On World Tuberculosis Day, TB Alliance and the Medicines Patent Pool (MPP) announced a licensing agreement for the clinical development of sutezolid, an antibiotic drug candidate which demonstrated encouraging results in early studies. The sublicense pertains to the development of sutezolid in combination with other TB drugs and follows the MPP’s license for the treatment signed with patent holder The Johns Hopkins University in January.
“There are precious few novel drugs available for TB therapy and therefore every promising new candidate is greeted with much enthusiasm,” said Dr. Mel Spigelman, President and CEO of TB Alliance. “With the additional positive results from our current clinical trials we can thoroughly vet sutezolid in a variety of potentially transformative new TB regimens.”
TB is the cause of the largest killer of humanity, killing nearly 2 million people each year. The poor efficacy of existing TB drugs requires that they be administered in a multi drug regimen for at least six months. This results in poor patient compliance and leads to development of multidrug-‐resistant TB (MDR-‐TB) and extremely drug-‐resistant TB (XDR-‐TB). Decades of misuse of existing antibiotics and poor compliance have created an epidemic of drug resistance that threatens TB control programs worldwide.
New drugs and treatment regimens with activity against drug-‐susceptible and drug-‐resistant TB are desperately needed to manage this public health crisis.
Sutezolid is in the same class of drugs as linezolid (oxazolidinones), which is used in some countries as a treatment option for drug-resistant TB (DR-TB). Tests conducted over the past decade have indicated that sutezolid may have a better therapeutic potential than linezolid.
“Sutezolid is the first TB drug in the Medicines Patent Pool’s portfolio, and we are pleased with TB Alliance’s swiftness in sublicensing the candidate,” said Greg Perry, Executive Director of the Medicines Patent Pool. “We are grateful to the civil society coalition that pushed for the clinical development of sutezolid. If further studies are successful, this product could be a game-changer in improving options for patients.”
MPP’s license with The Johns Hopkins University grants the MPP the rights to sublicense sutezolid to product developers interested in further developing the treatment for both drug-susceptible and drug-resistant TB, and to combine sutezolid with a wide variety of other drugs.
TB is the world’s top infectious disease killer. According to the World Health Organization, 10.4 million people fell ill with TB and 1.8 million died from the disease in 2015. An estimated 580,000 patients were deemed eligible for MDR-TB treatment in 2015. According to the latest available data, the MDR-TB treatment success rate is only 52 percent.
“UNITAID strongly supports the TB Alliance-Medicines Patent Pool collaboration to jump-start the clinical development of the new tuberculosis treatment sutezolid,” said Lelio Marmora, Executive Director of UNITAID, the MPP’s funder. “This World Tuberculosis Day, we must re-double efforts to find better, faster-acting treatment solutions, especially for resistant forms of the disease.”