At the helm is Dr. Marshall Fordyce, Founder and CEO of Vera, whose unique path from infectious disease physician to biotech entrepreneur has shaped the company’s patient- and physician-centred mission.
Vera is advancing innovative therapies for serious autoimmune diseases, starting with IgA nephropathy (IgAN), a chronic autoimmune kidney disease that often leads to kidney failure. IgAN is the most common cause of primary glomerular disease globally and a major contributor to end-stage kidney disease (ESKD).
Vera Therapeutics
Each year, an estimated 2.5 per 100,000 people are newly diagnosed with IgAN worldwide, and about up to 50% of patients progress to kidney failure within 20 years of diagnosis.
Typically presenting in patients in their 20s or 30s, IgAN is a chronic, progressive condition that can significantly affect quality of life for decades.
This disease represents a significant component of the broader chronic kidney disease (CKD) burden, which impacts over 850 million people worldwide — approximately 1 in 10 individuals.
Historically, treatments for IgAN have relied on non-specific immunosuppressants and corticosteroids, both of which carry substantial side effects. Recent scientific advances have shed light on B-cell pathways and autoantibody generation, paving the way for more targeted strategies that inhibit BAFF (B cell-activating factor) and APRIL (a proliferation-inducing ligand).
Achieving meaningful progress in this complex therapeutic area has required vision, adaptability and deep respect for the scientific process — qualities that continue to guide Vera’s work.
Xtalks Clinical Edge: Issue 5 — Vera Therapeutics on Redefining Autoimmune Kidney Disease Treatment
Xtalks Clinical Edge™ is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.
From Bedside to Boardroom: A Physician’s Pursuit of Better Tools
Dr. Fordyce’s journey began in medicine with aspirations to serve patients directly, especially those affected by HIV/AIDS and other global health challenges.
His training at NYU Bellevue and Columbia Presbyterian placed him at the frontlines of care in high-stakes environments, shaping a deep understanding of unmet clinical needs.
But over time, it became clear that direct patient care, while meaningful, wasn’t the only path to impact. “Most physicians hit a juncture where they know we can serve patients better than what we’re currently doing,” he said.
This realization led him to Gilead Sciences, where he contributed to several antiviral programs, including those targeting HIV and hepatitis C — therapeutic areas that ultimately redefined what was possible in antiviral treatment. The experience gave him a front-row seat to how multidisciplinary teams bring a drug from concept to clinic.
As he grew into a leadership role, Dr. Fordyce began to imagine a future where he could shape not only the science, but the strategy and culture of a new kind of company.
That opportunity came in 2016 when he founded what would become Vera Therapeutics. The initial concept focused on non-CRISPR gene editing, backed by early support from Kleiner Perkins and GV (formerly Google Ventures). But science, not sentiment, led the company to pivot when the platform proved unready for translation.
That early decision to follow the data — even when it meant letting go of the original vision — set the tone for Vera’s operating philosophy moving forward.
A Strategic Shift Toward Autoimmune Diseases
In 2019, Vera redirected its focus to autoimmune disease, guided by a simple but powerful observation: roughly 1 in 10 people worldwide live with an autoimmune condition, yet many are treated with non-specific, decades-old therapies. Corticosteroids and broad-spectrum immunosuppressants remain the standard of care for diseases like lupus, even as our understanding of B-cell biology has advanced significantly.
This led the Vera team to revisit the mechanism of BAFF inhibition, already a validated target in lupus. However, Vera saw an opportunity to take it one step further.
“BAFF is one of two key signals for B-cell survival. The other is APRIL,” Fordyce explained. Together, these cytokines help drive the production of autoantibodies, which are central to many autoimmune diseases, including IgAN.
Their search for a dual BAFF/APRIL inhibitor led them to their lead candidate, a fusion protein developed initially in the early 2000s but never fully commercialized. While previous trials in complex diseases like lupus and rheumatoid arthritis had mixed results, Vera saw potential in a more narrowly defined population — patients with biopsy-confirmed IgAN at high risk of progression.
Science-Driven Strategy: Why IgAN Was the Right Fit
IgAN, also known as Berger’s disease, is a progressive autoimmune condition that affects the kidneys’ filtering units (glomeruli), often leading to ESKD.
Unlike other autoimmune diseases, IgAN can be diagnosed and monitored with well-established biomarkers like proteinuria and estimated glomerular filtration rate (eGFR). That clarity made it an ideal setting for Vera Therapeutics to test its lead drug candidate, which modulates B-cell activity by blocking both BAFF and APRIL.
Vera’s Phase IIb trial was designed with rigor—a multinational, randomized, placebo-controlled, dose-ranging study. “We ran a pharma-like Phase IIb trial,” said Dr. Fordyce. “That gave us a strong sense of what is the right dose and the right patient population.”
The results confirmed the hypothesis. The lead candidate significantly slowed the decline of kidney function, with some patients maintaining near-normal eGFR two years into treatment. Just as important, the safety profile closely mirrored that of placebo, even during the COVID-19 pandemic.
“We showed that we could modulate the immune system without suppressing it to a dangerous degree,” he said. Patients receiving the lead candidate had no increased risk of infection, including COVID-related complications.
With a strong Phase II foundation, Vera rapidly moved into Phase III. The trial met the primary endpoint, and the company plans to file a BLA by the end of 2025 and if approved, aims to launch the product commercially in 2026.
Centering Patients — and Physicians — Every Step of the Way
At Vera, patient centricity is more than a value statement — it’s embedded into the company’s internal culture and external operations.
“We bring a patient in to speak to the full company at least once a quarter,” Dr. Fordyce said. These sessions help ensure that every team member, whether on the clinical or finance side, understands the human impact of their work.
But Dr. Fordyce is equally passionate about supporting physicians. “It’s a terribly uncomfortable position to not be able to offer a patient something that helps,” he said. By developing their lead candidate, Vera aims to give nephrologists a new tool — one with the potential to halt or significantly delay the progression of IgAN.
This dual focus on patients and physicians is already influencing Vera’s commercialization strategy. The team is actively preparing educational campaigns to ensure that nephrologists understand the potential clinical value and safety profile of their lead candidate.
Dr. Fordyce notes that while the data are compelling, they don’t “speak for themselves.” They must be interpreted, communicated and contextualized across stakeholder groups — from regulators and payers to clinicians and caregivers.
Expanding the Pipeline: A Platform, Not Just a Product
While IgAN remains the lead indication, Vera is already expanding its clinical program to adjacent renal diseases, including membranous nephropathy and select forms of focal segmental glomerulosclerosis (FSGS). The company now has seven active clinical trials — up from just two a year and a half ago —signaling its ambition to become a long-term leader in autoimmune nephrology.
“The results we’ve seen in IgAN gave us the confidence to move into adjacent diseases with similar B-cell-driven mechanisms.”
— Dr. Fordyce
This growth is also reflected internally, with Vera scaling its operations, commercial infrastructure and global partnerships. A recent meeting brought together global nephrology leaders to align on the next phase of Vera’s strategy, underscoring its intent to lead innovation in this space.
Navigating a Complex Market — and Building for the Long Term
Despite scientific momentum, Dr. Fordyce acknowledges the challenges of operating in a complex macro environment.
Market volatility, reduced NIH funding and geopolitical tensions have all put pressure on biotech innovation.
“When there’s peace and prosperity, science flourishes,” he said. “When those conditions are strained, so is progress.”
That said, Vera’s early decision to go public in 2021 positioned it well. Access to capital, even in a rough market, remains critical for late-stage clinical development and commercialization. Dr. Fordyce views the public markets not just as a funding source, but also as a platform for transparency, governance and long-term growth.
As for the company’s ultimate ambition? It’s not just about launching a successful drug. “I want Vera to become the biotech company of the future,” he said. “We’re earning that opportunity every day — by trusting the science, serving patients and building a business that can endure.”
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