Iterum Therapeutics (ITRM) Maxim Group’s 2024 Healthcare Virtual Summit summary

Clinical development and regulatory update

• Sulopenem is positioned to become the first oral penem for uncomplicated urinary tract infections, with a PDUFA date set for October 25, just 10 days away.

• Two phase III trials demonstrated non-inferiority and, in some cases, statistical superiority to comparators, supporting efficacy and safety.

• The FDA advisory committee acknowledged two adequate and well-controlled studies, increasing confidence in potential approval.

• The company is targeting elevated-risk patients, such as women over 65, diabetics, and those with recurrent infections, representing about 27 million prescriptions annually.

• The company is prepared for a label focused on uncomplicated UTI and is aligned with regulators on appropriate patient selection.

Market landscape and unmet need

• Over 40 million prescriptions are written annually for uncomplicated UTIs, with most current oral antibiotics being old and facing high resistance rates.

• There has been no new oral antibiotic approved for this indication in over 20 years, highlighting a significant unmet need.

• Elevated-risk patients are a key focus due to higher risk of complications from ineffective treatment.

• The company estimates about two-thirds of the UTI market consists of elevated-risk patients.

• Education and stewardship are emphasized to ensure appropriate use and minimize resistance development.

Industry challenges and policy environment

• Antimicrobial resistance is a growing crisis, with projections of up to 40 million deaths by 2050 from superbugs.

• Large pharmaceutical companies have largely exited antibiotic development, leaving smaller firms to fill the gap despite significant financial challenges.

• The GAIN Act provides incentives like extended exclusivity and expedited review, but further economic incentives are needed.

• The PASTEUR Act, if passed, could provide additional support for late-stage antibiotic developers.

• Government and industry collaboration is seen as essential to sustain antibiotic innovation.