Benzinga | Jan 4, 2022 08:06AM EST

Spero Therapeutics Reports FDA Clinical Hold On SPR720 Lifted

Spero Therapeutics, Inc. (NASDAQ:SPRO), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 2 trial of SPR720, Spero's investigational oral product candidate being developed for nontuberculous mycobacterial (NTM) disease.

"We are very pleased with the FDA's decision and eager to bring SPR720 back into the clinic," said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. "Extensive analyses, together with prior clinical and non-clinical data, support our belief that SPR720 has the potential to offer a new, well-tolerated, oral treatment option for patients suffering from NTM-PD. We would like to thank the FDA for its guidance and look forward to SPR720's continued clinical development."

David Melnick, M.D., Chief Medical Officer of Spero, added, "Current treatments for nontuberculous mycobacteria are often ineffective and involve lengthy and complex combination regimens that include injectable and/or inhalable antibiotics. Through SPR720's clinical development and potential future marketing approval, we aim to provide appropriate NTM-PD patients with a once-daily oral therapy, in conjunction with existing therapeutic regimens. This has the potential to address a pressing unmet need for an indication that represents a global health concern with increasing incidence."

The SPR720 program was placed on a clinical hold by the FDA following a review of data from a non-human primate (NHP) toxicology study in which mortalities with inconclusive causality to treatment were observed. The FDA's decision to lift the hold follows Spero's submission of a comprehensive study report with detailed analyses from the NHP toxicology study. Spero plans on engaging with the FDA in Q1 of 2022 to discuss the re-initiation of the SPR720 Phase 2 trial for NTM-pulmonary disease (NTM-PD) patients, with an expected study start date commencing in the second half of 2022.