Spero Therapeutics has commenced a Phase I clinical trial to evaluate SPR720 for the treatment of non-tuberculous mycobacterial (NTM) infections.
SPR720 is a type of orally administered antibacterial agent that targets enzymes required for bacterial DNA replication.
The trial features a double-blind, placebo-controlled, ascending dose, multi-cohort design. It is expected to enrol healthy subjects in single and multiple ascending dose cohorts.
Top-line data from the trial is expected to be available in the second half of this year.
Spero Therapeutics CEO Ankit Mahadevia said: “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.
“We look forward to receiving top-line results from the Phase I trial assessing the safety, tolerability and pharmacokinetics of SPR720 in the second half of 2019.”
The Phase I trial is based on positive results involving SPR720 in a set of pre-clinical in vitro and in vivo safety, toxicology, and absorption, distribution, metabolism and excretion (ADME) studies.
It is also based on the positive demonstration of SPR720’s vitro and in vivo activity over multiple, clinically important species of NTM, including mycobacterium avium complex and mycobacterium abscessus.
Pre-clinical data showed that SPR720 features a satisfactory safety profile to promote target pathogen efficacy, drug distribution to key sites of infection, such as the lung and various therapeutic margin.