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MAU868 · 1 trial · 1 indication
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses |
| Cohort 2 | EXPERIMENTAL | Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses |
| Cohort 3 | EXPERIMENTAL | Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses |
| Placebo Cohort 1, 2, 3 | PLACEBO_COMPARATOR | 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses |
| Name | Type | Description |
|---|---|---|
| MAU868 | DRUG | MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells |
| Placebo | OTHER | 250 mL D5W placebo IV to be labeled to match that of MAU868 |
Inclusion Criteria: * Be a male or female 18 years of age or older. * Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment * Documented BKV viremia based on local or central laboratory testing within 10 days Exclusion Criteria: * A BKV plasma viral load which ...
MAU868 is an investigational small molecule being developed for the treatment of BK virus infection. It has been studied specifically in kidney transplant recipients with BK viremia, a condition in which BK virus replicates in the blood after transplantation. MAU868 is not approved and remains in clinical development.
MAU868 targets the BK virus. It is a small molecule directed against the virus itself, which places it in the antiviral class of agents rather than a host-directed therapy. Targeting BK virus is intended to reduce viral replication in patients with BK viremia.
MAU868 is being developed by Vera Therapeutics, Inc., which trades on the Nasdaq under the ticker VERA. Vera Therapeutics is the sponsor of the clinical program evaluating MAU868 in BK virus infection.
MAU868 is in Phase 2 development. The completed Phase 2 study evaluated the drug in kidney transplant recipients with BK viremia. MAU868 is investigational and has not been approved by the FDA for any indication.
MAU868 has been evaluated in one Phase 2 trial, NCT04294472, titled A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients. The trial enrolled 30 adults, was randomized, double blind, and placebo controlled, and was conducted in the United States and Canada. It is now completed.