Pharmaceutical Business review

Iterum Therapeutics raises $65m in new financing round

The financing was led by new investor Arix Bioscience plc, and included Pivotal bioVenture Partners, Advent Life Sciences, Domain Associates and Bay City Capital. All of Iterum’s current investors (Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners) also participated in the round.

Iterum is developing sulopenem, a novel oral and intravenous antibiotic, for the treatment of Gram-negative multi-drug resistant infections.

The proceeds of this financing will be used for production of clinical supplies and registration batches, expanding the chemistry, manufacturing and control and development organizations and execution of the uncomplicated urinary tract infections Phase 3 pivotal program.

The estimated timeline for filing an New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) is year-end 2019, with Phase 3 pivotal trials expected to begin in the first half of 2018.

Sulopenem has demonstrated broad-spectrum in vitro activity against extended spectrum β-lactamase producing and quinolone-resistant Gram-negative pathogens that are increasingly prevalent in both the inpatient and outpatient settings.

These resistant pathogens are common causative agents of the initial target indications for sulopenem, including uncomplicated urinary tract infections, complicated urinary tract infections and complicated intra-abdominal infections (uUTI, cUTI and cIAI).

Corey Fishman, CEO of Iterum, said: “The closing of this round, which was highly competitive and substantially oversubscribed, is an important milestone for Iterum.

“This success reflects the significant achievements we have made to date in the development of sulopenem. We are excited to welcome such high quality Series B investors into the existing blue-chip syndicate.

“With more than 25 million infections annually in the U.S. in our initial indications, and effective treatment options becoming more and more limited due to increasing resistance, we believe that sulopenem has the potential to play an important role in treating these infections.”

As part of the financing, Mark Chin of Arix Bioscience, Tracy Saxton of Pivotal bioVenture Partners and Shahzad Malik of Advent Life Sciences will join Iterum’s Board of Directors.

Chin, investment manager at Arix Bioscience, said: “Arix is delighted to lead Iterum’s financing of its novel, oral penem that has the potential to significantly improve the treatment paradigm for patients with multidrug resistant Gram-negative infections.

“Since Iterum was founded in late 2015, it has made tremendous progress in the development of sulopenem, and we are excited to provide capital to fund the Phase 3 development of this novel product.”