19 October 2022 - - US-based pharmaceutical company Merck, (NYSE: MRK) and the Bill and Melinda Gates Medical Research Institute (Gates MRI) have inked a licensing agreement for two preclinical antibacterial candidates for evaluation as potential components of combination regimens for the treatment of tuberculosis, the principals said.

These candidates were discovered by Merck scientists as part of the TB Drug Accelerator.

The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB.

The initiative was established with support and leadership from the Bill and Melinda Gates Foundation.

Under the agreement, Merck has granted the Gates MRI an exclusive global license for MK-7762 and MK-3854.

In furtherance of its charitable purpose, Gates MRI will conduct non-clinical and clinical studies of these candidates to determine their potential for inclusion in new affordable combination treatment regimens for TB with the aim of shortening the duration of treatment irrespective of resistance to the currently available TB drugs.

In vitro and in vivo evaluation of MK-7762 and MK-3854 have shown that both candidates have potent antibacterial activity against Mycobacterium tuberculosis, the organism that causes tuberculosis, including some strains known to be resistant to current therapies.

Tuberculosis is a major global cause of illness, disability, and is one of the leading causes of death from an infectious disease worldwide, responsible for an estimated 1.5 m deaths per year.

The most commonly used drug regimen for the treatment of drug-sensitive TB requires patients to take multiple drugs for up to six months with routine clinical monitoring.

Patients with drug-resistant forms of the infection can face longer and more complex treatment journeys, often with significant side effects that require increased monitoring.

The need for drug-resistance testing prior to treatment initiation is an added challenge.

A substantially shorter drug regimen for the treatment of both drug-susceptible and drug-resistant forms of TB could provide a significant benefit to both patients and health systems and may overcome the need for accompanying drug-resistance testing.

The Bill and Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health.