The clock is ticking for Iterum after FDA hands down CRL for Pfizer castoff antibiotic
Iterum knew its odds were slim as it awaited an FDA ruling on a key urinary tract infection drug with its bank account running low. The FDA, however, wasn’t impressed, and Iterum’s days look numbered.
The FDA has sent the tiny biotech a complete response letter for the antibiotic sulopenem, shutting down hopes at getting the oral medication across the finish line, the drugmaker revealed Monday.
In Iterum’s telling of the details — the letter was not made public — the FDA pushed back on the drug’s application in women with uncomplicated UTIs caused by “designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone” due to a lack of clinical data.
However, the agency did acknowledge the drug showed clinical efficacy in terms of overall response rate compared with common antibiotic ciprofloxacin in patients resistant to that drug, Iterum said. The biotech also said there were no manufacturing or safety issues cited in the letter.
The agency recommended at least one “adequate and well-controlled” clinical trial for those patients, possibly using a different comparator drug, Iterum said. The drugmaker said it would discuss the best path forward for the FDA as it takes stock of the situation.
That effectively represents going back to the drawing board, and investors are picking that up. Shares of $ITRM were trading down around 40% before the opening bell Monday.
The setback officially puts a shot clock on Iterum’s efforts as the drugmaker said it has around $100 million in the bank, enough scratch to take operations through mid-2023, by its lights. It’s a slightly better position than Iterum faced late last year, when it had just $8.7 million in the bank and a small window to keep the lights on.
The UTI indication here was actually one of a few Iterum has looked at for sulopenem, a Pfizer castoff drug, with positive Phase III results potentially cracking open a market with as many as 6 million US patients. Meanwhile, other shots on goal haven’t been as successful. A regimen of the intravenous formulation followed by tablets couldn’t match other established antibiotics in complicated intra-abdominal infections or complicated urinary tract infection.
Meanwhile, Iterum’s setback is pretty par for the course in an antibiotic R&D space that has seen little innovation in recent years with Big Pharma running for the hills and fewer and fewer biotech teams willing to spend the time and money looking for a breakthrough.
Can Iterum beat the clock for 2023? We’ll have to wait and see.