Iterum Therapeutics, the developer of an antibiotic designed to treat Gram-negative multidrug-resistant infections, said today it has closed a $65 million Series B financing.
Arix Bioscience led the financing, joined by four other previous investors in Iterum’s $40 million series A round, closed in November 2015—Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures, and New Leaf Venture Partners. Four new investors were Advent Life Sciences, Domain Associates, Bay City Capital, and Pivotal bioVenture Partners.
Iterum is developing its first product candidate sulopenem, a novel oral and intravenous antibiotic called a penem that the company licensed from Pfizer in late 2015.
Under that agreement—whose value has not been disclosed—Iterum paid Pfizer an initial equity interest and up-front cash. Pfizer is also eligible to receive additional equity and payments tied to achieving development and commercial milestones, as well as royalties based upon global net sales of any potential sulopenem products.
Pfizer first sought to develop sulopenem as an antibiotic during the 1980s. In 2010, a Phase II study showed 90% and 88% cure rates for two regimens of sulopenem, compared with 63% for patients enrolled in ceftriaxone with a switch to amoxicillin/clavulanate—but the results were deemed not statistically significant as only 23 patients completed the trial.
According to Iterum, sulopenem has demonstrated broad-spectrum coverage, including Gram-negative pathogens, and has shown potent in vitro activity against Enterobacteriaceae (ESBL) mutants of Escherichia coli and Klebsiella pneumoniae.
These pathogens, Iterum said, are commonly associated with its initial indications of interest: uncomplicated urinary tract infections (uUTI), complicated urinary tract infections (cUTI), and complicated intra-abdominal infections (cIAI).
Iterum said it will use proceeds from the financing to complete a Phase III pivotal trial assessing sulopenem in uUTI, as well as advance the antibiotic’s broader Phase III pivotal program. Trials are expected to begin in the first half of 2018, with Iterum planning to file an NDA with the FDA by the end of 2019.
As part of the financing, three new investor members will join Iterum’s Board of directors—Mark Chin of Arix Bioscience, Tracy Saxton of Pivotal bioVenture Partners, and Shahzad Malik of Advent Life Sciences.
“Iterum has made great progress since its launch and we are very excited about its potential,” Arix Bioscience CEO Joe Anderson, Ph.D., said in a separate statement issued by his firm. “We are privileged to join the company at this stage in its development and to help support the achievement of its goals.”
Iterum’s executive team is headed by CEO Corey Fishman and CSO Michael Dunne, M.D. Both were key executives at Durata Therapuetics, which developed the new antibiotic Dalvance® (dalbavancin) that was acquired in 2014 by Actavis (now Allergan) for $675 million-plus.