Sequella Lead tuberculosis Drug SQ109 Completes Phase 1a Trial
Sequella announced the results of its SQ109 Phase 1a clinical trial.
This single center study was designed to assess the safety, tolerability, and pharmacokinetics of single oral doses of SQ109 administered to 62 healthy adult male and female subjects. SQ109 is a new, orally-active diamine antibiotic for the treatment of tuberculosis (TB) and other serious infectious diseases. The study found that doses of SQ109 up to 300 mg, the highest dose tested, were safe and well tolerated, with no serious adverse effects reported at any dose.
"We are very pleased with the Phase 1a results, as they confirm the importance of further clinical development of SQ109 to replace one or more of current first-line anti-TB drugs, simplify therapy, and shorten the treatment regimen for patients," said Dr. Carol A. Nacy. "As XDR-TB threatens the public health both here and abroad, we look forward to completing the clinical development of SQ109."
Oral administration of SQ109 produced measurable and dose-related plasma levels, with no drug-related changes in electrocardiograms, hematology, or serum chemistry values. In addition, plasma drug levels indicated that SQ109 was quickly and extensively distributed to tissues after oral ingestion, an observation also documented in preclinical studies.
"The amounts of SQ109 in the blood were similar to levels that were effective in treating animals infected with TB," said Dr. Gary Horwith, Chief Medical Officer for Sequella. "Furthermore, SQ109 appears to have a long half- life (61 hours), which suggests the drug would fit nicely into existing TB treatment regimens."
SQ109 has a mechanism of action molecularly distinct from other antibiotics used in TB therapy. It inhibits cell wall synthesis in a select group of microorganisms, with excellent in vitro activity against both drug susceptible and drug resistant TB bacteria, including XDR-TB. SQ109 also enhances, both in vitro and in vivo, the activity of the two front-line antitubercular drugs isoniazid and rifampin. Sequella plans to conduct an additional Phase 1b clinical study to demonstrate safety of daily administration of SQ109 alone, and then in combination with other TB drugs to evaluate safety and efficacy in patients with pulmonary TB. Additional clinical studies will begin Q2 2007.