Promising New TB Drug Given Special Status By US And European Regulators

Currently, TB patients must adhere to a complex treatment regimen over a six- to nine-month period. This demanding schedule often results in patients skipping treatment doses, which has given rise to drug-resistant strains of M. tuberculosis, including multi-drug-resistant (MDR) and, more recently, extensively drug-resistant (XDR) TB.

SQ109, an antimicrobial agent developed through a partnership between the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health, and the biotech company Sequella, Inc., has recently been granted "orphan drug" status by the U.S. Food and Drug Administration and the European Medicines Agency for development against drug-susceptible and drug-resistant TB.

This orphan designation will help accelerate clinical testing of the drug; SQ109 (in combination with other TB drugs) may help establish simpler and more effective treatment regimens for the disease.

Recent events have underscored the immense problem of antimicrobial resistance, including the growing threat of MDR-TB, according to NIAID Director Anthony S. Fauci, M.D. The advancement of SQ109 to a clinical candidate, he says, demonstrates the key role that public-private partnerships can play in developing new interventions to improve public health.

SQ109 was discovered by NIAID scientists in 1999 and developed with grant and contract support from NIAID and contributions by the National Cancer Institute/NIAID Inter-Institute Program for the Development of AIDS-related Therapeutics. NIAID licensed the SQ109 technology to Sequella in March 2006 under a Cooperative Research and Development Agreement.