Vera Therapeutics Reports Positive Phase 2 Interim Data Showing MAU868 Has Antiviral BK Activity In Renal Transplant Patients

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  • MAU868, the primary class I monoclonal antibody, It was nicely tolerated in kidney transplant recipients with BK viremia

  • The information had been introduced as an oral delayed interruption on the American Congress of Organ Transplantation

  • BK virus is a significant reason for implant loss and related morbidity; Presently, there are not any authorized remedies

Brisbane, CA, June 4, 2022 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc., introduced right now. (Nasdaq: VERA), a late-stage biotechnology firm targeted on creating and advertising and marketing transformative therapies for sufferers with severe immune illnesses. Knowledge from a part II trial of MAU868 versus placebo for BK Virus (BKV) therapy in kidney transplant sufferers confirmed that MAU868 was nicely tolerated and confirmed important anti-BK virus exercise in BK virus-infected kidney transplant recipients. This knowledge was delivered right now within the type of a current oral presentation by Daniel C. Brennan, MD, Medical Director, Complete Transplant Middle, Professor of Medication, Johns Hopkins College Faculty of Medication, and research investigator, on the American Transplantation Convention (ATC) 2022 in Boston, Massachusetts.

BKV an infection represents important morbidity and mortality components in renal transplant recipients. Sufferers are normally given medicine to suppress their immune system, which will increase the chance of BKV nephropathy, which is intently associated to allograft loss and organ rejection. Our present immunosuppressive protocols in kidney transplantation can result in BKV reactivation. Stanley C. Jordan, MD, FASN, FAST, director of nephrology and immunology, Cedars-Sinai Medical Middle, professor of pediatrics and medication on the David Geffen Faculty of Medication on the College of California, Los Angeles, and lead researcher on the research. “These interim outcomes from a part II scientific trial demonstrated that MAU868 was nicely tolerated and demonstrated important anti-BK antiviral exercise in kidney transplant recipients contaminated with BK virus. These knowledge assist the additional growth of MAU868 as a therapy for BK virus.”

“MAU868 is a first-line focused remedy particularly designed to neutralize BKV. Knowledge introduced at ATC demonstrated that MAU868 has a clinically significant virological impact in kidney transplant sufferers contaminated with BK virus,” mentioned Celia Lin, chief medical officer of Vera Therapeutics. “These outcomes reveal the transformative potential of MAU868, which can forestall the devastating penalties of BKV. We’re working laborious to develop our scientific program for MAU868 in order that we will present this necessary potential therapy choice to kidney transplant sufferers who at the moment do not need efficient therapy choices.”

Particulars of the final oral presentation are as follows:

Title:

A randomized research of MAU868 versus placebo for therapy of BK virus in kidney transplant recipients

Presenter:

Daniel C. Brennan, MD

Abstract quantity:

7056

Show quantity:

9004

This part II, randomized, double-blind, placebo-controlled scientific trial is evaluating the security and efficacy of MAU868 in sufferers who obtained a kidney transplant inside 1 12 months of enrollment and, inside 10 days of enrollment, had viral BK. Sufferers obtained MAU868 or placebo intravenously (IV) each 28 days for 12 weeks, with a follow-up of 24 weeks. On this scientific trial, 20 sufferers obtained MAU868 and eight sufferers obtained placebo; All sufferers accomplished 12 weeks of therapy. This interim evaluation reported outcomes at 12 weeks for 2 teams: MAU868 1350 mg IV x4, and MAU868 6750 mg IV adopted by MAU868 1350 mg IV x3 dosing. The first finish level was security and tolerability; Antiviral exercise was evaluated in secondary and submit hoc analyses.

The outcomes confirmed that the antiviral impact was increased within the MAU868 group than within the placebo group (see desk). Moreover, MAU868 was nicely tolerated, with comparable frequency of antagonistic occasions and severe antagonistic occasions between teams.

Desk: Antiviral Impact of MAU868 vs. Placebo at Week 12

MAU868
(n = 20)

placebo
(n = 8)

P-
the worth

Proportion of sufferers with a predetermined discount of BK plasma viral load – n (%)

– by ≥1 file

11 (55%)

1 (13%)

0.040

– to < minimal quantitative estimation (LLOQ)

4 (20%)

0

0.172

– from <104 DNA transcripts/ml

15 (75%)

3 (38%)

0.061

Log lower in BK viremia – median (vary between interquartiles [IQR]) DNA transcripts/ml

-1.14 (-1.88, -0.50)

0.37 (-0.72, 0.04)

0.051

Change in estimated glomerular filtration fee (eGFR) – imply (IQR) ml/min/1.73 m2

2.0 (-5.0, 4.0)

-6.0 (-8.5, -0.5)

0.217

About BK Virus (BKV)
BK Virus (BKV) is a polyomavirus that may be reactivated in immunosuppressed circumstances, resembling kidney transplantation. It’s a main reason for kidney transplant loss and transplant-related morbidity; There are at the moment no authorized remedies for BKV.

About MAU868
MAU868 has the power to neutralize an infection by stopping BKV virions from binding to host cells. MAU868 is at the moment present process a randomized, double-blind, placebo-controlled scientific trial to judge security, pharmacokinetics, and efficacy within the therapy of BKV in renal transplant sufferers. Vera holds an unique worldwide license to develop and market MAU868 in all indications obtained from Amplyx Prescription drugs, Inc. , an entirely owned subsidiary of Pfizer Inc.

About Vera
Vera Therapeutics is a late-stage biotechnology firm targeted on creating remedies for severe immune illnesses. Vera’s mission is to develop remedies that concentrate on the supply of immune illnesses with a view to change the usual of take care of sufferers. Vera’s lead candidate product is atacicept, a fusion protein that’s self-administered as subcutaneous injection as soon as weekly that inhibits each B-lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), which stimulates B cells and plasma cells to provide antibodies that contribute to Sure autoimmune illnesses, together with immunoglobulin nephropathy (IgAN), also called Berger’s illness, and lupus nephritis. As well as, Vera is evaluating further illnesses the place discount of autoantibodies by atacicept could also be clinically useful. Vera can be creating MAU868, a monoclonal antibody designed to neutralize an infection with BK virus, a polypoidoma virus that may have severe penalties in sure settings resembling kidney transplants. For extra info, please go to the web site www.veratx.com.

forward-looking statements
Statements on this press launch concerning issues, occasions, or outcomes that will happen sooner or later are “forward-looking statements” inside the which means of the Personal Securities Litigation Reform Act of 1995. These forward-looking statements embody statements concerning, amongst different issues, the chance that MAU868 is a first-class focused remedy particularly designed to neutralize BKV, Vera technique and regulatory points. As a result of such statements are topic to dangers and uncertainties, precise outcomes might differ materially from these expressed or implied by these forward-looking statements. Phrases resembling “plans,” “will,” “might,” “count on,” “potential,” and comparable expressions are meant to determine forward-looking statements. These forward-looking statements are primarily based on Vera’s present expectations and embody assumptions that will by no means materialize or might show incorrect. Precise outcomes might differ materially from these projected in such forward-looking statements attributable to varied dangers and uncertainties, together with, however not restricted to, dangers associated to the regulatory approval course of, outcomes of prior scientific trials might not be obtained in subsequent scientific trials, and dangers and uncertainties related to The enterprise of Vera usually, the impression of the COVID-19 pandemic, and different dangers described in Vera’s filings with the Securities and Change Fee. All forward-looking statements on this press launch converse solely as of the date they had been made and are primarily based on administration’s assumptions and estimates as of that date. Vera undertakes no obligation to replace such knowledge to replicate occasions that happen or circumstances that exist after the date on which they happen, besides as required by legislation.

For extra info, please contact:

Investor contact:
IR@veratx.com

Media contact:
Cathy Vincent
Greig Communications, Inc.
kathy@greigcommommunications.com