subslover
3 months ago
Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
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 U.S.
Management to host a conference call at 8:30 a.m. ET today
DUBLIN and CHICAGO, Jan. 30, 2024 /PRNewswire/ -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next-generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced positive topline results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs).
"We are very pleased to announce positive data from this confirmatory trial, which was conducted under special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA)," said Corey Fishman, Iterum's Chief Executive Officer. "With the positive data from this trial, we plan to resubmit our New Drug Application (NDA) for oral sulopenem for the treatment of uUTI in the second quarter of 2024. At the same time, with these results in hand, we will be focusing on a strategic process to sell, license, or otherwise dispose of our rights to sulopenem with the goal of maximizing value for our stakeholders. We believe there is tremendous value in sulopenem as a potential new, oral antibiotic for the uUTI indication which has over 30 million infections annually in the U.S., rising resistance to all currently prescribed oral antibiotics, and a complete lack of new product innovation over the last 20 years."
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 61.7% of patients compared to 55.0% for Augmentin®, demonstrating statistically significant superiority of oral sulopenem versus Augmentin®.
The table below summarizes the key efficacy data from the REASSURE trial at the TOC visit:
Sulopenem/probenecid500 mg/500 mgBIDN=480n (%)
Augmentin® (Amoxicillin/clavulanate)875 mg/125 mgBIDN=442n (%)
Treatment Differencei (95% CI)
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)
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
swanlinbar
5 months ago
$ITRM >Iterum Therapeutics Regains Compliance with Nasdaq Bid Price Rule
December 04 2023 - 08:00AM
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Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that it has received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Bid Price Rule") for continued listing on The Nasdaq Capital Market.
The Company was previously notified on September 26, 2023, that it was not in compliance with the Bid Price Rule because its ordinary shares failed to meet the closing bid price of $1.00 or more for 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided with 180 calendar days, or until March 25, 2024, to regain compliance. To regain compliance with the Bid Price Rule, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. This requirement was met on November 30, 2023, the tenth consecutive trading day when the closing bid price of the Company's ordinary shares was over $1.00.
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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and 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 Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Investor Contact:
Judy Matthews
Chief Financial Officer
312-778-6073
IR@iterumtx.com
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swanlinbar
10 months ago
$ITRM > Iterum Therapeutics to Present Data at ASM Microbe 2023
June 12 2023 - 06:23PM
GlobeNewswire Inc.
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Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that three posters will be presented at ASM Microbe 2023 conference.
The hybrid conference will be held from June 15-19 at the George R. Brown Convention Center in Houston, TX.
Data to be presented include:
Presentation title: ß-Lactamase Characterization of Baseline Enterobacterales Pathogens from a Phase 3 Trial of Sulopenem for the Treatment of Uncomplicated Urinary Tract Infection
Presentation type/category: P002-AAR01 Surveillance of antimicrobial resistance in clinical isolates; ß-lactamases (AAR-Friday-410)
Presenter: Steven I. Aronin, MD
Time/location: June 16, 2023, 10:00 a.m. – 5:00 p.m. CDT; Exhibit and Poster Hall B, C, D
Presentation title: ß-Lactamase Characterization of Baseline Enterobacterales Pathogens from a Phase 3 Trial of Sulopenem for the Treatment of Complicated Urinary Tract Infection
Presentation type/category: P002-AAR01 Surveillance of antimicrobial resistance in clinical isolates; ß-lactamases (AAR-Friday-417)
Presenter: Sailaja Puttagunta, MD
Time/location: June 16, 2023, 10:00 a.m. – 5:00 p.m. CDT; Exhibit and Poster Hall B, C, D
Presentation title: ß-Lactamase Characterization of Baseline Enterobacterales Pathogens from a Phase 3 Trial of Sulopenem for the Treatment of Complicated Intraabdominal Infection
Presentation type/category: P002-AAR01 Surveillance of antimicrobial resistance in clinical isolates; ß-lactamases (AAR-Friday-401)
Presenter: Sailaja Puttagunta, MD
Time/location: June 16, 2023, 10:00 a.m. – 5:00 p.m. CDT; Exhibit and Poster Hall B, C, D
These Posters will be made available on the Company’s website on the “Publications: Posters & Presentations” page under the “Our Science” tab once the conference ends.
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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and 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 Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
Investor Contact:
Judy Matthews
Chief Financial Officer
312-778-6073
IR@iterumtx.com
swanlinbar
10 months ago
ITRM > Dear Iterum Therapeutics plc Shareholder,
You are cordially invited to our Extraordinary General Meeting of Shareholders (“EGM”) to be held at 3 Dublin Landings, North Wall Quay, Dublin 1, Ireland on August 1, 2023 at 3.00 p.m., Irish time (10.00 a.m., Eastern Time).
The purpose of the EGM is to ask shareholders to grant the board of directors an updated power under Irish law to issue shares for cash without first having to offer those shares to existing shareholders under pre-emptive rights that would otherwise apply to the issuance. This pre-emption opt-out proposal is required as a matter of Irish law and is not otherwise applicable to the non-Irish, Nasdaq listed companies with which we compete. Receipt of this authority would merely place us on par with other Nasdaq-listed companies and provide us with the flexibility to undertake the capital raising that we believe may be necessary from time to time to allow us to continue to execute on our business plans and strategy.
The enclosed Notice of EGM and the accompanying proxy statement set forth more detail on the proposal that will be presented at the meeting. Our board of directors unanimously recommends a vote “FOR” Proposal No. 1 as set forth in the proxy statement.
We hope that you will participate in the meeting by voting through acceptable means as described in this proxy statement as promptly as possible. Your vote is important – so please exercise your right.
Sincerely,
____________________________
Corey N. Fishman
President and Chief Executive Officer
swanlinbar
1 year ago
$ITRM >Iterum Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results
March 16 2023 - 07:00AM
GlobeNewswire Inc.
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Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the fourth quarter and year ended December 31, 2022.
“We made significant progress in 2022 to move the clinical development of oral sulopenem forward leading to a potential resubmission of our new drug application (“NDA”) next year,” said Corey Fishman, Iterum’s Chief Executive Officer. “Enrollment in our REASSURE trial, which is being conducted under a Special Protocol Assessment (“SPA”) agreement with the U.S. Food and Drug Administration (“FDA”), is expected to be completed in the first half of 2024.”
Highlights and Recent Events
Enrollment in REASSURE Clinical Trial Ongoing: Iterum began enrollment in its pivotal Phase 3 clinical trial, REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales), for the treatment of uncomplicated urinary tract infections (“uUTI”) in adult women in October 2022. Enrollment is ongoing and expected to be completed in the first half of 2024. An interim analysis at 50% patient enrollment is expected to occur in the second half of 2023. This trial is being conducted under a SPA agreement with the FDA. The SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA, adequately addresses the objectives necessary to support the potential resubmission of Iterum’s NDA for oral sulopenem.
Two New U.S. Patents Issued: The United States Patent and Trademark Office has issued Iterum two new patents: 1) US Patent No. 11,478,428, directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses, and 2) US Patent No. 11,554,112 directed to the method of use of oral sulopenem in treating multiple diseases, including uncomplicated urinary tract infections. These U.S. patents are scheduled to expire no earlier than 2039, excluding any additional term for patent adjustments or patent term extensions. Existing patent protection for sulopenem etzadroxil is scheduled to expire in 2029, subject to potential extension. Iterum’s patent portfolio also contains pending patent applications outside the U.S., including Europe and China, submitted following receipt of the Written Opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive.
Shareholder Lawsuit Dismissed: On January 25, 2023, the putative class action lawsuit filed against Iterum, its Chief Executive Officer and Chief Financial Officer in the United States District Court for the Northern District of Illinois on August 5, 2021, was dismissed and cannot be brought back to court (dismissed with prejudice).
Fourth Quarter and Full Year 2022 Financial Results
Cash, cash equivalents and short-term investments were $60.8 million at December 31, 2022. Based on the current operating plan, Iterum expects that its current cash, cash equivalents and short-term investments will be sufficient to fund its operations until mid-2024. As of February 28, 2023, we had approximately 12.6 million ordinary shares outstanding.
Research and development (R&D) expenses for the fourth quarter and full year 2022 were $5.8 million and $17.6 million, respectively, compared to $3.7 million and $10.7 million for the same periods in 2021. The increase for the three-month period was primarily due to an increase in costs to support our REASSURE trial, which began enrollment in October 2022, partially offset by lower non-cash amortization of an intangible asset. The increase in R&D expenses for the full year was primarily due to the REASSURE trial, including an increase in headcount to support trial activities, partially offset by a decrease in consulting fees for R&D activities in 2022. Consulting fees for the year ending December 31, 2021 primarily related to consultants used during the FDA review of our NDA for oral sulopenem.
General and administrative (G&A) expenses for the fourth quarter and full year 2022 were $2.0 million and $12.8 million, respectively, compared to $3.1 million and $13.8 million for the same periods in 2021. The decrease for the three-month period was primarily due to a decrease in share-based compensation expense. The decrease for the full year period was primarily due to lower consulting fees used to support pre-commercialization activities versus the prior year, partially offset by an increase in compensation and headcount and an increase in legal fees associated with the lawsuit filed in August 2021 and dismissed with prejudice in January
2023.
Adjustments to the fair value of derivatives for the fourth quarter and full year 2022 were $3.0 million and $5.5 million, compared to $3.6 million and ($61.0) million for the same periods in 2021. The non-cash adjustment in the fourth quarter and full year 2022 primarily related to a decrease in the value of the derivative components associated with Iterum’s 6.500% Exchangeable Senior Subordinated Notes due 2025 (the “Exchangeable Notes”) as a result of a decrease in the price of its ordinary shares and market capitalization during the period. In addition, during the fourth quarter of 2022, a change in the discount rate impacted the fair value of the Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”). The non-cash adjustment in the fourth quarter of 2021 primarily related to a decrease in the value of the derivative components associated with the Exchangeable Notes as a result of a decrease in the price of its ordinary shares and market capitalization during the period. The non-cash adjustment for the full year 2021 was largely due to the fair value adjustments recorded at the time of conversion of $39.2 million of the Exchangeable Notes in 2021.
Cancellation of share options for the full year 2022 was $17.4 million and related to the non-cash charge in connection with employee share options that were surrendered and cancelled in July 2022.
Net loss for the fourth quarter and full year 2022 was $5.1 million and $44.4 million, respectively, compared to a net loss of $4.2 million and $91.6 million for the same periods in 2021. Non-GAAP1 net loss for the fourth quarter and full year 2022 of $6.4 million and $22.9 million, respectively, compared to a non-GAAP1 net loss of $3.3 million and $19.4 million for the same periods in 2021.
Conference Call Details
Iterum will host a conference call today, Thursday, March 16, 2023 at 8:30 a.m. Eastern Time. The dial-in information for the call is as follows: United States: 1 844 200 6205; International: 1 929 526 1599; Access code: 846586
About Iterum Therapeutics plc
swanlinbar
1 year ago
$ITRM >Iterum Therapeutics announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
December 15 2022 - 08:00AM
GlobeNewswire Inc.
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Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company” or “Iterum”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the United States Patent and Trademark Office (“USPTO”) has issued Iterum a Notice of Allowance for U.S. patent application number 16/372,075 entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” that covers the use of Iterum's candidate combination of sulopenem etzadroxil and probenecid in treating multiple diseases, including uncomplicated urinary tract infections.
“Following on from the patent recently issued by the USPTO directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid (“oral sulopenem”) and its related uses, we are very pleased to strengthen our oral sulopenem patent estate further with the addition of this new patent which, when issued, will afford protection until at least 2039 and further enhance its commercial opportunity. If approved, oral sulopenem will be the first oral penem available in the United States,” said Corey Fishman, Chief Executive Officer. “Enrollment in our pivotal Phase 3 clinical trial for oral sulopenem for the treatment of uncomplicated urinary tract infections is ongoing, and we expect to provide an update following an interim analysis at 50% patient enrollment.”
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after administrative processes are completed. The U.S. patent scheduled to issue from this application will expire April 1, 2039, absent any extensions. The recently issued U.S. patent for oral sulopenem entitled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof” also expires in 2039, absent any extensions.
The Company’s patent portfolio also contains pending patent applications outside the U.S. including Europe and China, submitted following receipt of the Written Opinion of the International Search Authority indicating that several claims directed to the composition of the bilayer tablet of oral sulopenem are novel and inventive.
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 Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and 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 Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
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