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Spero Therapeutics Announces Clearance of IND for SPR206 to Treat MDR Gram-negative Bacterial Infections | ||
By: GlobeNewswire - 28 Feb 2024 | Back to overview list |
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CAMBRIDGE, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying and developing novel treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that it has received clearance by the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application, to evaluate SPR206 in a Phase 2 clinical study. SPR206 is a novel, intravenously (IV) administered next-generation polymyxin antibiotic for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by MDR Gram-negative bacterial infections. "Clearance of this IND is an important milestone in our SPR206 development program, as we prepare to advance this drug candidate into a Phase 2 trial in HABP/VABP," said Kamal Hamed, Spero’s Chief Medical Officer. "HABP/VABP are serious infections associated with high mortality and substantial morbidity, and their management has been complicated by the increasing prevalence of difficult-to-treat and MDR Gram-negative pathogens. SPR206 is being developed to address this unmet need, and if approved, we believe it could provide clinicians with a valuable new therapeutic option." The planned Phase 2 study will be a randomized, double-blinded, controlled, multicenter study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of SPR206 in combination with select antibiotics for the treatment of patients diagnosed with HABP or VABP, caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex or carbapenem-resistant Pseudomonas aeruginosa. Approximately 60 adult hospitalized patients are expected to be enrolled. Patients will receive treatment for 7?14 days and will be evaluated through assessment of post-baseline clinical outcomes. SPR206 is subject to a license agreement with Pfizer Inc., which was made alongside Pfizer’s $40 million equity investment in Spero, previously announced in June 2021. Pursuant to the license agreement, Pfizer was granted the rights to develop, manufacture, and commercialize SPR206 in ex-U.S. and ex-Asia territories. In exchange for these rights, Spero is eligible to receive up to $80 million in development and sales milestones, and high single digit to low double-digit royalties on net sales of SPR206 in these territories. About SPR 206 SPR206 is an IV-administered next-generation polymyxin product candidate designed to act directly on Gram-negative bacterial infections through the molecule’s interactions with the bacterial outer membrane. In preclinical studies, SPR206 has demonstrated potent broad-spectrum activity against Gram-negative bacteria, including organisms identified by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) as urgent and serious threats to human health. Spero completed a first-in-human Phase 1 assessment of SPR206 in which the product candidate was generally well tolerated and demonstrated no evidence of nephrotoxicity at anticipated therapeutic doses. Two other Phase 1 studies, a bronchoalveolar lavage (BAL) clinical trial assessing the intrapulmonary pharmacokinetics of SPR206 and a renal impairment clinical trial, were also completed. For more information on these trials and their designs, see ClinicalTrials.gov identifiers NCT03792308 (first-in-human trial), NCT04868292 (BAL trial) and NCT04865393 (renal impairment trial). SPR206 has been granted Qualified Infectious Disease Product (QIDP) designation by the United States FDA for the treatment of complicated urinary tract infections and HABP/VABP. Department of Defense National Institute of Allergy and Infectious Disease Government Agency Research Support About Spero Therapeutics, Inc.
For more information, visit www.sperotherapeutics.com Forward-Looking Statements Investor Relations Contact: Media Inquiries: |
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