FDA Approves Phase 2 Trial for Spero's SPR206 Against MDR Infections

Spero Therapeutics, a clinical-stage biopharmaceutical firm, has been granted approval by the U.S. FDA to proceed with a Phase 2 study of its drug candidate, SPR206. This new-generation polymyxin antibiotic is designed to treat hospital-acquired and ventilator-associated pneumonia caused by multi-drug resistant (MDR) Gram-negative bacteria.

The Phase 2 trial aims to assess the safety, efficacy, and pharmacokinetics of SPR206 when combined with other antibiotics for treating patients with pneumonia caused by specific MDR bacteria. The study is expected to enroll around 60 hospitalized adults, who will be treated for 7 to 14 days and monitored for post-treatment outcomes.

Kamal Hamed, Chief Medical Officer at Spero, emphasized the significance of this milestone, highlighting the serious nature of the infections targeted by SPR206 and the challenges posed by MDR pathogens. The company believes that if approved, SPR206 could offer a valuable therapeutic option for clinicians.

SPR206 operates by interacting directly with the bacterial outer membrane to combat Gram-negative infections. Preclinical studies have shown its broad-spectrum potency against such bacteria, including those classified as urgent threats by health organizations. Phase 1 trials have demonstrated the drug's good tolerability and lack of nephrotoxicity at therapeutic doses.

The drug is part of a licensing agreement with Pfizer, which includes rights for Pfizer to develop, manufacture, and commercialize SPR206 outside the U.S. and Asia, with Spero eligible to receive payments and royalties based on development and sales milestones.

The development of SPR206 has been supported by various entities, including the Department of Defense and the National Institute of Allergy and Infectious Diseases, emphasizing the importance of addressing MDR bacterial infections.

Spero Therapeutics, based in Cambridge, Massachusetts, is dedicated to developing innovative treatments for bacterial infections and rare diseases. The company's pipeline includes SPR720 for a rare pulmonary disease and tebipenem pivoxil HBr for complicated urinary tract infections, with SPR206 being a key focus in the hospital setting due to its potential against MDR infections.

The company's mission is underscored by its commitment to advancing treatments that address significant unmet medical needs, with SPR206 representing a promising step forward in the fight against resistant bacterial strains.