ROCKVILLE, Md., May 5 /PRNewswire/ -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on diseases of epidemic potential, announced today the start of its Phase 1B trial for SQ109 with the dosing of the first cohort of volunteers. SQ109, a new diamine antibiotic intended to replace one or more of the current first-line antitubercular drugs and simplify patient therapy, was granted U.S. FDA Fast Track designation and FDA/EMEA Orphan Drug Designation in 2007. SQ109 shows superior antibacterial activity against drug sensitive and both multi-drug resistant and extensively-drug resistant (MDR and XDR) Mycobacterium tuberculosis, the causative agent of tuberculosis (TB). The Phase 1B study will assess safety, pharmacokinetics and tolerability of multiple ascending doses of SQ109 in three cohorts of healthy volunteers.
"We are pleased to begin this Phase 1B safety trial and to continue the clinical development of SQ109, a potentially valuable new drug candidate for the treatment of both uncomplicated and drug resistant TB," said Dr. Carol Nacy, Sequella CEO. "With the growing number of new TB cases within HIV-infected populations, there is no time to waste. Clinicians and patients alike are desperate for new drugs to shorten treatment times and improve patient outcomes. In a global world, the safety assessment of a new drug candidate with the antitubercular properties of SQ109 is an important milestone for patients on every continent, including North America."
The SQ109 Phase 1B trial is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), through a contract awarded to Dynport Corporation. The investigative site is the Quintiles Phase 1 facility in Overland Park, Kansas.
Sequella is a clinical stage biopharmaceutical company focused on commercializing improved treatments for diseases of epidemic potential. The company leverages its global influence, R&D platforms and infectious disease expertise to proactively address emerging health threats. Through focused execution, clear commercialization pathways, and strategic partnerships, Sequella intends to commercialize a broad product portfolio designed to treat global health threats with significant market opportunity.
About the NIH and NIAID
The NIH -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov. NIAID conducts and supports research -- at NIH, throughout the United States, and worldwide -- to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law.
|SOURCE Sequella, Inc.|
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