FDA grants IND clearance to Spero Therapeutics’ bacterial infection treatment

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 studythatwillassessthesafety,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 licence agreement with Pfizer, which was made along with Pfizer’s $40m equity investment in Spero, announced in June 2021. According to the press release,
‘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’.
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.”