Vera Therapeutics (NASDAQ:VERA) said the U.S. Food and Drug Administration granted accelerated approval to TRUTAKNA, or atacicept-vymj, for adults with primary IgA nephropathy at risk for disease progression.
The company said TRUTAKNA is the first and only BAFF and APRIL inhibitor indicated to reduce proteinuria in adult patients with primary IgA nephropathy, a kidney disease that Vera executives described as driven by B-cell activity. The approval is based on proteinuria reduction, with a confirmatory kidney function endpoint still pending.
“Until now, we have lacked a therapy that can comprehensively address the key upstream drivers of IgAN pathophysiology,” Fordyce said. “TRUTAKNA does exactly that.”
Phase 3 Data Supported Accelerated Approval
Robert Brenner, Vera’s chief medical officer, reviewed data from ORIGIN 3, an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial in adults with IgA nephropathy. Participants were randomized one-to-one to receive TRUTAKNA or placebo.
At the prespecified 36-week interim analysis, the primary endpoint evaluated change in 24-hour urine protein-to-creatinine ratio, or UPCR, compared with placebo in the first 203 participants who received at least one dose of study drug.
Brenner said patients treated with TRUTAKNA achieved a 46% reduction in UPCR from baseline and a statistically significant 42% reduction compared with placebo. He added that the reduction in proteinuria favored TRUTAKNA across prespecified subgroups, including age, sex, race, geographic region, baseline proteinuria, baseline GFR and baseline use of SGLT2 inhibitors.
TRUTAKNA-treated patients also showed a 68% reduction in galactose-deficient IgA1 and resolution of hematuria in 81% of patients who had hematuria at baseline, Brenner said.
On safety, Brenner said TRUTAKNA was generally well-tolerated. The most common adverse events were infections, occurring in 32% of TRUTAKNA-treated patients versus 28% for placebo, and injection site reactions, occurring in 30% versus 5%, respectively. He said most adverse events were mild to moderate and resolved without treatment interruption or discontinuation. No serious, severe or opportunistic infections were observed in TRUTAKNA-treated patients, and no cases of hypogammaglobulinemia were reported.
Commercial Launch Begins With 82 Sales Representatives
Matt Skelton, Vera’s chief commercial officer, said TRUTAKNA is administered through a small 1 mL once-weekly auto-injector that patients can self-administer at home. He said there are approximately 160,000 diagnosed IgA nephropathy patients in the U.S., with a patient population that is roughly 75% commercially insured.
Skelton said Vera is targeting about 6,000 nephrologists who care for most of these patients. The company’s field force of 82 representatives is “fully hired, trained, and in territory,” he said, adding that the team has been conducting disease-state education and building account relationships ahead of approval.
In response to an analyst question, Skelton said more than 80% of the sales force has nephrology experience and 90% has rare disease experience. He said Vera believes the field force is the right size for the opportunity and that representatives are already promoting TRUTAKNA.
Skelton said Vera expects TRUTAKNA to be available in channel in three to four weeks. He said the company does not expect a large immediate bolus of patients, but rather hopes for a “nice, steady demand curve.”
Pricing, Access and Launch Metrics
Vera said TRUTAKNA’s wholesale acquisition cost is $32,700 per carton, with each carton representing four doses, or a 28-day supply. Skelton said that annualizes to $425,000 per year.
The company said eligible commercially insured patients may pay as little as $0 out of pocket through its TRUTAKNA TRU SUPPORT copay assistance program. The support program is intended to help healthcare providers and patients with insurance coverage information, financial assistance options and educational resources.
Skelton said Vera has conducted pre-approval engagements with major payers to support broad and timely access at launch. When asked about formulary positioning, he said the company has done “a lot of homework” with payers and feels good about the launch price.
Asked what launch metrics Vera plans to report, Skelton said patient start forms will be the main early indicator of demand. Fordyce indicated the company would discuss launch metrics in the third quarter.
Next Steps Toward Full Approval
Fordyce said Vera ended the first quarter with approximately $597 million in cash and marketable securities, with access to an additional $425 million through an Oxford facility.
The company is awaiting the confirmatory ORIGIN 3 endpoint based on estimated glomerular filtration rate, or eGFR, which Fordyce said is expected in the third quarter. Brenner said Vera remains on track for that readout, which could support a potential filing for full approval in the fourth quarter.
Brenner also said Vera expects to share more data from PIONEER at the American Society of Nephrology meeting this year, following an initial data disclosure at the European Renal Association meeting.
About Vera Therapeutics (NASDAQ:VERA)
Vera Therapeutics is a clinical-stage biotechnology company focused on developing novel immunotherapies that harness the body’s own regulatory T cells to treat autoimmune and inflammatory diseases. By leveraging a proprietary protein engineering platform, the company designs Treg-selective cytokine variants intended to restore immune balance and provide targeted, disease-modifying effects. Its pipeline comprises multiple preclinical and clinical candidates aimed at indications characterized by chronic inflammation and autoimmunity.
Founded in 2018 and headquartered in Cambridge, Massachusetts, Vera Therapeutics collaborates with leading academic and research institutions to advance its development programs.
-logo-1200x675.png){kind=logo}
