SEQUELLA'S TB DRUG GRANTED FAST-TRACK STATUS

Sequella has received fast-track designation from the 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-resistant TB, including extremely drug-resistant TB. The drug is currently in Phase I clinical trials.

According to the FDA's letter to Sequella: "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 multidrug-resistant TB."

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 antitubercular drugs isoniazid and rifampin, thereby shortening by 25 percent the time required to cure mice of experimental TB.

SQ109 could replace one or more of the current first-line TB drugs if approved. The drug was developed in partnership with the NIH.