Iterum antibiotic fails in Phase III for intra-abdominal infections, further driving down shares

Iterum became the latest anti-infective developer to suffer a blow in the market, losing more than a third of its value with a narrow miss on the primary endpoint in a pivotal trial. Still, the company doesn't believe the setback is enough to doom the antibiotic’s potential for a regulatory submission.

Sulopenem failed to show non-inferiority to another β-lactam antibiotic in the Phase III SURE trial to treat complicated intra-abdominal infections. The company said an analysis of the trial’s results showed the responses were “one patient shy of the target” for non-inferiority, however, and at least one prespecified analysis suggested a narrower difference in clinical response rates between the two antibiotics than the primary analysis showed...