TB47

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2021. Yu, W., Yusuf, B., Wang, S., Tian, X., Hameed, H., Lu, Z., Chiwala, G., Alam, M. S., Cook, G. M., Maslov, D. A., Zhong, N., & Zhang, T. (2021). Sterilizing Effects of Novel Regimens Containing TB47, Clofazimine, and Linezolid in a Murine Model of Tuberculosis. Antimicrobial agents and chemotherapy, 65(10), e0070621. https://doi.org/10.1128/AAC.00706-21. PMID: 34280022   https://pubmed.ncbi.nlm.nih.gov/34280022/ 

TBI-223

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Phase 1a began January 16, 2019.  Placebo-Controlled, Randomized, SAD Study to Evaluate the Safety, Tolerability, and PK of TBI-223 in Healthy NCT03758612

Presented at ASM Microbe 2017 Poster 50 Sunday:

MicuRx Pharmaceuticals, Inc.

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From website www.micurx.com accessed 8/28/2017:  "The MicuRx mission is to bring safer and effective antibacterial products for therapy of Gram-positive and Gram-negative infections to healthcare providers globally. In 2015, MicuRx reported successful results for its lead compound, MRX-1, from two oral Phase 2 studies in complicated skin and soft tissue infections, including methicillin-resistant Staphylococccus aureus (MRSA) infections, conducted in China and the USA. MRX-1 is currently in Phase 3 trials in China with additional clinical tests planned for the US."

Contezolid (MRX-4/MRX-1)

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MRX-I is a potent oxazolidinone antibiotic against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumoniae (PRSP), penicillin-intermediate S. pneumoniae (PISP), and vancomycin-resistant enterococci (VRE). Orally administered MRX-I showed the same or better efficacy than linezolid in systemic and local infection mouse models.

MRX-1 is in Phase 3 clinical trial in China.

US FDA: Development of New Tuberculosis Drug Regimens-Scientific and Clinical Design Considerations

The United States Food and Drug Administration held a public workshop regarding scientific and clinical trial design considerations for development of new tuberculosis drug regimens. This public workshop was intended to provide information for and gain perspective pertaining to development efforts around new in vitro and in vivo models, new biomarkers and tuberculosis diagnostics, assessing the contribution of 2 or more new components used in combination for to a tuberculosis regimen and clinical trial design challenges.

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