endTB

The endTB clinical trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened 9-month regimens for fluoroquinolone-susceptible multidrug-resistant tuberculosis (MDR-TB). Participants were assigned to experimental and control arms according to Bayesian outcome-adaptive randomization. The endTB randomized controlled clinical trial enrolled 754 participants across twelve sites in seven countries (Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, and South Africa).

DECISION

This is a phase 2B, open label study, that will compare the safety and efficacy of three experimental regimens consisting of bedaquiline and delamanid in combination with different doses of BTZ-043, a novel antibiotic, in adult participants with newly diagnosed, drug-sensitive pulmonary tuberculosis. Participants will be assigned to receive either one of the three BTZ-043-containing regimens or a comparator regimen consisting of bedaquiline, delamanid and moxifloxacin.

CLB073

Preclinical testing of CLB073 has identified the compound as having anti-Mtb activity. The compound is owned by Calibr and has been exclusively licesenced to Bill and Melinda Gates Medical Research Institute (GMRI). The compound was developed by David Russell and Brian VanderVen at Cornell University's College of Vetinary Medicine. 

CLB073 is active on adenyl cyclase (Rv1625c), which is involved in Mtb's ability to metabolize cholesterol. Cholesterol metabolism has recently been determined by experts to be an important new drug target. 

CLO-FAST

This study will compare a 3-month rifapentine (RPT)/clofazimine (CFZ)-containing regimen with CFZ loading dose versus 6-month standard of care (SOC) for drug-susceptible (DS) tuberculosis (TB).

Randomization will be stratified based on HIV status and the presence of advanced disease as determined by chest X-ray.

Participants will be randomized to one of three arms:

WISH Trial

The objective of this study is to demonstrate that the antibacterial activity of Sudapyridine (WX-081) is not inferior to Bedaquiline when added to a Background Regimen (BR) for treatment of rifampicin- resistant TB. Also, safety and clinical outcome will be evaluated.

This is a multicenter, randomized, double-blind, positive-controlled Phase III study to evaluate the efficacy and safety of Sudapyridine (WX-081) in combination with background medication (BR) in patients with rifampicin-resistant tuberculosis.

With NIH Funding, A New Consortium Aims to Improve TB Treatment

The National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) has issued a $30.8 million grant to the Preclinical Design and Clinical Translation of TB Regimens (PreDiCTR) consortium, a new consortium co-led by investigators from Weill Cornell Medicine; the University of California, San Francisco; Johns Hopkins Medicine; and Vanderbilt University Medical Center.

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