Merck KGaA eventually abandoned atacicept after trying again and again in multiple autoimmune disorders. Now, Vera Therapeutics has succeeded where the Big Pharma failed.
Vera announced Tuesday after market that atacicept reduced a biomarker linked to improved kidney function in patients with a severe autoimmune disease during a midstage trial, setting up advancement to a phase 3 study.
Atacicept is being tested in the phase 2b ORIGIN trial in 116 patients with immunoglobulin A nephropathy (IgAN), a progressive autoimmune kidney disease that can lead to end-stage kidney disease, requiring transplant or dialysis. The drug was previously tested in multiple autoimmune clinical trials under the guidance of Merck but was unsuccessful. Vera has since taken over with a focus on the IgAN indication, raising $80 million last year to push through midstage development.
The move to search through the German pharma’s dismissed meds seems to have paid off. Vera said that atacicept reduced proteinuria, which is the source of IgAN, in patients at the 24-week time point. That means the therapy achieved statistical significance and met the main goal of the study. Atacicept produced a 31% mean reduction in proteinuria compared to baseline when compared to placebo in the 75/150-mg pooled dose group. The 150-mg dose group had a 33% mean reduction in proteinuria.
The reduction of proteinuria has been linked to slowing of kidney function decline in patients with IgAN, Jonathan Barratt, Ph.D., the Mayer Professor of Renal Medicine at the University of Leicester in the U.K., said in a press release. Barratt said the ORIGIN results are “strongly supportive” of a long-term benefit on kidney function.
Safety was consistent with previous trials of atacicept, with a 1% discontinuation rate due to adverse events. Two percent of patients taking the study drug experienced serious treatment-emergent reactions, while 9% of placebo patients had these reactions.
Vera will now move the med into phase 3 for IgAN in the first half of this year pending discussion with the FDA. The biotech selected the 150-mg dose to advance and will present further data at a future medical meeting.
Atacicept is a recombinant fusion protein designed to selectively inhibit B cells. Vera previously presented a 24-week interim analysis linking atacicept to a dose-dependent drop in serum immunoglobulins and an improvement in the urine protein-creatinine ratio.
Vera will host a conference call with investors Wednesday morning.