Spero Therapeutics, a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant bacterial infections, announced data from the Company’s Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR741, the first product candidate from its Potentiator Platform. SPR741 is a novel investigational agent that in preclinical in vitro studies expanded the spectrum and increased the potency of more than two dozen antibacterial agents, including activity against common drug-resistant pathogens, such as E. coli and K. pneumoniae. In the Phase 1 study, SPR741 was well tolerated in single doses of up to 800 mg and at doses up to 600 mg every 8 hours for 14 days, the highest multiple dose tested in the study and above the dose expected to be assessed in an upcoming Phase 2 combination trial.
“We believe these encouraging results further confirm our understanding of the robustness of our Potentiator Platform and support the fundamental premise of SPR741 to expand antibacterial spectrum,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “There is an important need for new, clinically differentiated treatment options for Gram-negative infections in the hospital. The Potentiator Platform is a unique approach to this challenge that has the potential to allow physicians to make new and broader use of approved antibiotics to treat current and emerging drug resistant infections.”
The SPR741 Phase 1 SAD/MAD clinical trial was a two-part, randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending intravenous doses of SPR741. The study enrolled 96 healthy adult volunteers in cohorts up to 800 mg single dose and 600 mg dose every 8 hours for 14 days.
Filed Under: Drug Discovery
