Iterum’s Antibiotic for Super Bugs Falls Short in Phase 3, Shares Sink
Summary
Iterum (NASDAQ: ITRM) reported preliminary Phase 3 data late Tuesday for its antibiotic, sulopenem, which is being tested as a treatment for complicated intra-abdominal infections. The clinical trial compared the Iterum drug to ertapenem, an antibiotic that’s used to treat intra-abdominal infections but comes with the risk of central nervous system side effects, including hallucinations and seizures. In a prepared statement, Iterum CEO Corey Fishman characterized the result as “narrowly missing the primary endpoint.” He added that the data show potential for the drug to address growing antibiotic resistance. In a research note, SVB Leerink analyst Ami Fadia wrote that the totality of the Iterum’s data suggest that sulopenem has the potential to be an active drug, and the urinary tract infection study could be successful. But she added the chance of approval in intra-abdominal infections is low, as her firm knows of no antibiotics that received an FDA nod after missing the primary endpoint of a pivotal study.
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