Vera Therapeutics this week announced successful results in its...

Vera Therapeutics this week announced successful results in its 431 patient Phase 3 trial of atacicept in IgA Nephropathy (igAN), a chronic autoimmune condition that can lead to kidney failure.

The primary endpoint in the trial was reduction on proteinuria at 36 weeks. A 46% decline from baseline was seen and a 42% reduction compared to placebo (p<0.0001).

The Company claimed that this was the “deepest reduction” of proteinuria in a late-stage study in IgAN patients to date.

Vera shares climbed by nearly 60% on the news.

Vera plans to submit a BLA for accelerated approval in 4Q 2025 and is hoping for approval in 2026. In the meantime, the trial will continue, with two-year results expected in 2027.

It is estimated that there are ~ 160,000 people with IgAN in the US and Vera is currently targeting the estimated 90,000 of these patients who are considered to be at high risk.


To date, four treatments have been approved by the FDA for igAN and all were granted accelerated approval. None to date has been shown to reduce the rate of eGFR decline to a level that minimizes the lifetime risk of kidney failure, and thus are not disease-modifying treatments in IgAN.

TARPEYO (budesonide) was developed by Calliditas Therapeutics and was initially FDA approved in 2021. Calliditas was acquired by Japanese Asahi Kasei last year for US$1bn +.

FILSPARI (sparsentan), developed by Travere Therapeutics), was approved in 2023.

FABHALTA (iptacopan), was developed by Novartis and approved last August. It is also approved in two other indications.

Vanrafia (atrasentan) came to Novartis by way of its acquisition of Chinook Therapeutics for US$3.2bn in mid-2023. It was approved in April this year.

Novartis also has a third igAN candidate under development. Zigakibart is currently in Phase 3, with results expected next year. Novartis is hoping to submit a BLA for zigakibart in IgAN in 2027.


There are further igAN drug candidates in late-stage trials or awaiting regulatory approval.

In March this year, Otsuka Pharmaceuticals filed a BLA for its candidate in igAN, sibeprenlimab, which it acquired in 2018.

Roche/Ionis commenced a Phase 3 trial of IONIS-FB-LRx in igAN in 2023. Following a successful 10 patient Phase 2 study, Roche paid Ionis an upfront of US$55 m in 2022 to license the asset in igAN. Roche is responsible for all costs moving the drug forward.

AstraZeneca commenced a Phase 3 trial of its igAN candidate, ULTOMIRIS (ravulizumab) early last year and hopes to complete the trial by February next year.

Vertex joined the fray in April last year when it acquired Alpine Immune Sciences for US$4.9bn. Vertex competed with four other companies to acquire Alpine following its presentation of Phase 1b/2a data for its igAN candidate, povetacicept, in November 2023. Povetacicept entered a Phase 3 trial late last year. Vertex is hoping for accelerated approval from the FDA by the end of 2027.

Alexion commenced a Phase 3 trial of ravulizumab in igAN in March last year which it expects to complete early next year.

Biogen also acquired an igAN asset (felzartamab) in May last year from Human Immunology Biosciences, (HI-Bio). Biogen purchased HI-Bio for US$1.15 bn, along with up to US$650 m in potential milestone payments. There are plans to commence a Phase 3 study of felzartamab in igAN later this year.

There are currently over 30 igAN therapies in the pipeline, including another being developed by Takeda (mezagitimab).


So now to ADPKD.

This is also a chronic condition that can lead to kidney failure with the difference being that ADPKD has a clear genetic cause.

ADPKD is more prevalent than igAN. An estimated 500,000 people in the US have the condition; those with ADPKD caused by a fault in the PKD1 gene, which is what PYC is targeting, account for approx. 80%. Nevertheless, ADPKD has been accepted by the FDA as an orphan indication.

Like igAN, ADPKD is potentially eligible for an accelerated approval regulatory pathway, as seen recently with Regulus Therapeutics.

There is currently just one FDA approved drug for ADPKD, tolvaptan, which only slows cyst growth and prolongs the time to kidney failure but has side effects that include frequent urination and possible liver damage.

As seen using igAN as an example, there is considerable competitive interest by large pharma in kidney assets, including by Novartis, Roche, Astra Zeneca, Vertex, Alexion, Biogen, Takeda and Otsuka. Other large pharma with interest in nephrology include Amgen and GSK and Pfizer has shown recent interest in genetic kidney diseases.