FDA Grants QIDP Designation to SPR720 for NTM Infections

The US Food and Drug Administration (FDA) has granted a Qualified Infectious Disease Product (QIDP) designation to SPR720, an oral agent being developed to treat lung infections caused by non-tuberculous mycobacteria (NTM) and lung infections caused by Mycobacterium tuberculosis.

SPR720 is being developed by Spero Therapeutics and is currently being assessed in a phase 1 clinical trial that is a double-blind, placebo-controlled study designed to analyze the safety, tolerability, and pharmacokinetics of the investigative agent.

Currently, there are currently no oral antibiotics specifically approved for use to treat pulmonary NTM infections. The available options for treatment of pulmonary NTM infections feature prolonged therapy with a combination regimen, which leaves patients vulnerable to complications because of tolerability and/or toxicity issues.

“We are pleased that the FDA has acknowledged the promise of SPR720 for the treatment of NTM and TB, by granting QIDP status for the compound,” Ankit Mahadevia, MD, chief executive officer of Spero Therapeutics, said in making the announcement. “SPR720 has the potential to become the first approved oral treatment for NTM infections, an area of high unmet need that requires prolonged therapy and where no specifically approved orally administered treatments exist.”

According to the company, the investigational agent is representative of a novel class of antibacterial agents which are designed to target enzymes that are critical for bacterial DNA replication.

In pre-clinical in vitro and in vivo studies, SPR720 has been evaluated against a range of bacteria that cause TB and pulmonary NTM infections, including Mycobacterium avium complex and Mycobacterium abscessus, which is notably highly resistant and associated with high mortality.

The data from pre-clinical studies thus far indicates that SPR720 has “an acceptable safety profile,” and has demonstrated “encouraging activity” against the target NTM and tuberculosis pathogens.

Under the QIDP designation, SPR720 will receive an additional 5-year extension of Hatch-Waxman Act exclusivity, as well as priority FDA review of the first marketing application or efficacy supplement, and the indication for which QIDP designation was granted, and the opportunity to request Fast Track designation.

Spero reports that top-line data from the phase 1 clinical trial is anticipated in the second half of 2019. Additionally, the company notes that research on SPR720 was partially supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.