FDA Lifts 11-Month Hold on Spero's Lung Disease Drug

FDA_Sarah Silbiger/Getty Images

Sarah Silbiger/Getty Images

On Tuesday, Spero Therapeutics announced the U.S. Food and Drug Administration (FDA) had lifted the clinical hold made by the agency on February 2021 for its Phase IIa trial of SPR720. The drug is an oral antimicrobial agent being studied in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).

The clinical hold came after the FDA reviewed data from a non-human primate (NHP) toxicology study. In the data, they found deaths with “inconclusive causality to treatment.” They decided to lift the hold after Spero submitted a comprehensive analysis from the NHP toxicology study. 

“We are very pleased with the FDA’s decision and eager to bring SPR720 back into the clinic,” said Dr. Ankit Mahadevia, Chief Executive Officer of Spero. “Extensive analyses, together with prior clinical and non-clinical data, support our belief that SPR720 has the potential to offer a new, well-tolerated, oral treatment option for patients suffering from NTM-PD. We would like to thank the FDA for its guidance and look forward to SPR720’s continued clinical development.”

SPR720 is from a novel class of antibacterial agents. They target enzymes required for bacterial DNA replication. Nontuberculous mycobacterial disease is a rare orphan disease. 

Nontuberculous mycobacteria are found everywhere and can cause progressive lung damage and respiratory failure, especially if people are immunocompromised or have underlying pulmonary disease. Treatment currently requires continuous therapy for 12 to 24 months with a combination of largely unapproved drugs. This treatment often runs into problems with tolerability and toxicity. There are currently no oral antibiotics approved to treat pulmonary NTM disease.

The FDA has granted the drug Qualified Infectious Disease Product (QIDP) designation for the treatment of lung infections caused by nontuberculous mycobacteria and for lung infections from Mycobacterium tuberculosis (Mtb). The FDA also gave it an orphan drug designation for NTM infection. The agency also designated Fast Track status for the study of SPR720 capsules for adults with NTM-PD.

Dr. David Melnick, Spero’s Chief Medical Officer, said, “Current treatments for nontuberculous mycobacteria are often ineffective and involve lengthy and complex combination regimens that include injectable and/or inhalable antibiotics. Through SPR720’s clinical development and potential future marketing approval, we aim to provide appropriate NTM-PD patients with a once-daily oral therapy, in conjunction with existing therapeutic regimens. This has the potential to address a pressing unmet need for an indication that represents a global health concern with increasing incidence.”

On January 3, 2022, the FDA granted the company Priority Review and confirmed the acceptance of its New Drug Application (NDA) for tebipenem HBr oral tablets for adults with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible microorganisms. The drug has also been granted QIDP, Fast Track and Priority Review. The FDA has scheduled an Advisory Committee meeting and set a PDUFA data of June 27, 2022.

“The FDA acceptance of this NDA is a major step forward in our mission to provide patients the first and only oral carbapenem antibiotic to treat cUTI,” said Dr. Mahadevia. “If approved, tebipenem HBr may provide patients an oral treatment option, allowing them to potentially either recover at home from their infections or leave the hospital sooner. This is an important accomplishment and an exciting moment for all of us at Spero, as we execute our plan on becoming a commercial organization. We are committed to working closely with the FDA throughout the NDA review process and look forward to tebipenem HBr’s anticipated launch in the second half of 2022."

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