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NIAID Timeline of Events in Development of SQ109 | 1999 | Researchers, including Dr. Marina Protopopova, working in NIAID laboratory of Dr. Clifton E. Barry, III, screen more than 100,000 compounds for anti-TB activity. | | 1999-2002 | NIAID establishes a Cooperative Research and Development Agreement (CRADA) with Sequella Inc. | | 2000 | Dr. Protopopova and Sequella Inc. receive NIAID challenge grant to continue investigations into most promising compounds from earlier screening studies. | | 2001 | Supported by a National Cancer Institute/NIAID AIDS-related therapies development program, Sequella Inc. selects SQ109 as the most promising of three potential drug candidates and advances it to the next stage of development. | | 2003 | Sequella Inc. receives continued support from the NCI/NIAID drug development program to continue preclinical pharmacological testing of SQ109 and begin research into methods of producing the compound in sufficient quantities to allow for clinical trials. | | 2005 | NIAID awards second challenge grant to Sequella Inc. (Dr. Carol Nacy). In laboratory tests, SQ109 appears effective against drug-resistant TB and works synergistically with the first-line TB drugs rifampicin and isoniazid. | | March 2006 | NIH and Sequella Inc. sign worldwide licensing agreement, giving Sequella Inc. exclusive rights to continue development of SQ109. | | May 2006 | NIAID awards a Phase I clinical trial preparation grant to Dr. Protopopova. | | September 2006 | Sequella Inc. receives Investigational New Drug status for SQ109 from the U.S. Food and Drug Administration, paving the way to Phase I human clinical trials of the drug candidate. | | October 2007 | Sequella Inc. receives Orphan Drug Status for SQ109 from the U.S. Food and Drug Administration and the European Medicines Agency, entitling Sequella Inc. to seven years of market exclusivity for SQ109 for the treatment of patients with tuberculosis. |
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