The US Food and Drug Administration (FDA) has granted clearance for Eledon Pharmaceuticals’ Investigational New Drug (IND) application to assess tegoprubart to treat IgA Nephropathy (IgAN).
With the latest development, the company intends to open trial sites in the country as part of its international Phase IIa clinical trial of tegoprubart for IgAN, which is ongoing.
To date, the trial has obtained regulatory clearances in ten countries.
Eledon has plans to further extend the trial to up to two countries, including China.
The multicentre, open-label trial will assess the safety and efficacy of tegoprubart in IgAN patients.
It is enrolling up to 21 subjects into each of the two dose cohorts. These subjects should have confirmed IgAN and a minimum of 0.75 g/24 hours of protein in their urine during screening.
The variation from baseline in urine protein evaluated by the urine protein to creatinine ratio following 24 weeks of treatment is the trial’s primary endpoint.
Dosing will progress till 96 weeks and variation from baseline in the eGFR slope will be evaluated at this time point.
Multiple subjects in the trial have begun receiving treatment with tegoprubart.
A lead compound of the company, tegoprubart is an anti-CD40L antibody.
It has increased affinity for CD40 Ligand, an established biological target, with extensive treatment potential.
Hindering CD40L signalling can enhance proteinuria, lower autoantibodies, cut down immune cell infiltration into the kidneys, and boost survival, preclinical data showed.
A prevalent primary glomerulonephritis ailment, IgAN is characterised by a slow, progressive decline in kidney function. This can cause end-stage renal disease (ESRD), renal transplant, dialysis, and death.
A clinical sign of IgAN is proteinuria or the leakage of blood proteins into the urine.