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Spero Therapeutics Receives FDA Orphan Drug Designation for SPR720 for the Treatment of Nontuberculous Mycobacterial (NTM) Infection
CAMBRIDGE, Mass., March 11, 2020 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq:SPRO), a multi-asset clinical-stage biopharmaceutical company focused on
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., March 11, 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 bacterial infections and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for oral SPR720 for the treatment of nontuberculous mycobacterial (NTM) infection.\n “We are happy to receive this important designation from the FDA, which highlights the critical unmet need that SPR720 is being developed to address,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “We look forward to our continued work with the FDA to advance SPR720 for a population of patients suffering from NTM pulmonary disease in need of novel treatments.” In December 2019, Spero announced positive preliminary data from its Phase 1 clinical trial of SPR720, which was designed as a double-blind, placebo-controlled clinical trial to assess the safety, tolerability and pharmacokinetics (PK) of SPR720 at single and multiple ascending doses in healthy volunteers. These results indicated that SPR720 in healthy volunteers was generally well-tolerated at doses up to 1000 mg over the maximum studied duration of 14 days, with a PK profile that Spero believes supports SPR720’s further development as an oral agent for the treatment of NTM pulmonary disease. Spero expects to present final data from the SPR720 Phase 1 clinical trial at a medical conference during 2020. Spero plans to meet with the FDA in the first half of 2020, submit an investigational new drug (IND) application for SPR720 to the FDA in the second half of 2020 and, subject to FDA acceptance of the IND, initiate a dose-ranging Phase 2a clinical trial evaluating SPR720 in patients with NTM pulmonary disease due to Mycobacterium avium complex (MAC) in the second half of 2020. The FDA’s Office of Orphan Products Development (OOPD) grants orphan designation status to a drug that is intended to treat a rare disease or condition that affects fewer than 200,000 persons in the United States. Orphan drug designation provides certain benefits and incentives that may include tax credits towards the cost of clinical trials and prescription drug user fee waivers and the potential for seven...