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

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.