Vera Therapeutics Presents Phase 2a Data Showing Atacicept Reduces Serum Gd-IgA1 in Patients with IgA Nephropathy at the American Society of Nephrology Kidney Week 2021

Rhea-AI Summary

The Phase 2a JANUS clinical trial for atacicept, conducted by Vera Therapeutics, demonstrated a significant and durable reduction in serum galactose-deficient IgA1 (Gd-IgA1) over 72 weeks in patients with IgA nephropathy (IgAN). The trial revealed that atacicept 75mg lowered serum Gd-IgA1 levels to the lowest risk quartiles, highlighting its potential to improve renal survival. These findings were presented at the American Society of Nephrology Kidney Week 2021. The company anticipates further results from the ongoing Phase 2b ORIGIN trial to clarify the implications of these reductions on renal function.

Positive

• Atacicept demonstrated a durable reduction in serum Gd-IgA1 levels over 72 weeks.
• The 75mg dose of atacicept reduced Gd-IgA1 to the lowest risk quartiles, associated with favorable renal survival.

Negative

• None.

• Phase 2a JANUS clinical trial showed atacicept administered subcutaneously once weekly demonstrated a durable and substantial reduction in serum galactose-deficient IgA1 (Gd-IgA1) in a dose-dependent manner up to 72 weeks
• New quartile-based analysis of JANUS results showed atacicept 75mg reduced serum Gd-IgA1 to the lowest risk quartiles
• Gd-IgA1 plays a central role in IgAN pathogenesis and renal survival has been shown to deteriorate by the quartile of serum Gd-IgA1 level
  

SOUTH SAN FRANCISCO, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a clinical-stage biotechnology company focused on developing treatments for immunological diseases that improve patients’ lives, today presented clinical data for the Company’s lead product candidate, atacicept, from the Phase 2a JANUS clinical trial in patients with IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week 2021 Annual Meeting held virtually November 4-7, 2021.

“Research has shown that Gd-IgA1 plays a significant role in the pathogenesis of IgAN, whereby higher levels of Gd-IgA1 are associated with increased risk of end-stage renal disease or death. These data show the potential of atacicept to reduce Gd-IgA1 levels and therefore potentially mitigate the poor prognosis of patients with IgAN based on Gd-IgA1,” said Celia Lin, MD, Chief Medical Officer at Vera Therapeutics. “We look forward to announcing the results from the ongoing Ph2b ORIGIN trial evaluating atacicept up to 150mg in IgAN patients to help determine how these robust reductions in Gd-IgA1 translate to measures of renal function, including proteinuria and glomerular filtration rate.”

In the Phase 2a randomized, placebo-controlled JANUS trial in 16 IgAN patients, serum galactose-deficient IgA1 (Gd-IgA1) was assessed at baseline, weeks 4, 12, 24, 48, and 72. Results showed that atacicept, administered subcutaneously once weekly, demonstrated a substantial reduction in serum Gd-IgA1 in a dose-dependent manner that was durable through 72 weeks. New analysis of these results initially divided JANUS patients into four equal groups according to the quartiles of serum Gd-IgA1 distribution at baseline. Quartile level was then assessed at each timepoint. This additional analysis showed that atacicept decreased serum Gd-IgA1 levels by up to two quartiles. The largest effect was seen in the atacicept 75mg arm where after 24 weeks all study patients had reductions in serum Gd-IgA1 to the lowest risk quartiles, which is associated with the most favorable renal survival.

Additionally, the serum Gd-IgA1 quartiles determined from a separate cohort of 150 IgAN patients from the University of Leicester were applied to the 16 JANUS patients’ quartile level assessment and confirmed that atacicept 75mg reduced serum Gd-IgA1 to the lowest quartiles at each measured timepoint.

The clinical trial was described in an ePoster presentation (Abstract PO1638) by Jonathan Barratt, PhD, FRCP, The Mayer Professor of Renal Medicine, University of Leicester, UK. The presentation titled, “Atacicept Reduces Serum Gd-IgA1 by Quartiles in IgAN Patients,” was included in the session entitled, Glomerular Disease: Treatment and Outcomes (PO1203-3).

“The Phase 2a JANUS trial was the first study to show substantial Gd-IgA1 reduction with atacicept in IgAN patients,” said Professor Barratt. “This new analysis was conducted to understand the potential effects of atacicept on serum Gd-IgA1 levels in a dedicated study. These results represent the first randomized controlled trial evidence for normalization of Gd-IgA1 with an investigational therapeutic for IgAN patients.”

All ePosters were made available on the meeting platform today Thursday, November 4, 2021 at 10:00 AM PT and will remain available until Friday, January 7, 2022. The poster is also available on the Vera Therapeutics website.

About Vera Therapeutics
Vera Therapeutics is a clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN). For more information, please visit www.veratx.com.

Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the results of Vera’s Phase 2b ORIGIN trial. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans,” “will”, “anticipates,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Vera’s business in general, the impact of the COVID-19 pandemic, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts
Investor Contact:
IR@veratx.com

Media Contact:
Greig Communications, Inc.
Kathy Vincent
(310) 403-8951
kathy@greigcommunications.com

FAQ

What were the results of the Phase 2a JANUS trial for atacicept (VERA)?

The trial showed a significant and durable reduction in serum Gd-IgA1 over 72 weeks, particularly with the 75mg dose reducing levels to the lowest risk quartiles.

What is the significance of Gd-IgA1 in IgA nephropathy?

Gd-IgA1 levels are critical in IgAN pathogenesis, with higher levels linked to an increased risk of end-stage renal disease.

What are the next steps following the JANUS trial results for atacicept?

Vera Therapeutics is looking forward to the results from the ongoing Phase 2b ORIGIN trial to further evaluate atacicept's impact on renal function.