Iterum Therapeutics (NASDAQ: ITRM) announced positive results from its pivotal Phase 3 REASSURE trial, where oral sulopenem demonstrated superiority over Augmentin for the treatment of uncomplicated urinary tract infections (uUTI). The announcement led to H.C. Wainwright upgrading Iterum's stock from Neutral to Buy, setting a price target of $6.00.
Phase 3 Trial Results
The REASSURE trial evaluated sulopenem etzadroxil and probenecid combination therapy against Augmentin in patients with uUTIs. The study met its primary endpoint, demonstrating statistical superiority in overall response rate. Specifically, 61.7% of patients treated with sulopenem achieved clinical success and microbiologic eradication, compared to 55.0% of those treated with Augmentin.
The lower bound of the 95% confidence interval for the treatment difference was above the threshold for both non-inferiority and superiority. Sulopenem also met secondary endpoints, including clinical success and microbiologic eradication at the test-of-cure visit.
Regulatory Pathway
Iterum Therapeutics is preparing to resubmit a New Drug Application (NDA) to the FDA in the second quarter of 2024, with potential FDA approval anticipated by the fourth quarter of 2024. The trial design was previously agreed upon with the FDA under a special protocol assessment, increasing the likelihood of a positive regulatory outcome.
Market Potential
The successful trial results and anticipated FDA approval have positioned Iterum Therapeutics favorably in the antibiotic treatment market, particularly for urinary tract infections. H.C. Wainwright's upgrade reflects confidence in sulopenem's market potential.
Financial Considerations
While Iterum Therapeutics holds more cash than debt, the company is quickly burning through cash and has not been profitable in the last twelve months. Investors should consider these factors, along with the stock's high volatility, when evaluating Iterum's financial position and market outlook.
