Benzinga | Aug 31, 2020 08:00AM EDT

Spero Therapeutics Announces FDA Acceptance Of IND Application for SPR720

CAMBRIDGE, Mass., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (NASDAQ:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on identifying, developing and commercializing treatments in high unmet need areas involving multi-drug resistant (MDR) bacterial infections, today announced the acceptance by the U.S. Food and Drug Administration (FDA) of Spero's Investigational New Drug application (IND) for SPR720, Spero's oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. With the IND now accepted, Spero plans to initiate enrollment in its planned Phase 2a clinical trial evaluating SPR720 in patients with NTM pulmonary disease by year-end 2020.

"The FDA acceptance of the IND for SPR720 represents another important milestone for this program and we look forward to initiating the Phase 2a clinical trial later this year, our first trial in patients with NTM," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero Therapeutics. "A critical unmet need exists for patients with NTM pulmonary disease and we believe that SPR720, as a novel oral agent under investigation, has the potential to change the treatment paradigm and provide new treatment options for patients."

The planned Phase 2a clinical trial will be a multi-center, partially blinded, placebo-controlled proof-of-concept clinical trial of SPR720 that will enroll approximately 90 treatment inexperienced patients with NTM pulmonary disease due to Mycobacterium avium complex (MAC). Patients will be randomized to receive either 500mg or 1,000mg of oral SPR720, placebo or standard of care consisting of a macrolide and ethambutol, plus the option of adding a rifamycin. The objectives of the trial are to evaluate plasma pharmacokinetics, safety, tolerability, and microbiological response of SPR720 compared with placebo and standard of care over 28 days of treatment.