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Phase 1 TBA-354 Placed on Clinical Hold

TB Alliance announced today that it has voluntarily halted further dosing of TBA-354 in the ongoing Multiple Ascending Dose (MAD) Phase 1 study.

January 4, 2016

TB Alliance announced today that it has voluntarily halted further dosing of TBA-354 in the ongoing Multiple Ascending Dose (MAD) Phase 1 study. This action has prompted the United States Food and Drug Administration (FDA) to place the organization’s Investigational New Drug (IND) submission for TBA-354 on clinical hold. TBA-354, which had entered Phase 1 testing in early 2015, is from the nitroimidazole class of chemicals.

“The MAD study aims to assess the safety and pharmacokinetics of multiple daily doses of TBA-354. Based on unexpected signs detected in clinical trial participants who were administered the compound, we decided to suspend further dosing until we could better analyze the available data. This detailed analysis will define next steps,” said Mel Spigelman, MD, President and CEO of TB Alliance. “Regardless of the outcome of the analysis, the clinical hold on TBA-354 highlights the importance of and need for increased funding to scale up TB research to produce the necessary tools the world needs to stop this leading infectious disease killer.”

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