Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BION-1301 · 3 trials · 3 indications
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
TEAEs and SAEs are assessed throughout each participant's study participation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
| Arm | Type | Description |
|---|---|---|
| BION-1301 | EXPERIMENTAL | 600mg subcutaneous administration every 2 weeks for 104 weeks |
| Placebo | PLACEBO_COMPARATOR | subcutaneous administration every 2 weeks for 104 weeks |
| Part 1: BION-1301 | EXPERIMENTAL | Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Healthy Volunteers receive a single dose of placebo administered by IV infusion. |
| Part 2: BION-1301 | EXPERIMENTAL | Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion in healthy volunteers. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Healthy Volunteers receive placebo by IV infusion. |
| Part 3: BION-1301 | EXPERIMENTAL | Two cohorts of participants with IgAN receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly. |
| Part 4 Retreatment: BION-1301 | EXPERIMENTAL | Eligible participants with IgAN from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly. |
| Name | Type | Description |
|---|---|---|
| BION-1301 | DRUG | BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks. |
| Placebo | DRUG | Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks. |
| BION-1301 Single Dose | DRUG | A single IV infusion infusion of BION-1301 at doses ranging from 10 to 1350 mg, administered once |
| Placebo Single Dose | DRUG | A single IV infusion of placebo |
| BION-1301 Multiple Doses | DRUG | Part 2: Multiple IV infusions of BION 1301 administered every 2 weeks (Q2W) at doses of 50 mg, 150 mg or 450 mg for up to 3 doses. Part 3: Repeated dosing of BION 1301: 450 mg IV Q2W for ≥24 weeks followed by 600 mg SC Q2W, or 600 mg SC Q2W throughout. |
| Placebo Multiple Doses | DRUG | Multiple IV infusions of placebo administered every 2 weeks for up to 3 doses |
Inclusion Criteria: * Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | BION-1301 |
| Vera Therapeutics, Inc. Class A | VERA | 4 | PHASE3 | Atacicept |
| Travere Therapeutics, Inc. | TVTX | 2 | PHASE3 | sparsentan, irbesartan, Dapagliflozin |
| Biogen Inc. | BIIB | 1 | PHASE3 | Felzartamab |
| AstraZeneca PLC | AZN | 2 | PHASE3 | Ravulizumab |
| Vertex Pharmaceuticals Incorporated | VRTX | 2 | PHASE3 | Povetacicept |
| Biohaven Ltd. | BHVN | 1 | PHASE1 | BHV-1400 |
| Jade Biosciences, Inc. | JBIO | 1 | PHASE2 | JADE101 |
| Q32 Bio Inc | QTTB | 1 | PHASE2 | ADX-097 |
BION-1301 is an investigational small molecule being studied for IgA nephropathy (IgAN), a kidney disease. It has also been evaluated in healthy volunteers to assess safety and tolerability. The drug is in clinical development and is not yet approved for any use.
BION-1301 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in IgA nephropathy.
BION-1301 is in Phase 1 clinical development. Early trials in healthy volunteers and adults with IgA nephropathy have been completed, and a Phase 3 study of zigakibart, which is another name for BION-1301, is active but not recruiting participants.
BION-1301 has been studied in two completed Phase 1 trials: NCT03945318, which evaluated safety and tolerability in healthy volunteers and adults with IgA nephropathy, and NCT05508204, an open-label study in Japanese healthy subjects. A Phase 3 trial, NCT05852938, is active but not recruiting.
Yes, BION-1301 is also known as zigakibart. The Phase 3 study NCT05852938, which is active but not recruiting, is titled 'A Study of Zigakibart in Adults With IgA Nephropathy' and is being conducted by Novartis.
BION-1301 is a small molecule, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential to treat IgA nephropathy, a condition characterized by immune complex deposition in the kidneys.