Spero Therapeutics is developing SPR720, a novel, investigational oral agent to treat NTM pulmonary disease.
SPR720 is an orally administered investigational antibacterial agent being developed for the treatment of NTM pulmonary disease. If approved, SPR720 will represent a novel class of antibacterial agents that target enzymes essential for bacterial DNA replication.
The clinical development of SPR720 is supported by data from its first-in-human Phase 1 clinical trial of SPR720 in healthy volunteers and pharmacokinetic / pharmacodynamic data that suggested predicted therapeutic exposures could be attained with a 500 – 1,000 mg once daily oral dose. Pre-clinical in vitro and in vivo studies have demonstrated potency for SPR720 against Mycobacterium tuberculosis (TB) and a range of bacteria that cause NTM infections, including mycobacterium avium complex, mycobacterium kansasii and mycobacterium abscessus.
Designed to improve lives of patients suffering from NTM
SPR720 may fill an urgent void for a new suite of drugs that can be used in combination to arrest NTM infection, and possibly prevent the lung damage that infection causes.
August 11, 2022 - SPR720 posted to ClincialTrials.gov with an estimated start to begin in November 2022.
In February 2021, 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. In January 2022, the FDA made the decision to lift the clinical hold following Spero’s submission of a comprehensive study report with detailed analyses from the NHP toxicology study. Spero engaged 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 Phase 2 study start date commencing in the fourth quarter of 2022
There is a growing population of older NTM patients, some of them have underlying immunosuppressive disease or chronic progressive pulmonary disease, without adequate treatment. This is a huge clinical void right now. There’s nothing in that space, and patients are desperate for new treatment.
Chief Development Officer
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Patients can follow the progress of SPR720 as the candidate moves through clinical trials. ClinicalTrials.gov is a database of clinical studies conducted worldwide.
(Blog post authored by Ankit Mahadevia)