Spero Therapeutics,  a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments for multidrug-resistant (MDR) bacterial infections has 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 (NTM) infections. 

“SPR720 is a promising drug candidate that has the potential to become the first approved oral treatment for NTM infections. NTM infections cause chronic, debilitating disease and represent an area of high unmet need as there are no specifically approved orally administered treatment options,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “We look forward to receiving top-line results from the Phase 1 trial assessing the safety, tolerability and pharmacokinetics of SPR720 in the second half of 2019.”

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 (absorption, distribution, metabolism and excretion) 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.