By Chris Wack
Iterum Therapeutics PLC said the U.S. Food and Drug Administration decided it can't approve the company's new drug application for sulopenem etzadroxil/probenecid oral sulopenem in its present form.
The FDA acknowledged in a letter Friday that the Phase 3 clinical trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population, Iterum said.
However, the FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone, the company said.
The FDA recommended that Iterum conduct at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug, the company said.
Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation doesn't raise an approvability issue, the company said.
The FDA didn't identify any chemistry, manufacturing or controls issues, nor were there any safety issues found in over 1,800 patients treated with sulopenem across the clinical development program, the company said.
Iterum intends to review the FDA's decision with its advisers and plans to request a Type A meeting in the coming weeks. Following the meeting, anticipated to be late in the third quarter, Iterum expects to provide an update on next steps as to the potential additional clinical and non-clinical work to be done prior to a resubmission of the NDA for approval of oral sulopenem.
Iterum said it had cash, cash equivalents and short-term investments of $100.5 million at the end of the first quarter of 2021. Based on the current operating plan and subject to final determination of the design and planned conduct of additional clinical and potential nonclinical development for sulopenem, the company believes that it is well positioned financially to fund its operations into the second half of 2023.
The company had said in May that it was aiming to launch oral sulopenem in the fourth quarter of 2021, if approved.
Iterum shares were down 39% to 69 cents.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires