The Medicines Patent Pool sublicenses sutezolid, an investigational drug for TB treatment, paving the way for clinical development

Geneva and Cambridge MA – The Medicines Patent Pool (MPP) and the Bill & Melinda Gates Medical Research Institute (Gates MRI) signed an agreement today to advance the development of investigational sutezolid-containing TB drug regimens, especially for low- and middle-income countries, where most people with TB live. The drug candidate sutezolid, in combination with other drugs, could potentially be used as an all-oral, shortened regimen for all forms of TB, including multidrug-resistant TB (MDR-TB).

In October 2019, MPP and Pfizer entered into a licence agreement, which granted MPP rights to sublicense to third parties the patents and know-how relating to the use of sutezolid (formerly known as PNU-100480), a promising antibiotic drug candidate, in combination with other agents for the prevention and/or treatment of TB. Gates MRI is the first recipient of such a sublicence. The sublicence allows Gates MRI to access Pfizer’s existing preclinical, phase 1 and phase 2a clinical study data and results with the aim of further developing this potential component of future TB regimens, should the data be supportive.

“We need better TB treatments in our arsenal to address the resistant strains of TB bacteria,” said MPP’s Executive Director Charles Gore. “If we are to outpace this killer disease that claims 4,500 lives every day, we need to have promising drugs in the TB R&D pipeline at all times. Sutezolid is one such candidate and MPP is excited that Gates MRI is undertaking development program to study it for TB.”

“Gates MRI is proud to sublicense sutezolid from MPP. We look forward to studying this promising drug candidate, consistent with our ultimate goal to accelerate the end of TB and in the interim, bring hope to the millions suffering from this serious infectious disease. We intend to pursue development of a TB regimen that may include sutezolid as we attempt to tackle drug-sensitive and drug-resistant tuberculosis,” said Dr. Charles Wells, Clinical Development Leader at the Bill & Melinda Gates Medical Research Institute.

According to the World Health Organization, TB is one of the top 10 causes of death worldwide. In 2019, 10 million people fell ill with TB, and 1.4 million died from the disease. MDR-TB remains a public health crisis and a health security threat, with nearly 465,000 incident cases in 2019.^[1]

Supporting quotes

“With the persisting number of people falling ill with drug-resistant TB every year and the exacerbated situation with the COVID-19 pandemic, newer medicines like sutezolid are needed to develop new, efficacious and shorter regimens to treat drug-resistant TB. WHO welcomes this announcement from MPP and Gates MRI as a right step in this direction.”
– Dr Tereza Kasaeva, Director of the Global TB Programme at the World Health Organization

“If we are to end the tuberculosis epidemic we will need more new drugs and regimens and for them to be developed with the sharing of data and intellectual property using mechanisms such as the Medicines Patent Pool to support their timely development and access. We welcome this announcement and look forward to following the progress of sutezolid through the clinical trials supported by the Gates MRI.”
– Grania Brigden, Director, Tuberculosis Department, The International Union Against Tuberculosis and Lung Disease (The Union)

“Unitaid welcomes this new agreement between MPP and Gates MRI which will pave the way for the development of a promising new drug against TB. Identifying and developing better, shorter and easy-to-use regimens for all forms of TB, including multidrug-resistant TB is crucial to eliminate the disease in low- and middle-income countries.”
– Philippe Duneton, Executive Director, Unitaid

^[1] Tuberculosis Fact Sheet, World Health Organization