A humanised IgG2 monoclonal antibody, sibeprenlimab acts on the B-cell growth factor dubbed APRIL, a critical player in IgAN’s development and progression.
By neutralising APRIL, the drug aims to lower Gd-IgA1 production, a molecule implicated in the disease, potentially preventing further kidney damage and the progression to end-stage kidney disease.
In November last year, Otsuka and its subsidiary Visterra reported favourable outcomes from the Phase II ENVISION clinical trial of the asset for IgAN treatment.
The FDA breakthrough therapy status is given to drugs that could substantially improve treatment over current options based on initial clinical data.
This designation is significant as it enables the FDA to expedite the development and review of sibeprenlimab, which could be crucial for IgAN patients, a condition with high risk of kidney failure.
The existing standard of care for the condition involves renin-angiotensin aldosterone system (RAAS) blockers and blood pressure management, but these measures do not eliminate the risk of kidney failure.
Otsuka executive vice-president and chief medical officer John Kraus said: “We are encouraged by the FDA’s decision to grant breakthrough therapy status for the sibeprenlimab programme.
“This is an important milestone that recognises the potential value that this investigational candidate may have in the future for people living with one of the most common causes of kidney failure.
“Otsuka and Visterra are committed to advancing the Phase III trial for sibeprenlimab and we are deeply appreciative to all of the study participants, their caregivers, and the investigators who have contributed so much to this research.”