Spero Therapeutics Receives QIDP Designation from the U.S. FDA for the Development of SPR720

Spero Therapeutics (NASDAQ:SPRO) has announced that SPR720 has been granted qualified infectious disease product (QIDP) designation from the US Food and Drug Administration (FDA) to treat lung infections.

As quoted in the press release:

“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,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “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.”

The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act and creates incentives for the development of certain antibiotics that treat serious or life-threatening infections. The primary incentives are an additional five-year extension of Hatch-Waxman Act exclusivity, as well as priority FDA review of the first marketing application or efficacy supplement for SPR720 and the indication for which QIDP designation was granted, and the opportunity to request Fast Track designation for SPR720.

SPR720 is currently being evaluated in a Phase 1 double-blind, placebo-controlled clinical trial designed to assess the safety, tolerability and pharmacokinetics of SPR720 in healthy volunteers. The advancement of SPR720 into this first-in-human clinical trial was based on cumulative data from pre-clinical safety, toxicology and ADME (absorption, distribution, metabolism and excretion) studies as well as nonclinical efficacy studies demonstrating potent activity for SPR270 in vitro and in vivo against TB and clinically important NTM species, including Mycobacterium avium complex and Mycobacterium abscessus.  The collective pre-clinical data to date suggest that SPR720 has an acceptable safety profile, with encouraging activity against the target NTM and TB pathogens, 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.

Click here to read the full press release.