Spero Therapeutics’ bacterial infection treatment gains FDA IND clearance
Betsy Goodfellow | February 29, 2024 | News story | Medical Communications | FDA, Infections and infestations, Spero Therapeutics, bacterial infections, investigational new drug
Spero Therapeutics has announced that it has gained US Food and Drug Administration (FDA) clearance for the investigational new drug (IND) application to assess SPR206 in a phase 2 clinical study.
The candidate is a novel, intravenously (IV) administered next-generation polymyxin antibiotic intended to be used for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by multi-drug resistant (MDR) Gram-negative bacterial infections.
The trial is planned to be a randomised, double-blinded, controlled, multicentre study which will assess the safety, tolerability, efficacy and pharmacokinetics of SPR206 in combination with certain other antibiotics for the treatment of patients with HABP or VABP.
The candidate is subject to a license agreement with Pfizer, which was made along with Pfizer’s $40m equity investment in Spero, announced in June 2021.
Kamal Hamed, Spero Therapeutics’ chief medical officer, commented: “Clearance of this IND is an important milestone in our SPR206 development programme, as we prepare to advance this drug candidate into a phase 2 trial in HABP/VABP. 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.”
Betsy Goodfellow
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