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Spero Reports Preliminary Findings from Phase 1 Clinical Trial of SPR206 and Plans to Advance Program with Alliance Partners Everest Medicines and the Department of Defense
First indication of human safety and pharmacokinetic profiles for SPR206 supports advancement of program to clinical pharmacology studies planned to initiate
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"First indication of human safety and pharmacokinetic profiles for SPR206 supports advancement of program to clinical pharmacology studies planned to initiate in the second half of 2020\nCAMBRIDGE, Mass., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections and rare diseases, today announced preliminary findings from its Phase 1 first-in-humans clinical trial of SPR206, an IV-administered product candidate being developed by Spero as an innovative option to treat MDR Gram-negative bacterial infections. \n Analysis of preliminary, blinded data from the Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy adult volunteers suggests that SPR206 is well-tolerated at doses that are likely to be within a therapeutic range for target MDR Gram-negative bacterial infections and has a safety profile that Spero believes supports the further development of SPR206. The decision to continue development of SPR206 is also supported by data from nonclinical studies in which SPR206 demonstrated activity as a single agent against MDR and extensively drug resistant (XDR) bacterial strains, including isolates of Pseudomonas aeruginosa, Acinetobacter baumannii and carbapenem-resistant Enterobacteriaceae, in both in vitro and in vivo models of infection. “We are encouraged by the preliminary safety, tolerability and pharmacokinetic data collected for SPR206 in healthy volunteers and look forward to continuing the development of this novel compound in conjunction with our partners,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “There exists an urgent need for safe and well-tolerated medicines with potent activity capable of treating the most serious Gram-negative infections experienced in the hospital setting. We believe SPR206 has the potential to meet this need and displace current sub-optimal options.” The Phase 1 clinical trial of SPR206 (Study SPR206-101) evaluated the safety, tolerability and pharmacokinetics of intravenously administered SPR206 at single doses ranging from 10 mg to 400 mg in seven SAD cohorts and repeat total daily doses ran...