Spero’s UTI candidate gets the CRL hammer as the company falls into penny stock status
Spero Therapeutics has been struggling in the past few years, dealing with FDA holds and staff reductions amidst a rough biotech market, and the latest news from the Massachusetts-based company confirms what it anticipated in May: a CRL.
The company was slapped with the no-go for its NDA, the biotech disclosed Monday. The company was seeking approval for tebipenem HBr oral tablets, intended for the treatment of adult patients with complicated urinary tract infection, or cUTI, including pyelonephritis. The FDA had set a PDUFA date of June 27.
According to Spero, the FDA had completed its review of the NDA and determined the application could not be approved in its present form, an action that Spero expected. In May, the CRL was anticipated by the company based on feedback received at the late-cycle meeting, in which the agency outlined potential deficiencies in the application. In the CRL, the FDA ultimately concluded that Spero’s Phase III study of tebipenem HBr was insufficient to support approval and that additional clinical study would be required.
As a result, Spero underwent “immediate cessation” of commercialization work on the drug. The biotech also let its CMO and COO go in a sweeping layoff that saw Spero cut 75% of its workforce, which comprised 146 people at the end of 2021.
“We are disappointed with the FDA’s decision, but we look forward to our continued dialogue, addressing the agency’s concerns and outlining a clear path forward for tebipenem HBr,” said Ankit Mahadevia, Spero’s CEO.
This drug is important for Spero: In 2021, it entered into a revenue interest financing agreement with investment firm HealthCare Royalty Partners for up to $125 million for the candidate. As part of the agreement, Spero received $50 million from HealthCare Royalty Partners, and if granted FDA approval, Spero would receive an additional $50 million, plus an additional $25 million upon an undisclosed commercial milestone.
But this is not the first time the company has had to halt its work due to FDA intervention. In 2021, a clinical hold was placed on its Phase IIa trial for an oral therapy candidate for the treatment of a rare, orphan pulmonary disease caused by non-tuberculous mycobacterial infections.
That hold came after it notified regulators of its decision to pause dosing in the study after scientists had uncovered “mortalities with inconclusive causality” in a toxicology study involving non-human primates, and the Safety Review Board recommended that they hit the brakes. The hold was eventually lifted in January.
All this activity has dropped the company’s stock $SPRO immensely. The company entered penny stock status earlier this month, with its price dropping 93% since last December.