Delamanid, Bedaquiline, OPC-167832

Delamanid + Bedaquiline + OPC-167832 10 mg

Delamanid + Bedaquiline + OPC-167832 30 mg

Delamanid + Bedaquiline + OPC-167832 90 mg

Control: RHEZ (6 months)

Arm 1: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg thrice-weekly [TIW]) + OPC-167832 (10 mg QD) for 17 weeks

Arm 2: DLM (300 mg QD) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (30 mg QD) for 17 weeks

Arm 3: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (90 mg QD) for 17 weeks

Phase 2b/c. 4-month Regimen of OPC-167832, Delamanid and Bedaquiline for DS Pulmonary TB

Arm 1: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg thrice-weekly [TIW]) + OPC-167832 (10 mg QD) for 17 weeks

Arm 2: DLM (300 mg QD) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (30 mg QD) for 17 weeks

Arm 3: DLM (300 mg once daily [QD]) + BDQ (400 mg QD x 2 weeks, then 200 mg TIW) + OPC-167832 (90 mg QD) for 17 weeks

Arm 4: RHEZ for 8 weeks followed by 18 weeks of rifampin and isoniazid (for a total of 26 weeks)

Shanghai Jiatan Biotech Ltd., subsidiary of Guangzhou JOYO Pharma Ltd., Shanghai, China

WX-081 Publication 2022

Sudapyridine (WX-081), a Novel Compound against Mycobacterium tuberculosis
Rong Yao,a,b Bin Wang,a,b Lei Fu,a,b Lei Li,c Kejun You,c Yong-Guo Li,c Yu Lua,b
a Beijing Key Laboratory of Drug Resistance Tuberculosis Research, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China
b Beijing Chest Hospital, Capital Medical University, Beijing, China
c Shanghai Jiatan Biotech Ltd., a subsidiary of Guangzhou JOYO Pharma Ltd., Shanghai, China
 

Sudapyridine (WX-081)

2022 Publication. Huang, Luo, Wang, Wan, Franzblau, Ding. Discovery and preclinical profile of sudapyridine (WX-081), a novel anti-tuberculosis agent. Bioorganic & Medicinal Chemistry Letters. Volume 71, 1 September 2022, 128824

DECODE- Delpazolid Dose-Finding and Combination Development Trial

This is an open label Phase IIb dose-finding, randomized, controlled study with a duration of 16 weeks of experimental therapy of Delpazolid (DZD) - Bedaquiline/Delamanid/ Moxifloxacin (BDM) in adult patients with newly diagnosed, smear positive, uncomplicated, drug sensitive pulmonary tuberculosis (TB) to evaluate the safety, efficacy, tolerability, pharmacokinetics and exposure/response-relationship of different doses of delpazolid in combination with bedaquiline, delamanid and moxifloxacin.

Sutezolid Dose-finding and Combination Evaluation (SUDOCU)

75 participants have been randomized to one of five arms (15 participants per arm) to receive study medication containing bedaquiline, delamanid, and moxifloxacin with different doses of sutezolid, ranging from 0mg sutezolid up to 800mg sutezolid twice a day. Participants are randomised and stratified by site and HIV status.

Participants visit the study clinic on a weekly basis for sputum collection, safety monitoring and receipt of study medication.

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