Sequella said today it acquired exclusive worldwide rights from Pfizer to develop and commercialize sutezolid, an oxazolidinone antibiotic currently in Phase II clinical development to treat tuberculosis (TB). The value of those rights was not disclosed. Sequella will be solely responsible for completing clinical development and commercializing the product globally.
Sutezolid showed promise in a Phase IIa Early Bactericidal Activity EBA study in TB patients in South Africa, and earlier demonstrated potent antibacterial activity against Mycobacterium tuberculosis in preclinical lab studies and animal models of TB.
“We are delighted to bring in a second clinical-phase TB asset that may be paired with other TB drugs or with SQ109,” Carol A. Nacy, Ph.D., Sequella’s co-founder, CEO, and chairman, said in a statement. SQ109 is Sequella’s lead product candidate, a small molecule antibiotic now in a Phase III trial for multi-drug resistant TB in Russia, as well as Phase II studies for drug-sensitive TB in Africa. SQ109 is also in clinical trials for gastritis (Helicobacter pylori infections).
“We will pursue development of sutezolid under its own NDA, and also plan for combination studies in subsequent clinical trials,” Dr. Nacy added.
Rod MacKenzie, Ph.D., group svp and head of pharmatherapeutics R&D at Pfizer, said in the statement the pharma giant sold rights to sutezolid after refocusing its internal infectious disease R&D from developing treatments to preventive vaccines.
“Given the urgent patient need in TB, we sought a partner for sutezolid that would bring deep expertise and a strong commitment to TB patients. We believe Sequella meets these criteria and offers a portfolio with the important potential for combination studies,” Dr. MacKenzie said.
Sequella’s portfolio includes SQ609, a dipiperidine or antibiotic compound in preclinical toxicology and pharmacology tests; and capuramycin analogs, a class of semi-synthetic, nucleoside-based compounds against target bacteria that enhance the effectiveness of antibiotics in preventing the development of drug-resistant mutants in vitro.
Preclinical laboratory studies performed separately by both Sequella and Pfizer have shown SQ109 and sutezolid to show some activity against TB as single agents, and promising additional activity when used in combination. The companies reason that a regimen containing SQ109 and sutezolid could potentially improve the efficacy and containment of resistance shown by existing therapies given the low natural resistance rate of M. tuberculosis to either drug, their shortening of treatment time in animal TB models, and their distinct and complementary mechanisms of action on M. tuberculosis.