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Merck, known as MSD outside of the US and Canada, discovered the TB drug candidate TBD09, originally known as MK-7762, as part of the TB Drug Accelerator programme. This is a collaboration among biopharmaceutical companies, research organizations and universities.
It was with the support and leadership from the Gates Foundation that helped to accelerate the discovery and development of novel therapeutic candidates against TB TBD09, like linezolid which belongs to the class of antibiotics known as oxazolidinones. These antibiotics work by disrupting how the TB bacteria synthesize protein in order to survive and replicate, according Gates MRI
The World Health Organization’s formal recommendation of bedaquiline, pretomanid, linezolid (BPaL) and BPaLM (M = moxifloxacin) development of drug-resistant TB (DR-TB) may occur when treatment is discontinued before the infection is completely cured.
In an effort to shorten the duration of treatment irrespective of resistance to the currently available TB drugs, Merck licensed TBD09 to the Gates Medical Research Institute (MRI) for non-clinical and clinical studies to evaluate its potential in the new affordable combination treatment regimens for TB.
Gates MRI recently completed an initial phase 1 clinical trial, evaluating the safety, tolerability, and pharmacokinetics of TBD09 in adults, and launched a second phase 1 trial in September 2025.
WHO reports TB infected 10.7 million in 2024 and 1.23 million succumbed. It is preventable and curable, yet it is still the most lethal infectious disease in the world. Infections are difficult to cure, requiring a combination of strong antibiotics administered over minimum of six months.
Now WHO recommendation of the bedaquiline, pretomanid, linezolid (BPaL) and BPaLM (M = moxifloxacin) oral drug combination regimens in 2022 provided a cure for DR-TB reducing treatment from 18 months to 6 months with much-improved outcomes.
The linchpin of these drug regimens is linezolid, a repurposed antibiotic that works well against TB bacteria, Mycobacterium tuberculosis. However, many patients are unable to tolerate linezolid for the duration of treatment due to its adverse effects on the human body, including suppression of the bone marrow and its production of various blood cell lines and peripheral neuropathy, said researchers from National Institutes of Health (NIH), Merck and the Gates MRI in a paper published in Nature Medicine.
TBD09 was shown to be active against a wide-range of drug-sensitive and drug-resistant clinical isolates and showed similar bactericidal activity as linezolid. Preclinical studies also indicated that TBD09 may potentially have an improved tolerability profile compared to linezolid, said the scientists in the paper.
Charles Wells, Ad interim chief medical officer, Gates MRI, and a co-author of the Nature Medicine paper highlighted about TBD09 and how cross-sector collaboration is powering the pipeline of potential new TB drugs.
As plans move forward to evaluate TBD09 in a phase 2 trial, US FDA has granted TBD09 the designations ‘Qualified Infectious Disease Product’ (QIDP) and ‘Fast Track’, recognizing the high unmet need and potential to provide a new option for patients with TB. These designations, granted to promising candidates with the potential to address critical and unmet medical needs, providing eligibility for a priority review, said the researchers.
Merck, known as MSD outside of the US and Canada, discovered the TB drug candidate TBD09, originally known as MK-7762, as part of the TB Drug Accelerator programme. This is a collaboration among biopharmaceutical companies, research organizations and universities.
It was with the support and leadership from the Gates Foundation that helped to accelerate the discovery and development of novel therapeutic candidates against TB TBD09, like linezolid which belongs to the class of antibiotics known as oxazolidinones. These antibiotics work by disrupting how the TB bacteria synthesize protein in order to survive and replicate, according Gates MRI.
The World Health Organization’s formal recommendation of bedaquiline, pretomanid, linezolid (BPaL) and BPaLM (M = moxifloxacin) development of drug-resistant TB (DR-TB) may occur when treatment is discontinued before the infection is completely cured.
In an effort to shorten the duration of treatment irrespective of resistance to the currently available TB drugs, Merck licensed TBD09 to the Gates Medical Research Institute (MRI) for non-clinical and clinical studies to evaluate its potential in the new affordable combination treatment regimens for TB.
Gates MRI recently completed an initial phase 1 clinical trial, evaluating the safety, tolerability, and pharmacokinetics of TBD09 in adults, and launched a second phase 1 trial in September 2025.
WHO reports TB infected 10.7 million in 2024 and 1.23 million succumbed. It is preventable and curable, yet it is still the most lethal infectious disease in the world. Infections are difficult to cure, requiring a combination of strong antibiotics administered over minimum of six months.
Now WHO recommendation of the bedaquiline, pretomanid, linezolid (BPaL) and BPaLM (M = moxifloxacin) oral drug combination regimens in 2022 provided a cure for DR-TB reducing treatment from 18 months to 6 months with much-improved outcomes.
The linchpin of these drug regimens is linezolid, a repurposed antibiotic that works well against TB bacteria, Mycobacterium tuberculosis. However, many patients are unable to tolerate linezolid for the duration of treatment due to its adverse effects on the human body, including suppression of the bone marrow and its production of various blood cell lines and peripheral neuropathy, said researchers from National Institutes of Health (NIH), Merck and the Gates MRI in a paper published in Nature Medicine.
TBD09 was shown to be active against a wide-range of drug-sensitive and drug-resistant clinical isolates and showed similar bactericidal activity as linezolid. Preclinical studies also indicated that TBD09 may potentially have an improved tolerability profile compared to linezolid, said the scientists in the paper.
Charles Wells, Ad interim chief medical officer, Gates MRI, and a co-author of the Nature Medicine paper highlighted about TBD09 and how cross-sector collaboration is powering the pipeline of potential new TB drugs.
As plans move forward to evaluate TBD09 in a phase 2 trial, US FDA has granted TBD09 the designations ‘Qualified Infectious Disease Product’ (QIDP) and ‘Fast Track’, recognizing the high unmet need and potential to provide a new option for patients with TB. These designations, granted to promising candidates with the potential to address critical and unmet medical needs, providing eligibility for a priority review, said the researchers.
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