Iterum Therapeutics' Orlynvah (sulopenem) has received FDA approval for the treatment of uncomplicated urinary tract infections (uUTIs), marking a significant advancement in addressing antibiotic resistance and providing a new option for physicians. The approval was supported by positive results from the SURE1 and REASSURE trials, which compared Orlynvah to ciprofloxacin and augmentin, respectively.
SURE1 Trial Findings
The SURE1 trial demonstrated that Orlynvah was superior to ciprofloxacin in patients with infections caused by ciprofloxacin-resistant organisms. However, in an unexpected outcome, Orlynvah did not show non-inferiority against ciprofloxacin in patients with susceptible organisms. According to Steven Aronin, MD, SVP of Clinical Development at Iterum, this anomaly may be attributed to the differential impact of antibiotics on the bacterial flora. "Cipro sticks around a long time," Aronin explained, suggesting that the prolonged presence of ciprofloxacin led to better outcomes in the 12-day follow-up in some cases.
Corey Fishman, CEO of Iterum Therapeutics, emphasized the safety concerns associated with ciprofloxacin, noting that it is no longer recommended as a first-line agent due to significant resistance issues and severe potential side effects. "For uncomplicated infections, both the FDA and EMA have stated that it no longer makes sense to use Cipro as a first-line treatment for uncomplicated infections like uUTIs," Fishman stated.
REASSURE Trial Results
To address the unexpected findings from the SURE1 trial, the REASSURE trial compared Orlynvah to augmentin. This trial confirmed Orlynvah's superiority in susceptible populations and established non-inferiority across the overall population. This is particularly important for empiric therapy in community settings where options are limited.
Aronin highlighted the importance of the overall population data for treating physicians: "Patients who show up with symptoms of a UTI and have an abnormal urinalysis—they have a UTI, but you don't know the bugs yet... It's important for the treating doctor to understand that we're just as good as the other agents in this space."
Market Strategy and Future Plans
Iterum Therapeutics is now focusing on securing a strategic partner to launch Orlynvah effectively. Fishman noted that this model differs from historical antibiotics, with primary care doctors being the main prescribers in the community setting. The company aims to collaborate with companies that already have products prescribed by primary care physicians, urologists, and OB-GYNs.
"We’d love to do that sooner rather than later because we want to get this product on the market, treating patients and helping physicians with limited options," Fishman concluded. The company is optimistic about finding a partner to introduce Orlynvah to the market, addressing the unmet need for effective UTI treatments.
According to Aronin, physicians are enthusiastic about the prospect of having Orlynvah available to treat their patients, recognizing the critical gap in UTI treatment options and the importance of antibiotic stewardship.
