March 18, 2019

Research Roundup: Study finds safer & shorter treatment for Chagas, Trumps budget proposes cuts to biomedical research, and FDA accepts new drug application for pretomanid in combination TB regimen

Ansley Kahn
Senior Program Assistant
PATH/Mike Wang

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A phase II clinical trial, led by the Drugs for Neglected Diseases initiative (DNDi), found that a two-week treatment of benznidazole was just as effective in treating Chagas— a parasitic disease which causes permanent damage to the heart as well as the nervous and digestive systems—as the conventional eight-week treatment course. The shorter treatment means reduced side effects, which range from skin rashes to peripheral neuropathy, and thus also improved treatment adherence—both of which are critical for the control and elimination of Chagas disease. DNDi hopes to make the disease less debilitating for future patients “and turn this breakthrough discovery into a reality for people affected by the disease.”

On Monday, March 11, the Trump administration released its budget proposal for fiscal year 2020. While the budget proposal requested US$291 million for the President’s domestically-focused “Ending the HIV epidemic” plan, —which includes funding for biomedical interventions—the global health community has called out the proposed reduction in funding to fight HIV globally also included in the President’s 2020 budget proposal. Overall, the President’s Budget Request proposes deep cuts to biomedical research across a wide range of federal agencies and to global health programs at the Department of State and the US Agency for International Development.

TB Alliance announced that the US Food and Drug Administration (FDA) has accepted a new drug application for pretomanid, a novel tuberculosis (TB) drug candidate, as part of a treatment regimen for extensively drug-resistant TB; treatment-intolerant, multidrug-resistant TB; and treatment-nonresponsive, multidrug-resistant TB. Pretomanid would be used in combination with bedaquiline and linezolid. In a clinical trial in South Africa using this treatment regimen, 89 percent of study participants resolved their clinical infection after six months of treatment and six months of post-treatment follow up. The FDA granted priority review of this new drug application leveraging the Prescription Drug User Fee Act with an action date expected in the third quarter of this year.