NEW YORK (December 15, 2020)—TB Alliance announced that on December 1, 2020 the first dose was administered to a patient as part of a new Phase 1 study of its novel compound TBAJ-587 in healthy adult volunteers. New treatment options are urgently needed, especially as there is growing resistance to available drugs to treat tuberculosis (TB).
“We are excited to announce the first healthy volunteer dosed with TBAJ-587, as this is an important step in the development of new treatment options for people with TB,” said Mel Spigelman, MD, President and CEO of TB Alliance. “We are dedicated to expanding the drug development pipeline and advancing the development of novel compounds as part of future TB regimens that are faster, simpler and safer for patients.”
TBAJ-587 is a small molecule belonging to the diarylquinoline class which has demonstrated a superior preclinical profile against mycobacterium tuberculosis (M. tb) in preclinical studies and has been shown to inhibit the electron transport chain by direct inhibition of M.tb ATP synthase – an enzyme that contributes to energy storage within the tuberculosis bacterium.
Further development and design of the Phase 1 study has been undertaken by the ERA4TB project within the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry that facilitates the development of medicines, especially in areas of unmet medical need, in partnership with TB Alliance. Phase 1 study participants are receiving treatment in the Netherlands, through QPS Netherlands, an IMI partner. QPS Holdings LLC is a global clinical research organization (CRO) specializing in discovery, preclinical and clinical drug development research. The Ministry of Foreign Affairs in the Netherlands also supports the work of TB Alliance and the advancement of TB research and drug development.
“QPS values the work that the TB Alliance is doing to find faster-acting and affordable drug regimens to fight TB and we are very happy to be their partner in this Phase I clinical trial. We have developed strict protocols to enable our facilities to continue to conduct clinical trials during the Covid-19 pandemic, and look forward to completing this trial with the staff and study subjects’ safety as our top priority,” said, Wim Tamminga, PhD, Senior Vice President and Global Head of Early Phase Clinical at QPS Netherlands.
About TB Alliance
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany’s Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (Korea), Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Korea International Cooperation Agency, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Diseases, Netherlands Ministry of Foreign Affairs, Republic of Korea’s Ministry of Foreign Affairs, United Kingdom Department for International Development, and the United States Agency for International Development. For more information, please visit: www.tballiance.org
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853989. The JU receives support from the European Union’s Horizon 2020 Research and Innovation Programme and EFPIA and Global Alliance for TB Drug Development Non-Profit Organisation, Bill & Melinda Gates Foundation, University of Dundee.