Iterum Therapeutics plc (NASDAQ: ITRM) is engaged as a clinical-stage pharmaceutical company, which is focused on the research and development of advanced anti-infectives to help counteract growing issue of multi-drug resistant pathogens. Shares of the pharmaceutical company are surging 68% through afternoon trading on Monday, July 11, 2022. Over the past three months, Iterum Therapeutics has seen average daily volume of 1.17 million shares. However, volume of 131.65 million shares or dollar volume of around $55.29 million, has already exchanged hands through afternoon trading.
Shares of Iterum Therapeutics are soaring after the company announced that it has reached a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Under the agreement, Iterum and the FDA laid out guidelines, such as design, endpoints and statistical analysis for the company’s upcoming Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid for the treatment of uncomplicated urinary tract infections.
The planned Phase 3 pivotal study is designed as a non-inferiority trial, which compares oral sulpenem and Augmentin and is entitled “A prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem etzadroxil/probenecid versus oral amoxicillin/clavulanate for treatment of uncomplicated urinary tract infections (uUTI) in adult women.”
During the Phase 3 trial, patients will be randomly provided with either oral sulopenem twice daily for five days or Augmentin twice daily for five days. The primary endpoint of the trial is the overall response at Day 12 of the study. The Phase 3 clinical trial is estimated to enroll as many as 1,966 patients with an anticipated beginning enrollment launch sometime during the fourth quarter of 2022.
“We are pleased to have concluded discussions with the FDA and reached agreement on key elements of the trial design to support the potential resubmission of the NDA for oral sulopenem for uUTI under the SPA process,” said Corey Fishman, Chief Executive Officer. “The SPA underscores our alignment with the FDA on important regulatory, clinical and scientific requirements for our planned Phase 3 trial in uUTI and reflects our ongoing commitment to bring this valuable therapy to market. We are excited about this important milestone and are looking forward to starting recruitment for this trial as soon as possible.”
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