Spero Therapeutics, Inc. Announces Initiation of SPR720 Phase 1 Clinical Trial
January 29, 2019 at 08:00 am EST
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Spero Therapeutics, Inc. announced that it has initiated a Phase 1 clinical trial of SPR720, an orally administered antimicrobial agent being developed for the treatment of non-tuberculous mycobacterial infections. The Phase 1 clinical trial evaluating SPR720 is a double-blind, placebo-controlled, ascending dose, multi-cohort study in healthy subjects consisting of single ascending dose and multiple ascending dose cohorts. The advancement of SPR720 into the Phase 1 clinical assessment was based on SPR720’s favorable profile exhibited in a suite of pre-clinical in vitro and in vivo safety, toxicology and ADME studies, as well as SPR720’s demonstration of potent in vitro and in vivo activity versus multiple, clinically important species of NTM, including Mycobacterium avium complex and Mycobacterium abscessus. The collective pre-clinical data to date suggest that SPR720 has an acceptable safety profile, encouraging target pathogen efficacy, drug distribution to key sites of infection, such as the lung, and a wide therapeutic margin. Spero expects to receive top-line data from the Phase 1 clinical trial in the second half of 2019.
Spero Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections with unmet need. Its lead product candidate, SPR720, is an oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease, a rare orphan disease. Its partnership-directed programs consist of tebipenem HBr and SPR206. The tebipenem HBr is designed to be the oral carbapenem-class antibiotic for use to treat certain bacterial infections that cause complicated urinary tract infections (cUTIs), including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options. SPR206 is a direct acting intravenous (IV)-administered product candidate being developed as an option to treat MDR Gram-negative bacterial infections in the hospital setting.
SPERO THERAPEUTICS, INC. 
