- New evaluation of Phase 2a JANUS scientific trial confirmed atacicept lowered immune advanced ranges in sufferers with IgA nephropathy (IgAN)
- Atacicept is the primary therapeutic to point out discount in all of the three first hits of IgAN pathogenesis – serum galactose-deficient IgA1 (Gd-IgA1), anti-Gd-IgA1, and now immune advanced ranges
- Final outcomes from the Phase 2 scientific trial of MAU868 versus placebo confirmed MAU868 was effectively tolerated and demonstrated clinically significant BK antiviral exercise by way of 36 weeks in kidney transplant sufferers with BK viremia
BRISBANE, Calif., Nov. 05, 2022 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology firm centered on growing and commercializing transformative remedies for sufferers with severe immunological ailments, right now introduced new scientific information offered on the Company’s two product candidates, atacicept in immunoglobulin A nephropathy (IgAN) and MAU868 in kidney transplant. These information have been offered in poster and oral shows, respectively on the American Society of Nephrology (ASN) Kidney Week 2022 Annual Meeting, held November 3-6, 2022 in Orlando, Florida.
The poster presentation on atacicept included a brand new evaluation of beforehand offered scientific information from the Phase 2a JANUS scientific trial evaluating atacicept in sufferers with IgAN that confirmed atacicept lowered immune advanced ranges in sufferers with IgAN. Atacicept is the primary therapeutic to point out discount in all of the primary three hits of IgAN pathogenesis – serum galactose-deficient IgA1 (Gd-IgA1), anti-Gd-IgA1, and now immune advanced ranges. The oral presentation on MAU868 included remaining outcomes from the Phase 2 scientific trial of MAU868 versus placebo to deal with BK Virus (BKV) in kidney transplant sufferers that confirmed MAU868 was effectively tolerated and demonstrated clinically significant BK antiviral exercise by way of 36 weeks in kidney transplant sufferers with BK viremia.
Details of the shows are as follows:
| Title: | Atacicept Reduces Serum Immune Complex Levels in Patients with Immunoglobulin A Nephropathy (IgAN) |
| Presenter: | Jonathan Barratt, Ph.D., FRCP, The Mayer Professor of Renal Medicine, University of Leicester, U.Ok. |
| Abstract Number: | SA-PO655 (poster presentation) |
IgA nephropathy (IgAN) is an autoimmune illness pushed by a multi-hit pathogenesis that entails B-cell priming. Gd-IgA1 performs a central function in IgAN pathogenesis and because the intrinsic antigen is the primary hit within the illness pathogenesis. The second hit is the event of antibodies to the hinge area of Gd-IgA1, which then results in formation of immune complexes (third hit). These circulating immune complexes then deposit within the kidney and trigger progressive renal damage (fourth hit). The Phase 2a randomized, placebo-controlled JANUS trial confirmed that atacicept was the primary therapeutic to lower circulatory Gd-IgA1 in IgAN sufferers and additional evaluation of these outcomes confirmed that atacicept lowered anti-Gd-IgA1 antibodies. This evaluation investigated whether or not atacicept may also scale back serum immune complexes.
JANUS sufferers have been evaluated for serum IgA-IgG immune advanced ranges by ELISA at baseline, weeks 4, 12, 24, 48, and 72. Results confirmed a lower in serum IgA-IgG immune advanced ranges was noticed in each atacicept 25 mg and 75 mg teams over time. The 150 mg dose was not evaluated within the JANUS trial. At 24 weeks, the imply % change from baseline was a 17 % lower for atacicept 25 mg and a 21 % lower for atacicept 75 mg, and a 3 % lower for placebo. At 72 weeks, a 29 % lower for atacicept 25 mg, 26 % lower for atacicept 75 mg, and 13 lower for placebo was noticed.
“The ability of atacicept to decrease serum immune complex levels, as well as both circulatory Gd-IgA1 and anti-Gd-IgA1 antibodies, both of which are central to the pathogenesis and progression of IgAN, support its potential as a disease-modifying therapy for patients with IgAN,” stated Dr. Barratt.
Celia Lin, M.D., Chief Medical Officer at Vera Therapeutics, commented, “IgAN represents a high unmet medical need in the world, with an estimated 400,000 patients in the U.S., the European Union, and Japan – up to half of whom will develop end-stage renal disease within 20 years from initial diagnosis, requiring dialysis or kidney transplant. Research has shown that immune complex is a key component in the pathogenesis of IgAN. This is the first time we are seeing any investigational or approved therapy result in reduced immune complex levels in IgAN patients, and further shows that atacicept can target the upstream sources of disease in IgAN. We look forward to sharing new data of atacicept in IgAN – the topline results of our Phase 2b ORIGIN clinical trial – in early Q1 2023.”
| Title: | A Randomized Phase 2 Study of MAU868 vs. Placebo to Treat BK Viremia in Kidney Transplant Recipients |
| Presenter: | Stanley C. Jordan, M.D., FASN, FAST, Director of Nephrology & Transplant Immunology, Cedars-Sinai Medical Center, Professor of Pediatrics and Medicine on the David Geffen School of Medicine at University of California, Los Angeles |
| Abstract Number: | SA-OR43 (oral presentation) |
BK Virus (BKV) is a polyoma virus that may be reactivated in settings of immunosuppression, comparable to in kidney transplant. It is a number one trigger of kidney transplant loss and transplant-associated morbidity; there are presently no permitted remedies for BKV.
This Phase 2, randomized, double-blind, placebo-controlled scientific trial evaluated the security and efficacy of MAU868 in sufferers who obtained a kidney transplant inside one yr of enrollment and, inside 10 days of enrollment, had BK viremia. Patients obtained MAU868 or placebo intravenously (IV) each 28 days for 12 weeks, with 24 weeks follow-up. In this scientific trial, 20 sufferers obtained MAU868 and eight sufferers obtained placebo; all sufferers accomplished 12 weeks of therapy. Baseline traits have been comparable between teams. The major endpoint was security and tolerability; antiviral exercise was assessed in secondary and post-hoc analyses.
This evaluation reported efficacy outcomes at 16 and 36 weeks for 2 cohorts: MAU868 1350 mg IV x4 doses, and MAU868 6750 mg IV adopted by MAU868 1350 mg IV x3 doses. Results confirmed that the antiviral impact was increased within the MAU868 group than the placebo group at week 16 and sustained by way of week 36 (see Table beneath). Further, MAU868 was effectively tolerated, with a comparable frequency of adversarial occasions and severe adversarial occasions between teams by way of week 36. There have been two deaths within the MAU868 group resulting from COVID-19 an infection deemed unrelated to check drug.
Table: Antiviral Effect of MAU868 vs. Placebo at Week 36
“Reactivation of BKV infections can cause kidney disease in immunocompromised patients, leading to increased morbidity and mortality factors in kidney transplant recipients. BKV nephropathy is a leading cause of allograft loss in kidney transplant recipients and there are no approved effective or BKV-specific therapies,” stated Dr. Jordan. “These final results from the Phase 2 clinical trial showed that MAU868 was well tolerated and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia up to week 36. These data support the further development of MAU868 as a therapy for BK viremia.”
Dr. Lin commented, “MAU868 is a first-in-class targeted therapy specifically designed to neutralize BKV. We plan to initiate a Phase 2b or Phase 3 clinical trial of MAU868 in kidney transplant patients with BK Virus viremia in 2023, so that we can bring patients a treatment option as rapidly as possible.”
The posters offered throughout the American Society of Nephrology Kidney Week 2022 Annual Meeting will likely be out there on the Company’s web site at https://ir.veratx.com/news-events/presentations.
About Atacicept
Atacicept is an investigational recombinant fusion protein self-administered as a subcutaneous injection as soon as weekly that comprises the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B lymphocyte stimulator (BlyS) and a proliferation-inducing ligand (APRIL). These cytokines are members of the tumor necrosis issue household that promote B-cell survival and autoantibody manufacturing related to sure autoimmune ailments, together with IgA nephropathy (IgAN) and lupus nephritis. Atacicept confirmed a dose-dependent impact on key biomarkers and scientific markers in a Phase 2a scientific examine in sufferers with IgAN. Vera believes atacicept is positioned for best-in-class potential, concentrating on B cells and plasma cells to scale back autoantibodies and having been administered to greater than 1,400 sufferers in scientific research throughout totally different indications.
About MAU868
MAU868, a first-in-class monoclonal antibody, has the potential to neutralize an infection by blocking BK Virus (BKV) virions from binding to host cells. BK Virus is a polyoma virus that may be reactivated in settings of immunosuppression, comparable to in kidney transplant. It is a number one trigger of kidney transplant loss and transplant-associated morbidity; there are presently no permitted remedies for BKV. Vera holds an unique worldwide license from Amplyx Pharmaceuticals, Inc., an entirely owned subsidiary of Pfizer Inc., for the event and commercialization of MAU868 in all indications.
About Vera
Vera Therapeutics is a late-stage biotechnology firm centered on growing remedies for severe immunological ailments. Vera’s mission is to advance remedies that focus on the supply of immunologic ailments with a view to change the usual of take care of sufferers. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection as soon as weekly that blocks each B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to supply autoantibodies contributing to sure autoimmune ailments, together with IgA nephropathy (IgAN), often known as Berger’s illness, and lupus nephritis. In addition, Vera is evaluating extra ailments the place the discount of autoantibodies by atacicept could show medically helpful. Vera can be growing MAU868, a monoclonal antibody designed to neutralize an infection with BK Virus, a polyomavirus that may have devastating penalties in sure settings comparable to kidney transplant. For extra data, please go to www.veratx.com.
Forward-looking Statements
Statements contained on this press launch relating to issues, occasions or outcomes that will happen sooner or later are “forward-looking statements” throughout the that means of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements embrace statements relating to, amongst different issues, the initiation of a Phase 2b or Phase 3 scientific trial of MAU868 in kidney transplant sufferers with BK Virus viremia, the outcomes of Vera’s Phase 2b ORIGIN trial, the potential for MAU868 to be a first-in-class focused remedy particularly designed to neutralize BKV, and different statements relating to Vera’s product candidates, technique, and regulatory issues. Because such statements are topic to dangers and uncertainties, precise outcomes could differ materially from these expressed or implied by such forward-looking statements. Words comparable to “potential,” and comparable expressions are meant to establish forward-looking statements. These forward-looking statements are based mostly upon Vera’s present expectations and contain assumptions that will by no means materialize or could show to be incorrect. Actual outcomes might differ materially from these anticipated in such forward-looking statements because of this of numerous dangers and uncertainties, which embrace, with out limitation, dangers associated to the regulatory approval course of, outcomes of earlier scientific trials will not be obtained in later scientific trials, dangers and uncertainties related to Vera’s business typically, the impression of geopolitical and macroeconomic occasions, together with the COVID-19 pandemic, and the opposite dangers described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained on this press launch converse solely as of the date on which they have been made and are based mostly on administration’s assumptions and estimates as of such date. Vera undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they have been made, besides as required by legislation.
For extra data, please contact:
Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
[email protected]
Media Contact:
Kathy Vincent
Greig Communications, Inc.
[email protected]
A photograph accompanying this announcement is out there at https://www.globenewswire.com/NewsRoom/AttachmentNg/e9c7e19e-2da0-44ff-8969-a22d6e928182
