Iterum says FDA is in 'general alignment' on proposed new PhIII for rejected uUTI drug
Iterum Therapeutics is painting a rosier picture of its once-rejected antibiotic after meeting with the FDA last week.
The agency was in “general alignment” with the Dublin and Chicago-based biotech after discussing a proposed additional Phase III clinical study of sulopenem for uncomplicated urinary tract infections, or uUTI, Iterum said Wednesday.
Next up is an agreement request with the regulator for a special protocol assessment of the clinical trial, which will be a non-inferiority study comparing Iterum’s oral drug to amoxicillin clavulanate, an antibiotic once involved in a legal dispute between GlaxoSmithKline and Novartis over generics production, in adult women.
Iterum expects to request the agreement in the “coming weeks.” Upon finalization, the biotech aims to kick off patient enrollment in the second half of this year.
The biotech, founded in 2015 and which debuted on Nasdaq in May 2018, suffered a blow to its R&D efforts last July when the FDA handed down a rejection of the drug. The complete response letter added to the deluge of difficulties dragging down the antibiotics field. A lack of clinical data was the agency’s core reasoning, Iterum said at the time.
Iterum was born out of an acquisition of the former Pfizer antibiotic. With about $100 million in the coffers around the time of the CRL, Iterum faced a daunting mid-2023 runway.
As of the latest publicly disclosed tally, Iterum had $81.3 million in cash, cash equivalents and short-term investments. That’s enough to keep the lights on into 2024, the biotech said in late March. On March 9, the company received a 180-day extension of its Nasdaq listing deficiency, giving Iterum until Sept. 5 to meet the minimum bid price requirement.
Iterum’s shares $ITRM were down about 6%, at less than one quarter apiece, before Wednesday’s opening bell.
Executives said on a March investor call that the company had sufficient cash to fund Iterum into 2024 and a “pretty good chance to finish that study out,” referring to the potential new Phase III. CEO Corey Fishman declined to project cost and timing of the study when asked by an analyst, citing ongoing discussions with the FDA and a yet-to-be-finalized trial design.