Sequella, Inc. has announced it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for SQ109, the company's proprietary lead drug candidate for treatment of pulmonary tuberculosis (TB).
With a mechanism of action distinct from other antibiotics used in TB therapy, SQ109 shows excellent in vitro activity against drug susceptible and drug resistant TB bacteria, including XDR-TB, as well as potent in vivo activity against pulmonary TB alone and with other TB drugs.
"This FDA Fast Track designation validates SQ109 as a potentially unique addition to the TB therapeutic armamentarium," said Dr. Carol Nacy, CEO of Sequella. "This is an important regulatory milestone and recognition that SQ109 may address unmet needs in TB therapy to improve and shorten the current treatment regimen."
According to a letter from the FDA, SQ109 received fast track designation based on the following: "SQ 109 has the potential to fulfill an unmet medical need, and the preclinical information available thus far demonstrates that SQ 109 has the potential to enhance the treatment of tuberculosis during the first two months of intensive therapy and to treat multi-drug resistant TB." The FDA letter also stated that: "In 2002 the estimated number of active cases of tuberculosis was 9 million, with approximately 2 million deaths, worldwide."
Mandated by the FDA Modernization Act of 1997, Fast Track designation expedites the development and review of a New Drug Application (NDA) for approval.