WHO Updates Definition of XDR-TB

Last week, the World Health Organization (WHO) held a consultation to discuss the definition of extensively drug resistant (XDR) tuberculosis. The meeting was held to discuss novel treatment regimens and diagnostics for drug-resistant TB and determine its impact on the definition of XDR-TB. The meeting was held virtually with over 70 participants with country representatives, international organizations, agencies, NGOs, civil society, and academia.

Phase 1 Safety, Tolerability and Pharmacokinetics of BVL-GSK098

Submitted by zaidtanvir on

This is an exploratory, first-in-human (FIH), single-center, double-blind, randomized, placebo-controlled, single and multiple ascending oral dose study in healthy volunteers.The study will be divided into two parts that will be conducted sequentially. Part A is a SAD study to determine the safety, tolerability and PK of single oral doses of BVL-GSK098 in healthy volunteers. In addition, the last cohort of Part A will investigate the effect of food on the PK of BVL-GSK098.

Working Groups Seeking Online Curriculum Consultant

The Stop TB Partnership Working Group on New TB Vaccines (WGNV), Working Group on New TB Drugs (WGND), and New Diagnostics Working Group (NDWG) are developing an online course specifically designed for advocates and affected communities to provide a base of knowledge in TB research and to generate interest and engagement in TB research advocacy. The New Tools Working Groups (WGs) are seeking an online curriculum consultant/ writer for the course. The consultant will contract with the host organization for each of the WGs. 

TZY-5-84

Submitted by barbara on

Similar to PBTZ-169.  MIC reported as 0.15 ug/ml.  Active in vivo, orally bioavailable, 12.5 mg/kg

From: 126.com <lmllyx@126.com>
Sent: Monday, October 11, 2021 3:08 AM
To: Laughon, Barbara (NIH/NIAID) [E] <BLAUGHON@niaid.nih.gov>
Subject: Re:TZY-5-84

Dear Prof. Barbara E. Laughon,

        Nice to hear from you. 

JSF-3285

Submitted by barbara on

JSF-3285 is an indazole targeting KasA (beta-ketoacylsynthase) published in 2020 by Rutgers University.  JSF-3285 is a small molecule with potentcy in vitro and in vivo in mouse models of infection. It shows activitiy against DS, MDR, and XDR TB strains. KasA is a novel mechanism of action amongst current TB drugs. 

EBA, Safety and Tolerability of GSK3036656 in Subjects With Drug-sensitive Pulmonary Tuberculosis

Submitted by zaidtanvir on

GSK3036656 is a compound with a novel mechanism of action under development for the treatment of tuberculosis. It suppresses protein synthesis in MTB by selectively inhibiting the enzyme Leucyl t-ribose nucleic acid (RNA) synthetase. Thus, this study investigated the early bactericidal activity, safety and tolerability of GSK3036656 in up to four sequential cohorts of subjects with rifampicin-susceptible tuberculosis.

TB Trial Demonstrates Non-Inferiority of 4-Month Regimen for DS-TB Patients

On Thursday, October 21st, 2020, the U.S. Centers for Disease Control and Prevention's (CDC) TB Trials Consortium (TBTC)  announced results from their Phase 3, open-label trial: Study 31/A5349. The clinical trial identified a 4-month drug regimen composed of high-dose rifapentine, moxyifloxacin, pyrazinamide, and isoniazid that they concluded was non-inferior to the standard 6-month HRZE course of therapy for drug-sensitive TB patients.

BEAT-TB Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis

Submitted by barbara on

BEAT Tuberculosis is a phase 3, open label, multi-centre, randomized controlled trial. The purpose of this trial is to compare the efficacy and safety of a Study Strategy consisting of 6 months of bedaquiline (BDQ), delamanid (DLM), and linezolid (LNZ), with levofloxacin (LVX) and clofazimine (CFZ) compared to the current South African Standard of Care (Control Strategy) for 9 months for the treatment of rifampicin resistant (RR-TB) Tuberculosis.

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