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- | MAU868 / Vera Therap
Journal: Non-clinical and clinical characterization of MAU868, a novel human-derived monoclonal neutralizing antibody targeting BK polyomavirus VP1. (Pubmed Central) - Nov 6, 2024
The pharmacokinetics of MAU868 was typical of a human IgG, with dose-proportional systemic exposure and an elimination half-life ranging between 23 and 30 days. These results demonstrate the potential of MAU868 as a first-in-class therapeutic agent for the treatment or prevention of BKPyV disease.
- MAU868 / Vera Therap
Association of baseline absolute lymphocyte count (ALC) with change in BK viral load (VL) in a randomised placebo-controlled study of MAU868 in kidney transplant recipients (KTR) (C / 13) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4014;
- ||||| MAU868 / Vera Therap
Clinical, P2 data: Don't miss Dr Stan Jordan at @ASNKidney 2022 #Kidneywk! He is presenting📅Sat 11/5/22 at 4:48 p.m. (SA-OR43 A) 📉Randomized Phase 2 Study of MAU868 vs. Placebo to Treat BK Viremia 💉🦠in #Kidney #Transplant Recipients! 📍W240 @StanleyCJordan2 (Twitter) - Nov 4, 2022
- MAU868 / Vera Therap
A Randomized Phase 2 Study of MAU868 vs. Placebo to Treat BK Viremia in Kidney Transplant Recipients (W240, Orange County Convention Center, West Building) - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4152;
These results support the further development of MAU868 as a therapy for BK viremia. Antiviral Effect and Effect on Kidney Function of MAU868 vs Placebo
- || MAU868 / Vera Therap
Trial completion, Trial completion date, Trial primary completion date: A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (clinicaltrials.gov) - Jul 23, 2022
P2, N=30, Completed, Sponsor: Vera Therapeutics, Inc.
Antiviral Effect and Effect on Kidney Function of MAU868 vs Placebo Recruiting --> Completed | Trial completion date: May 2023 --> Feb 2022 | Trial primary completion date: Feb 2023 --> Aug 2021
- |||| MAU868 / Vera Therap
Clinical: Promising results from MAU868 neutralizing Ab w improved viral load reduction and excellent safety profile #atc2022 @AST_IDCOP @AST_KPCOP (Twitter) - Jun 4, 2022
- MAU868 / Vera Therap
A Randomized Phase 2 Study Of Mau868 Vs Placebo To Treat Bk Viremia In Kidney Transplant Recipients (Hynes Ballroom B) - May 20, 2022 - Abstract #ATC2022ATC_1432;
MAU868 was well tolerated, and demonstrated significant BK antiviral activity in kidney transplant recipients with BK viremia. These results support the further development of MAU868 as a therapy for BK viremia.
- MAU868 / Amplyx Pharma
[VIRTUAL] Efficacy of MAU868, a Novel BKV Neutralizing Monoclonal Antibody (mAb), for the Treatment of Severe BK Virus Nephropathy (BKVN) After Kidney Transplant () - May 18, 2021 - Abstract #ATC2021ATC_2215;
MAU868 treatment of 2 patients with active BKVN was associated with viral load reductions and improvement or stabilization of renal function. The clinical utility of MAU868 for the prevention and/or treatment of BKV disease warrants further clinical investigation in randomized, controlled clinical trials because the medical need for a specific anti-BKV therapy remains unmet and the experiences reported here suggest benefit is possible.
- MAU868 / Amplyx Pharma
[VIRTUAL] A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_2831;
The ex vivo neutralizing activity suggests where the therapeutic range may be for the treatment or prevention of BKV disease. These results warrant further clinical investigation of MAU868 in patients with or at risk for BKV disease.
- MAU868 / Amplyx Pharma
[VIRTUAL] Pre-Clinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1281;
BKV variants with double or triple alanine substitutions at residues Y169, R170, or K172 were non-viable. Conclusions : The conserved key contact residues within the conformational epitope of VP1 may explain the broad-spectrum antiviral activity of MAU868 and its high in vitro barrier-to-resistance, ideal characteristics for a potential first-in-class therapeutic agent for the treatment or prevention of BKV disease.
- MAU868 / Amplyx Pharma
[VIRTUAL] A First-in-Human Study of MAU868, a Novel Neutralizing Antibody Against BK Virus (On-Demand) - Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_3187;
The ex vivo neutralizing activity suggests where the therapeutic range may be for the treatment or prevention of BKV disease. These results warrant further clinical investigation of MAU868 in patients with or at risk for BKV disease.
- MAU868 / Amplyx Pharma
[VIRTUAL] Preclinical Characterization of MAU868, a Novel Neutralizing Antibody Targeting BK Virus (On-Demand) - Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_3025;
The strict conservation of the contact residues within the conformational epitope of VP1 may explain the broad-spectrum antiviral activity of MAU868 and its high in vitro barrier-to-resistance, ideal characteristics for a potential first-in-class therapeutic agent for the treatment or prevention of BKV disease. Funding: Commercial Support
- || MAU868 / Vera Therap
Enrollment open, Trial initiation date: A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (clinicaltrials.gov) - Jul 14, 2020
P2, N=36, Recruiting, Sponsor: Amplyx Pharmaceuticals
Funding: Commercial Support Not yet recruiting --> Recruiting | Initiation date: Apr 2020 --> Jul 2020
- tacrolimus / Generic mfg., MAU868 / Amplyx Pharma
[VIRTUAL] Experience with a BKV-Specific, Neutralizing Monoclonal Antibody (MAU868) for Treatment of Severe BK Virus Nephropathy (BKVN) after Kidney Transplant (FDA EIND #139112) (Virtual) - May 29, 2020 - Abstract #ATC2020ATC_1529;
Treatment with MAU868 was associated with viral load reductions and improvements in renal function. The efficacy of MAU868 in the prevention and/or treatment of BKV disease warrants further clinical investigation.
- || MAU868 / Vera Therap
New P2 trial: A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (clinicaltrials.gov) - Mar 4, 2020
P2, N=36, Not yet recruiting, Sponsor: Amplyx Pharmaceuticals
- | MAU868 / Vera Therap
Enrollment change, Trial withdrawal: Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients (clinicaltrials.gov) - Dec 13, 2018
P2, N=0, Withdrawn, Sponsor: Novartis Pharmaceuticals
The efficacy of MAU868 in the prevention and/or treatment of BKV disease warrants further clinical investigation. N=96 --> 0 | Not yet recruiting --> Withdrawn
- || MAU868 / Vera Therap
Trial completion date, Trial initiation date: Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients (clinicaltrials.gov) - May 31, 2018
P2, N=96, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
N=96 --> 0 | Not yet recruiting --> Withdrawn Trial completion date: Jul 2020 --> Nov 2020 | Initiation date: Jun 2018 --> Oct 2018
- ||||| MAU868 / Vera Therap
New P2 trial: Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients (clinicaltrials.gov) - Mar 7, 2018
P2, N=96, Not yet recruiting, Sponsor: Novartis Pharmaceuticals