Entry ID | 299 |
INN | Potravitug |
Status | Clinical |
Drug code(s) | AntiBKV, MTX-005, mAb129 |
Brand name | None |
mAb sequence source | mAb human |
General Molecular Category | Naked monospecific |
Format, general category | Full length Ab |
Format details | None |
Isotype (Fc) | TBD |
Light chain isotype | TBD |
Linker | None |
Ave. DAR | None |
Conjugated/fused moiety | None |
Discovery method/technology | None |
Target(s) | BK virus |
Indications of clinical studies | BK virus infection |
Primary therapeutic area | Infectious diseases |
Most advanced stage of development (global) | Phase 2/3 |
Status | Active |
Start of clinical phase (IND filing or first Phase 1) | May 15, 2022 |
Start of Phase 2 | |
Start of Phase 3 | April 10, 2023 |
Date BLA/NDA submitted to FDA | |
Year of first approval (global) | None |
Date of first US approval | |
INN, US product name | None |
US or EU approved indications | None |
Company | Memo Therapeutics AG |
Licensee/Partner | None |
Comments about company or candidate | May 2023: Fast track designation granted by FDA NCT05769582 Phase 2/3 study BKV Infection in Kidney Transplant Recipients is started in April 2023. May 31, 2022 – Memo Therapeutics AG announced today the initiation of a phase 1 clinical study targeting BK polyomavirus (“BKV”) infection in renal transplant patients. The phase 1, single-blind, partially randomized, placebo-controlled study will assess safety, tolerability, and pharmacokinetics of single and multiple ascending intravenous doses of MTX-005 in up to 56 healthy adult volunteers (ClinicalTrials.gov Identifier: NCT05358106). NCT05358106 Phase 1 started in May 2022; BLA expected in 2024. |
Full address of company | Wagistrasse 27 8952 Schlieren / Zurich Switzerland Europe Switzerland https://memo-therapeutics.com/contact.html |
AntiBKV is a fully human highly neutralising antibody against BKV; derived from clinically selected convalescent BKV patients
Anticipated events | None |
Factor(s) contributing to discontinuation | None |