BHV-1400 for immunoglobulin A nephropathy
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What is BHV-1400 for immunoglobulin A nephropathy?
BHV-1400 is an experimental therapy under development by Biohaven as a targeted treatment for immunoglobulin A nephropathy (IgAN).
The medication aims to specifically target the underlying cause of IgAN — abnormal antibodies called galactose-deficient IgA1 (Gd-IgA1). For unknown reasons, people with IgAN produce these antibodies, which form immune complexes with other antibodies that accumulate in the kidneys, where they drive inflammation and damage.
BHV-1400 uses Biohaven’s proprietary Targeted Removal of Aberrant Protein degrader technology to bind abnormal Gd-IgA1 antibodies and deliver them to the liver for destruction, helping protect kidney function.
Some other IgAN treatments target the immune system more broadly, lowering levels of healthy antibodies needed to fight infection. By selectively targeting Gd-IgA1, Biohaven believes BHV-1400 can ease the symptoms of IgAN while minimizing side effects associated with broad immune suppression.
In clinical trials for IgAN, researchers are testing BHV-1400 as an under-the-skin (subcutaneous) injection. The therapy is now entering Phase 3 testing.
Therapy snapshot
| Treatment name | BHV-1400 |
| Administration | Subcutaneous injection |
| Clinical testing | Phase 3 |
How will BHV-1400 be administered in IgAN?
In clinical trials involving people with IgAN, patients receive BHV-1400 via subcutaneous injections. Researchers are testing several dosing regimens; a 500 mg dose given twice a month will be used in a planned Phase 3 trial.
The medication is administered via an autoinjector, which, if eventually approved, is expected to provide a patient-friendly, self-administration option.
BHV-1400 in IgAN clinical trials
An ongoing Phase 1 trial, BHV-1400-102 (NCT07054684), is testing BHV-1400 in adults with IgAN. Preliminary results came from 10 participants who received a dose of 500 mg dose once every two weeks for a month. The data showed:
- levels of Gd-IgA1 dropped by more than 60% within two days of the first dose and by 70% after one month, with no significant reductions in other healthy antibodies
- urinary protein levels, an indicator of kidney damage, decreased after a month, while a measure of estimated kidney function increased
- participants reported reductions in fatigue
Investigators are now testing additional dosing regimens of BHV-1400 in the remaining participants and have extended the study period to one year.
A planned Phase 3 trial, BHV-1400-301 (NCT07642050), will recruit approximately 420 adults with IgAN who will receive subcutaneous injections of 500 mg BHV-1400 or a placebo for one year, followed by a one-year extension period in which all participants will receive BHV-1400.
The study’s main goal is to evaluate changes in urinary protein, alongside assessments of overall kidney function and Gd-IgA1 levels.
BHV-1400 side effects
Biohaven has reported that BHV-1400 was well tolerated by participants dosed to date in the Phase 1 trial. Most side effects were mild and resolved on their own, with no serious or severe concerns observed.
More information about the specific side effects of BHV-1400 will become available as clinical trials progress.
IgA Nephropathy News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
