Favorable Pharmacokinetic and Safety Data for SPR741 Observed at Doses Exceeding the Anticipated Phase 2 Dose Range
CAMBRIDGE, Mass., Oct. 03, 2017 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc., a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant bacterial infections, today 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.
Spero Therapeutics is a multi-asset, clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multi-drug resistant (MDR) bacterial infections.
Spero is advancing SPR994, which is designed to be the first broad-spectrum oral antibiotic for use in adults to treat MDR Gram-negative infections.
Spero is also advancing its Potentiator Platform, which it believes will enable it to develop drugs that will expand the spectrum and potency of existing antibiotics, including formerly inactive antibiotics, against Gram-negative bacteria. SPR741, Spero’s lead potentiator product candidate, is a clinical-stage, IV-administered agent that has been observed in in vitro studies to potentiate over two dozen existing antibiotics by expanding their activity against Gram-negative pathogens. SPR206, Spero’s preclinical potentiator product candidate, is also designed to have antibiotic activity as a single agent against certain MDR and extremely drug resistant (XDR) bacterial strains.
Spero is also developing SPR720, its novel oral therapy product candidate designed for the treatment of pulmonary non-tuberculous mycobacterial (NTM) infections.
For more information, please visit https://sperotherapeutics.com.
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