks. |
| Placebo | DRUG | Placebo matching solution, administered subcutaneously every 4 weeks |
Inclusion Criteria * Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control * Biopsy-proven primary immunoglobulin A (IgA) nephropathy * Hematuria * Proteinuria Exclusion Criteria * Clinically significant ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 7 | PHASE3 | Surabgene Lomparvovec, RGX-314, ABBV-6628 |
| Ocular Therapeutix Inc | OCUL | 3 | PHASE3 | OTX-TKI |
| 4D Molecular Therapeutics, Inc. | FDMT | 3 | PHASE3 | 4D-150 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE3 | Aflibercept, Pozelimab, Cemdisiran |
| Novartis AG Sponsored ADR | NVS | 5 | PHASE2 | Iptacopan, GT005, FWY003 |
| EyePoint, Inc. | EYPT | 2 | PHASE3 | EYP-1901 |
| Kodiak Sciences, Inc. | KOD | 1 | PHASE3 | Tarcocimab tedromer, Tabirafusp tedromer |
| Hoffmann-La Roche | RHHBY | 10 | PHASE3 | Ranibizumab, Susvimo, RO7965032, OpRegen, Faricimab |
| Outlook Therapeutics, Inc. | OTLK | 1 | PHASE3 | ONS-5010 |
| Adverum Biotechnologies, Inc. | ADVM | 4 | PHASE3 | Ixo-vec, ADVM-022 |
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-3007 |
| Amgen Inc. | AMGN | 1 | PHASE3 | ABP 938, Aflibercept |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-81201887 |
| Ocugen Inc | OCGN | 1 | PHASE3 | OCU410 |
| Alcon AG | ALC | 1 | PHASE1 | AR-14034 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE1 | SAR402663 |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-033 |
| Bayer | BAYRY | 2 | - | Aflibercept |
IONIS-FB-LRx is an investigational antisense drug being studied for primary IgA nephropathy and for geographic atrophy secondary to age-related macular degeneration. It is in Phase 2 clinical development and has not been approved by the FDA.
IONIS-FB-LRx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IONS.
IONIS-FB-LRx is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any use.
IONIS-FB-LRx has been studied in two completed Phase 2 trials. The GOLDEN STUDY (NCT03815825) evaluated the drug in 332 participants with geographic atrophy secondary to age-related macular degeneration. A second trial (NCT04014335) evaluated it in 23 adults with primary IgA nephropathy.