A tough call from the FDA has led Spero Therapeutics to become the latest in an ever-growing line of biotechs taking evasive action to stay afloat. The company will halt the commercialization of its late-stage urinary tract infection drug and lay off three-quarters of its staff.
Although a review of the drug, called tebipenem HBr, is ongoing, a discussion with the regulator in late April suggested that the data submitted would be insufficient for approval, Spero said in a May 3 announcement.
As a result, the Cambridge, Massachusetts-based biotech will immediately defer current commercialization activities and pivot to its antibiotic resistance solutions SPR720 and SPR206. A clinical hold of SPR720 in a phase 2 trial for non-tuberculous mycobacterial lung disease was lifted in January, while SPR206 is undergoing trials to treat MDR gram-negative bacterial infections.
The biotech will also lay off 75% of its staff from a full-strength total of 146 to just 35 full-time employees, according to an SEC filing. Chief Operating Officer Cristina Larkin and Chief Medical Officer David Melnick, M.D., will both leave the company in July.
The resulting cost-savings should keep the company afloat through to late 2023, Spero said. The company ended 2021 with an estimated $146.4 million in cash.
“While this decision was difficult, we believe it is in the best interest of the company and its shareholders,” Ankit Mahadevia, M.D., CEO of Spero Therapeutics, said in a statement. “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.”
The company also pledged to continue to engage with the FDA on the appropriate path forward for tebipenem HBr.