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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, specifically BK viremia in kidney transplant recipients. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
MAU868 is being developed by Vera Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VERA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with BK virus infection.
MAU868 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not yet received regulatory approval. Further studies may be needed to establish its safety and efficacy profile.
MAU868 has been studied in a Phase 2 clinical trial identified as NCT04294472, titled "A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients." This trial was completed and enrolled 30 participants in the United States and Canada.
No alternative names for MAU868 have been disclosed. It is identified solely by its investigational code name MAU868 in clinical trial registries and by its developer, Vera Therapeutics, Inc.