Iterum announces topline results from SURE1 trial for uUTI patients
Date: 2020-07-01   Author: Saipriya Iyer  Category: #news

Iterum announces topline results from SURE1 trial for uUTI patients

Iterum Therapeutics plc, a pharmaceutical company, has recently announced the topline results from the SURE1 (Sulopenem for Resistant Enterobacteriaceae) clinical trial. This clinical trial has been conducted for the treatment of uUTI (Uncomplicated Urinary Tract Infections).

Sulopenem is a novel compound that could be the 1st penem antibiotic indicated to treat uUTI. There are 2 independent primary endpoints of the SURE1 trial. The favorable achievement of an endpoint can lead to the marketing approval based on the discussions with the U.S. FDA. Sulopenem reached the primary endpoint in a patient population with quinolones-resistant baseline pathogens, as it demonstrates its superiority as compared to ciprofloxacin for the effective treatment of the uUTI patients.

The results of the trial were highly significant, with a <0.001 p-value. However, sulopenem did not obtain the primary endpoint and was inferior to ciprofloxacin among the 2nd patient population with quinolone-susceptible pathogens. Outcome differences were driven by the asymptomatic bacteriuria post-treatment rate. Sulopenem was well tolerated in SURE1 with a safety profile consistent with the SURE3 and SURE2 trials.

1,670 patients were enrolled in the randomized, double-blind, multi-center clinical trial. The candidates are administered oral sulopenem twice a day for 5 days or the same dose of oral ciprofloxacin for 3 days of treatment. The outcome analysis in both non-susceptible and susceptible patients was conducted to describe the overall results.

Treatment-related adverse impacts were observed among 1,660 patients in the safety population, with 11.9% and 11.4% of patients on ciprofloxacin and sulopenem respectively.

Rate of adverse events were 7.3% and 7.6% diarrhea, 3.4% and 4.0% nausea, and 2.2% and 2.2% headache for patients treated with sulopenem and ciprofloxacin, respectively. Adverse impact discontinuations were seen in 1.1% and 1.5% of patients offered with sulopenem and ciprofloxacin respectively. Additionally, SAE (serious adverse events) were seen in 0.6% of patients that obtained sulopenem and 0.4% of patients that received ciprofloxacin. Based on this data, the company is planning to request a meeting with the U.S. FDA for filing strategy discussion.

Source credit:

https://pipelinereview.com/index.php/2020062975163/Small-Molecules/Iterum-Therapeutics-Announces-Topline-Results-from-its-Phase-3-Clinical-Trial-of-Oral-Sulopenem-for-the-Treatment-of-Uncomplicated-Urinary-Tract-Infections.html



About Author


Saipriya Iyer

Saipriya Iyer

Saipriya Iyer currently works as a content developer for AlgosOnline. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her belt, she has dabbled with website...

Read More

More from Saipriya


Post Recommendents

Coconut Milk Market Report, Growth Forecast, Industry statistics till 2026
Author: Rahul Varpe

DEC Research declares the publication of its latest research report, with the title ‘Global Coconut Milk Market’. This report sheds light on the analysis of the industry challenges, growth opportunities, industry ...


Breakfast Cereals Market Set for Rapid Growth and Trend, by 2026
Author: Rahul Varpe

DEC Research has published its most recent report with the title ‘Global Breakfast Cereals Market In-depth Research on Industry Size, Trends, and Emerging Growth Factors to 2026’. The report basically contains an ...


Beverage Processing Equipment Market with Segmentation, Statistical Forecast and Competitive Analysis – 2026
Author: Rahul Varpe

DEC Research has recently added a detailed research report on the Beverage Processing Equipment Market by means of Industry Strategies, Evolving Technology, Growth rate, Business Competitors, Key Companies and Forecast to 202...