Ciprofloxacin

Meeting discussion to focus on finalizing Phase 3 study design and NDA readiness, ensuring a clear regulatory path for submission based on trial success Parallel preparations in Canada: NeuroSense plans to submit its dossier in Q2 2025, with a regulatory decision on commercialization expected by Q1 2026 CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it is scheduled for a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of its upcoming Phase 3 clinical trial for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS). The FDA Type C meeting, scheduled for November 6, 2024, will focus on finalizing the design of the Phase 3 trial, a pivotal step toward securing approval for the drug. NeuroSense will also review its readiness for a future New Drug Application (NDA) submission, ensuring its regulatory strategy aligns with the FDA's requirements. NeuroSense plans to give an update on the results of the meeting following receipt of the meeting minutes which are expected approximately one month after the meeting. PrimeC, NeuroSense's lead product, has shown promising results in clinical trials, including a statistically significant reduction in disease progression clinical and biological markers. With an urgent unmet need in ALS, NeuroSense is positioning PrimeC as a potential breakthrough therapy. In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026. The Company estimates the potential market opportunity for PrimeC in Canada alone to be approximately $100 million to $150 million in annual revenue. This decision follows the recommendations of Canadian regulatory experts and recent clinical findings, which demonstrated that PrimeC significantly reduced disease progression (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough therapy for ALS. About ALS Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU. About ALSFRS-R Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator. About PARADIGM PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time. As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug. About PrimeC PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency. About NeuroSense NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings and regulatory decisions, the market opportunity in Canada and securing regulatory approval in global markets. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; that the market opportunity in Canada will not be as currently estimated; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of Neurosense; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law. Logo - SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

iStock, hapabapa Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders. The FDA on Friday signed off on Iterum Therapeutics’ oral antibiotic sulopenem etzadroxil and probenecid, which will now be marketed as Orlynvah, for the treatment of uncomplicated urinary tract infections in adult women. Orlynvah, Iterum’s first FDA-approved product, is cleared for three designated microorganisms— Escherichia coli , Klebsiella pneumoniae and Proteus mirabilis —and is indicated for women with limited or no available alternative oral antibiotic options. Iterum CEO Corey Fishman in a statement called Orlynvah’s approval a “historic milestone” that “offers new hope for patients suffering from difficult-to-treat uUTIs (uncomplicated urinary tract infections).” Orlynvah is “the first oral penem approved in the U.S.,” Fishman said, noting it is “an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians.” To bring Orlynvah to the market and boost its commercialization efforts, Iterum will “renew” its “efforts to achieve a strategic transaction involving Orlynvah with the goal of maximizing value for our stakeholders,” Fishman said. The FDA’s decision on Friday was backed by Iterum’s clinical data for Orlynvah, including two Phase III trials. In the pivotal late-stage REASSURE study, topline data which were released in January 2024 , the oral sulopenem showed statistical non-inferiority to Augmentin (amoxicillin/clavulanate) in terms of overall response. Orlynvah significantly outperformed Augmentin at overall treatment success. Safety outcomes were comparable between treatment groups. Iterum’s data package also included findings from the pivotal Phase III SURE 1 study, which in June 2020 showed that the oral sulopenem was better than ciprofloxacin in patients with quinolone-resistant infections. SURE 1 also found Orlynvah to be safe, with adverse events developing at a comparable frequency as in the ciprofloxacin-treated group. Iterum filed a New Drug Application to the FDA but failed to secure approval. In July 2021, the regulator handed the Dublin, Ireland-based biotech a Complete Response Letter, noting that while SURE 1 had established that oral sulopenem was superior than ciprofloxacin, Iterum would need to run an additional trial that uses a different comparator drug. Iterum filed its resubmission earlier this year, after which the FDA convened its Antimicrobial Drugs Advisory Committee. The panel was not asked to vote on the approvability of Orlynvah, but Fishman said in a statement after the meeting that the company was “encouraged” by the discussion, “which acknowledged oral sulopenem as an important treatment option for certain patients with uUTI.”