Anti-Fungal, Additional Mycobacterial Indications Among Those Targeted
ROCKVILLE, Md., Nov. 16 /PRNewswire/ -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat life-threatening infectious diseases, today announced that it amended an existing agreement with the National Institutes of Health (NIH) to significantly broaden the licensed therapeutic indications, or "field of use," for Sequella's lead drug candidate, SQ109.
SQ109, currently completing a Phase IB safety study in humans under its original tuberculosis IND, is a new chemical entity with broad antibiotic potential. It was co-discovered by scientists at Sequella and at the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under an earlier Cooperative Research and Development Agreement. Sequella previously negotiated from NIH worldwide exclusive rights for SQ109's use against tuberculosis.
The new agreement will allow Sequella to pursue additional infectious disease indications targeting fungi and a variety of nontubercular Mycobacteria.
Dr. Carol Nacy, CEO of Sequella, said, "We see tremendous promise in the future of SQ109, both as part of a new tuberculosis regimen and as a therapeutic active against other infectious agents. IND-directed studies in support of these new indications are underway."
SQ109 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. SQ109 is due to begin a Phase 1B study to assess safety and pharmacokinetics of multiple doses of SQ109 in healthy subjects.
|SOURCE Sequella, Inc.|
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