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     104  0 Kommentare Spero Reports Preliminary Findings from Phase 1 Clinical Trial of SPR720 and Announces Plans to Advance Program into Proof-of-Concept Clinical Trial in Patients with NTM Pulmonary Disease

    First indication of human safety and PK profiles for SPR720 supports advancement of program to a Phase 2a proof-of-concept clinical trial in patients planned to initiate in the second half of 2020

    CAMBRIDGE, Mass., Dec. 04, 2019 (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 and rare diseases, today announced preliminary findings from a Phase 1 first-in-human clinical trial of SPR720, its oral antimicrobial agent in development for the treatment of nontuberculous mycobacterial (NTM) pulmonary disease. Analysis of blinded data from the Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy volunteers suggests that SPR720 is generally well-tolerated, with a pharmacokinetic (PK) profile that Spero believes supports the further development of SPR720 as an oral agent for the treatment of NTM pulmonary disease. Spero plans to submit an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) and initiate a Phase 2a clinical trial of SPR720 in patients with NTM pulmonary disease during the second half of 2020.

    “We are encouraged by the preliminary safety, tolerability and PK data collected for SPR720 in healthy volunteers,” said Ankit Mahadevia, M.D., CEO of Spero Therapeutics. “In the absence of any oral antibiotic approved by the FDA for the treatment of NTM pulmonary disease, SPR720 has the potential to significantly change the treatment paradigm for this chronic, debilitating disease for which there are currently limited treatment options.  The nature of these data gives us confidence in selecting doses for our planned Phase 2a dose-ranging clinical trial, which we plan to initiate in the second half of 2020.”  

    The Phase 1 clinical trial of SPR720 (SPR720-101) evaluated the safety, tolerability and PK of orally administered SPR720 at single doses ranging from 100 mg to 2000 mg and repeat total daily doses ranging from 500 mg to 1500 mg for up to 7 to 14 days. Across seven SAD and five MAD cohorts, a total of 96 healthy volunteers (including a cohort of healthy elderly (age ≥ 65 years) volunteers) were randomized to receive SPR720 or placebo. There were no serious adverse events reported and all participants completed the trial. Although the data remain blinded, an analysis of preliminary data indicates that SPR720 was generally well-tolerated at doses up to 1000 mg over the maximum studied duration of 14 days. Preliminary analyses of PK data across the cohorts show no significant impact of either advanced age or administration with food on PK variables. At doses of 500 mg or higher, the mean plasma drug exposures of SPR719, the active metabolite of SPR720, are consistent with those suggested by in vitro and in vivo models of SPR720 to be necessary for clinical efficacy against target NTM pathogens.

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    Spero Reports Preliminary Findings from Phase 1 Clinical Trial of SPR720 and Announces Plans to Advance Program into Proof-of-Concept Clinical Trial in Patients with NTM Pulmonary Disease First indication of human safety and PK profiles for SPR720 supports advancement of program to a Phase 2a proof-of-concept clinical trial in patients planned to initiate in the second half of 2020CAMBRIDGE, Mass., Dec. 04, 2019 (GLOBE NEWSWIRE) - …

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