TAbS







Potravitug Clinical Naked monospecific

Antibody Information

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

Therapeutic information

Target(s) BK virus
Indications of clinical studies BK virus infection
Primary therapeutic area Infectious diseases

Development stage information


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 information

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

Description/comment

AntiBKV is a fully human highly neutralising antibody against BKV; derived from clinically selected convalescent BKV patients

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None