2022 Publication. Yao et al. Sudapyridine (WX-081), a Novel Compound against Mycobacterium tuberculosis. Microbiol Spectrum. 10.1. e02477-21. PMCID: PMC8849072
From the abstract: Investigators in China report " a new analog of bedaquiline, sudapyridine (WX-081), was selected as a potential new antituberculosis candidate to move into clinical trials. Here, we evaluated WX-081's overall preclinical profile, including efficacy, pharmacokinetics, and toxicology. The in vitro activity of WX-081 against drug-sensitive and drug-resistant tuberculosis was comparable to that of BDQ, and there was comparable efficacy between WX-081 and BDQ in both acute and chronic mouse tuberculosis models using low-dose aerosol infection. Moreover, WX-081 improved pharmacokinetic parameters and, more importantly, had no adverse effects on blood pressure, heart rate, or qualitative ECG parameters from nonclinical toxicology studies. WX-081 is under investigation in a phase 2 study in patients." And from the Shanghai Jiatan Biotech Ltd., a subsidiary of Guangzhou JOYO Pharma Ltd., Shanghai, China the following updates were provided October 2021:
1. Full Phase I including SAD, Food Effect and MAD completed and CSR wrapped up.
2. Phase II trial including EBA and extension for primary efficacy is near Last Patient-In, and expect to complete in the 1st half of 2022.
3. Now heading to Phase III preparation including Protocol Design and Site Selection, and plan to start Phase III in the 1Q of 2022 in China.
4. Long-term nonclinical tox study including 26 weeks in rat and 39 weeks in dog completed.