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

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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.

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Thursday, November 4, 2021
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Quartile, Society, University, Kepler-86, American Society of Nephrology, Private Securities Litigation Reform Act, Therapy, Chronic kidney disease, MD, Barratt, Nephrology, Clinical trial, SAN, Security (finance), Vera, University of Leicester, Doctor of Philosophy, Arm, COVID-19, Serum, Standard of care, Immunoglobulin A, FRCP, Patient, Annual general meeting, U.S. Securities and Exchange Commission, GLOBE, Degenerative disease, Abstract, Proteinuria, Death, Randomized controlled trial, B-cell activating factor, B cell, Nasdaq, Poster, Risk, Autoantibody, Pharmaceutical industry, Vaccine
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VERA THERAPEUTICS
Summary
Key Points: 
  • 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.
  • 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.



  • 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.

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