Jan 6 2009
Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today that SQ109, its lead drug candidate for the treatment of tuberculosis (TB), was the first drug approved for evaluation in a newly awarded clinical program contract to Dynport Vaccine Company LLC and Quintiles Transnational.
The contract, awarded by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), is part of NIAID's clinical resource infrastructure to accelerate Phase 1 studies of promising clinical stage drugs or vaccines that address emerging and re-emerging infectious tropical diseases and bioweapon pathogens. The Phase 1B clinical study of SQ109 should be initiated in Q1 2009.
SQ-109 is a new diamine antibiotic intended to replace one or more of the current first-line anti-TB drugs and simplify patient therapy. SQ109 was granted U.S. FDA Fast Track designation and FDA/EMEA Orphan Drug Designation in 2007. SQ109 shows activity against drug sensitive and multi-drug resistant (MDR and XDR) Mycobacterium tuberculosis, the causative agent of TB. The Phase 1B study will assess safety and pharmacokinetics of multiple doses of SQ109 in healthy subjects.
"This is absolutely the best of both worlds for Sequella," commented Dr. Carol Nacy, Sequella CEO. "We again successfully competed for support from our most valued funding partner, NIAID, while retaining the capacity to work with the same industry-leading contract research organization, Quintiles Transnational, that conducted our first-in-human Phase 1A trial for SQ109.
The trial will be conducted at the Overland Park Quintiles Transnational Phase 1 facility in Lenexa, Kansas.
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