The FDA denied it in July, but now Iterum Therapeutics has another shot at gaining approval for its antibiotic after meeting with the regulator last week.
The Dublin-based biotech is designing another phase 3 trial for the oral treatment in patients with uncomplicated urinary tract infections, Iterum said Tuesday night. More clarity on the trial design could come as early as third-quarter earnings, RBC Capital Markets analysts estimated in a note to clients.
The news is music to investors’ ears. Iterum’s shares were up about 15% to $0.63 a piece as of 9:42 a.m. E.T. That’s still far off the company’s six-month peak of $2.39 on June 29.
Iterum’s Type A meeting with the FDA is “encouraging,” the analysts said, noting they spoke with management. One additional trial will be enough to pass muster for another chance at clearing the FDA finish line, the analysts said.
“We had a successful meeting with the FDA and have established various potential paths forward to address the request in the CRL for additional data in support of our NDA,” said Corey Fishman, Iterum CEO, in a statement.
The FDA denied the oral antibiotic, dubbed sulopenem, after a speedy review because it wanted more data to support approval. The agency said the phase 3 study showed the drug beat another antibiotic, ciprofloxacin, at treating infections in patients whose infections resisted that other antibiotic. It wasn’t enough data to clear the hurdle, though.
Now, Iterum will work with external vendors to design the trial around different parameters, including comparator or placebo-controlled, which subpopulations to include and endpoints to base the study on, RBC analysts wrote in their note. The biotech, which has U.S. operations in Chicago, expects to continue talking with the FDA throughout the design process.
The meeting is a step in the “right progress toward a development reset” following the July no-go, the analysts wrote. Iterum maintained $91.5 million in the coffers at the end of the second quarter, the company said. With another trial and potential nonclinical development needed for the antibiotic, Iterum said it can finance itself into the second half of 2023.