Spero Therapeutics, a multi-asset, clinical-stage biopharmaceutical company, announced it is laying off 75% of its staff.
The move comes after Spero said it will defer commercialization activities of its urinary trace infection treatment, tebipenem HBr. The company is also restructuring its operations to reduce operating costs and reallocate assets toward other drugs. Spero made the decision after a late cycle meeting with the Food and Drug Administration (FDA) regarding the company’s application for the drug.
Despite an ongoing review of the drug, the meeting led Spero to believe the FDA will not approve it in this review cycle.
“We are disappointed that the FDA has identified substantive review issues, and we strongly believe that tebipenem HBr would offer healthcare providers, payers and patients an important oral antibiotic alternative to IV treatment for cUTI for patients with limited oral treatment options,” Ankit Mahadevia, MD, CEO of Spero Therapeutics, said in a statement.
The company’s stock tanked immediately following the announcement, shedding nearly 70% of its value, according to Market Watch. Spero said it will continue to engage with the FDA on the appropriate path forward for tebipenem HBr, which is used for drug-resistant UTI treatment. The biotech company will focus its resources on the clinical development programs of SPR720 and SPR206.
“While this decision was difficult, we believe it is in the best interest of the company and its shareholders,” Mahadevia said. “The need for antibiotic resistance solutions is more pressing than ever before, and both SPR720 and SPR206 are in clinical development stages and have shown promising results to date. SPR720’s Phase 2 clinical hold was recently lifted, enabling its continued development as an oral therapy for non-tuberculosis mycobacterial infection, a debilitating, chronic disease. We are also very pleased with the ongoing development of SPR206 as a treatment for MDR gram-negative lung infections.”
Tebipenem HBr has been granted Qualified Infectious Disease Product (QIDP), Fast Track and Priority Review designations for treatment of complicated urinary tract infection (cUTI), including acute pyelonephritis.
The layoffs also come after Spero raised $12.9 million earlier this year from the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services. The funding expanded on the existing partnership to develop tebipenem as a treatment for complicated urinary tract infections (cUTI), including pyelonephritis, in pediatric patients.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."