Spero Therapeutics Announces Clearance of IND for SPR206 to Treat MDR Gram-negative Bacterial Infections - Seite 2

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
Select SPR206 studies have been supported by the Office of the Assistant Secretary of Defense for Health Affairs, through the Joint Warfighter Medical Research Program under Award No. W81XWH 19 1 0295. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

National Institute of Allergy and Infectious Disease
Select SPR206 studies have been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N93021C00022. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Government Agency Research Support
The views expressed in this press release are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, Department of Health and Human Services or the U.S. Government.

About Spero Therapeutics, Inc.
Spero Therapeutics, Inc., (Spero) headquartered in Cambridge, Massachusetts, is a multi-asset, clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for bacterial infections, including multi-drug resistant bacterial infections and rare diseases.