Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
- Positive topline results from the REASSURE Phase 3 clinical trial
- Oral sulopenem demonstrated non-inferiority to Augmentin® with statistical superiority
- Plans to resubmit NDA for oral sulopenem in Q2 2024
- Focus on strategic process to maximize value for stakeholders
- None.
Insights
The REASSURE Phase 3 clinical trial results are a significant milestone in the development of new antibiotics, particularly in the context of rising antimicrobial resistance. The trial's primary endpoint was met, demonstrating that oral sulopenem is non-inferior to Augmentin®, which is noteworthy given the latter's widespread use as a standard treatment for urinary tract infections (UTIs). The statistical superiority shown by oral sulopenem in overall response rates suggests a potential improvement over existing treatments. This could lead to a shift in prescribing practices if sulopenem is approved, affecting market dynamics for UTI treatments.
From a research perspective, the treatment's efficacy and safety profile are encouraging, with a low incidence of adverse events comparable to Augmentin®. This is particularly relevant given the safety concerns that often accompany new drug approvals. The absence of new safety signals is a positive indicator for regulatory approval and future market acceptance. Additionally, the potential application of sulopenem in other indications, such as complicated UTIs, could further expand its market impact.
Iterum Therapeutics' announcement of positive trial results and the planned resubmission of its New Drug Application (NDA) for oral sulopenem has substantial implications for its financial prospects. The company's strategic decision to sell, license, or otherwise dispose of its rights to sulopenem aims to maximize value for stakeholders, indicating a potential influx of capital or revenue-sharing arrangements that could enhance Iterum's financial stability and growth potential.
For investors, the trial's success and Iterum's subsequent actions suggest a potential increase in the company's stock value. The anticipation of FDA approval, based on addressing deficiencies from the previous Complete Response Letter (CRL), could lead to significant market valuation changes in the short-term. Furthermore, the long-term impact on Iterum's revenue streams from sulopenem, especially if it becomes the first oral penem antibiotic approved in the U.S., could be substantial given the large market for UTI treatments.
The development of new antibiotics like oral sulopenem is an important economic event in the pharmaceutical industry due to the high costs associated with antimicrobial resistance. The potential approval and commercialization of sulopenem could influence the overall healthcare expenditure on UTIs, which is significant given the high prevalence of the condition. If sulopenem proves to be more effective than current treatments, it could lead to reduced healthcare costs through decreased rates of hospitalization and complications associated with resistant infections.
Moreover, the success of sulopenem could spur further investment in antibiotic research, a field that has been historically underfunded relative to its importance in public health. The economic ripple effects of such a development could include job creation in the biotech sector, increased R&D spending and a potential boost to related industries, such as diagnostic equipment and pharmaceutical manufacturing.
Phase 3 REASSURE Trial Met Primary Endpoint of Non-Inferiority to Augmentin®; Demonstrated Statistical Superiority
Re-submission of NDA to FDA Expected in Q2 2024
Potential to be First Oral Penem Approved in the
Management to host a conference call at 8:30 a.m. ET today
"We are very pleased to announce positive data from this confirmatory trial, which was conducted under special protocol assessment (SPA) agreement with the
Results demonstrate that oral sulopenem was non-inferior to Augmentin® with respect to the trial's primary endpoint, overall response (combined clinical cure plus microbiologic eradication) at the test-of-cure (TOC) visit in the microbiological-modified-intent-to-treat susceptible (m-MITTS) population. Oral sulopenem showed overall success in
The table below summarizes the key efficacy data from the REASSURE trial at the TOC visit:
Sulopenem/probenecid | Augmentin® | Treatment Differencei | |
Overall Responseii | 296 (61.7) | 243 (55.0) | 6.7 (0.3, 13.0) |
Clinical Successiii | 371 (77.3) | 339 (76.7) | 0.6 (-4.8, 6.1) |
Microbiological Successiv | 361 (75.2) | 295 (66.7) | 8.5 (2.6, 14.3) |
[i] | Difference in oral sulopenem versus Augmentin® in the m-MITTS population |
[ii] | Combined clinical and microbiological success (primary endpoint) |
[iii] | Clinical success at TOC = symptom resolution + no new uUTI symptoms |
[iv] | Eradication of qualifying uropathogen to <103 CFU/mL at TOC visit |
Both oral sulopenem and Augmentin® were well tolerated in this study with discontinuations due to adverse events occurring in <
Iterum expects to present complete results from the REASSURE trial at an upcoming scientific meeting.
"In addition to achieving non-inferiority for the primary endpoint of overall response at the TOC visit in the Augmentin®-susceptible population in the REASSURE trial, the lower limit of the
Iterum expects to resubmit its NDA for oral sulopenem to the FDA in the second quarter of 2024. Provided that the resubmitted NDA addresses all of the deficiencies identified in the Complete Response Letter (CRL) Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the fourth quarter of 2024).
Conference Call and Webcast Details
Iterum will host a conference call and webcast today, Tuesday, January 30, 2024, at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows:
Access code: 781689
The conference call will also be webcast live. The webcast can be accessed here.
About REASSURE
The REASSURE trial is designed as a non-inferiority (
About Urinary Tract Infections (UTIs)
UTIs are among the most common bacterial infections encountered in the community. There are approximately 15 million emergency room and office visits for symptoms of UTIs and over 30 million uUTIs treated in
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is currently advancing its first compound – sulopenem – a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications. For more information, please visit www.iterumtx.com.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the development, therapeutic and market potential of sulopenem, our ability to address the deficiencies set out in the complete response letter received in July 2021, the expected timing of resubmission of the NDA, the expected timing of review by the FDA and Iterum's strategic process to sell, license, or otherwise dispose of its rights to sulopenem. In some cases, forward-looking statements can be identified by words such as "may," "believes," "intends," "seeks," "anticipates," "plans," "estimates," "expects," "should," "assumes," "continues," "could," "would," "will," "future," "potential" or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Iterum's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside Iterum's control, including uncertainties inherent in the conduct of clinical and non-clinical development, changes in regulatory requirements or decisions of regulatory authorities, the timing or likelihood of regulatory filings and approvals, including the potential resubmission of the NDA for oral sulopenem, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of Iterum's expectations regarding how far into the future Iterum's cash on hand will fund Iterum's ongoing operations, Iterum's ability to maintain its listing on the Nasdaq Capital Market, risks and uncertainties concerning the outcome, impact, effects and results of Iterum's pursuit of strategic alternatives, including the terms, timing, structure, value, benefits and costs of any strategic process and Iterum's ability to complete one at all and other factors discussed under the caption "Risk Factors" in its Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023, and other documents filed with the SEC from time to time. Forward-looking statements represent Iterum's beliefs and assumptions only as of the date of this press release. Except as required by law, Iterum assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
View original content:SOURCE Iterum Therapeutics plc
FAQ
What are the results of the REASSURE trial?
When will Iterum resubmit the NDA for oral sulopenem?
What is Iterum's plan regarding sulopenem?
What is the ticker symbol for Iterum Therapeutics plc?
