Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 ...
IONIS-FB-LRx is an investigational antisense drug being studied for macular degeneration, specifically geographic atrophy secondary to age-related macular degeneration, and for primary IgA nephropathy. It is in Phase 2 clinical development and is not yet approved by the FDA.
IONIS-FB-LRx is being developed by Ionis Pharmaceuticals, Inc., which trades on NASDAQ under the ticker IONS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with geographic atrophy and primary IgA nephropathy.
IONIS-FB-LRx is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in geographic atrophy secondary to age-related macular degeneration and one in primary IgA nephropathy. The drug is investigational and has not received FDA approval.
IONIS-FB-LRx has completed two Phase 2 trials. The GOLDEN STUDY (NCT03815825) enrolled 332 participants with geographic atrophy secondary to age-related macular degeneration. A second trial (NCT04014335) enrolled 23 adults with primary IgA nephropathy. Both trials were randomized, double-blind, and controlled.
IONIS-FB-LRx is an antisense inhibitor of complement factor B, a protein involved in the complement system. By targeting complement factor B, the drug aims to reduce inflammation and tissue damage in conditions like geographic atrophy and IgA nephropathy. Its mechanism is based on antisense technology.