A year ago, the ex-Durata execs at Iterum Therapeutics unveiled a $65 million B round and a Phase III game plan for the antibiotic they grabbed from Pfizer’s shelf. Now, they are seeking $92 million more in IPO cash to fund the late-stage studies that they hope will get them at the FDA’s doors.
Led by CEO Corey Fishman and CSO Michael Dunne, Iterum plans to dedicate most of the funds to Phase III trials of both oral and IV versions of sulopenem, a penem β-lactam antibiotic. They will focus on three indications: uncomplicated urinary tract infections (uUTI), complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). If all three gets initiated later this year as planned, some of the money will also go to Pfizer in the form of milestone payments.
By the second half of 2019, Iterum aims to complete enrollment and produce top-line data for all three trials, with plans to submit NDAs immediately after. And they have just recently hired a chief commercial officer, Jeff Schaffnit, to lead the action.
As the threat of drug resistance continues to grow, the feds have tried adding incentives to help encourage more antibiotic development work. While Big Pharma has largely stayed out of the field, there’s plenty of biotech activity. Achaogen, Spero and Melinta are among Iterum’s rivals racing to get a UTI pill to the market.
Still, Iterum’s program attracted the backing of some marquee venture players, including Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and Arix Bioscience.
The biotech has its global headquarters in Dublin, Ireland, with a US office in Chicago and R&D operations in Connecticut. It plans to list on Nasdaq under the symbol $ITRM
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