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.
SQ109 is an orally active small molecule antibiotic that inhibits cell wall synthesis and acts on multiple cellular pathways in a select group of microorganisms, including Mycobacterium tuberculosis, the bacteria that cause TB. SQ109 enhances, both in vitro and in vivo, the activity of the anti- tubercular drugs isoniazid and rifampin, thereby shortening by 25% the time required to cure mice of experimental TB. SQ109 is currently in Phase I clinical trials under a US IND, and could replace one or more of the current first-line anti-TB drugs, simplify therapy, and shorten the treatment regimen. Since 2000, Sequella has applied its scientific expertise in TB research and product development to identify, characterize, and complete preclinical evaluation of SQ109. SQ109 was developed in partnership with the NIH, with several grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the assistance of the NIAID and the National Cancer Institute Inter-Institute Program (NCI IIP) for IND-enabling studies.