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NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. These diseases encompass Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease, and Parkinson's disease, among others.
The company's flagship product, PrimeC, is a novel extended-release oral formulation, combining ciprofloxacin and celecoxib in a specific ratio designed for synergistic effect. PrimeC aims to target several key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. The formulation has shown promising results in clinical trials, including a significant slowing of disease progression in Phase 2b studies.
In their recent PARADIGM Phase 2b clinical trial, NeuroSense demonstrated compelling data with a 37% reduction in the progression of ALS, with further subgroup analysis showing even higher efficacy in specific patient populations. This trial's success propelled the company towards preparing for a Phase 3 pivotal trial, with extensive collaboration and validation from industry experts.
NeuroSense has been active in forming strategic partnerships to enhance its research and development capabilities. Notable collaborations include agreements with Lonza for biomarker development, and Genetika+ for Alzheimer's disease drug development. These partnerships leverage cutting-edge technologies to optimize clinical outcomes and advance the company's therapeutic solutions.
Financially, NeuroSense reported an increase in R&D expenses from $6.4 million in 2022 to $7.6 million in 2023, reflecting its investment in expanding its workforce and clinical programs. Conversely, general and administrative expenses saw a decrease, contributing to an efficient allocation of resources. As of December 31, 2023, the company had a cash position of approximately $2.6 million.
With multiple ongoing projects and a robust pipeline, NeuroSense is set to play a significant role in addressing the unmet medical needs in neurodegenerative diseases. The company's dedication to advancing research and developing novel therapies positions it as a key player in biotech innovation.
For more information, visit NeuroSense's investor relations website at https://neurosense.investorroom.com/.
NeuroSense Therapeutics (NASDAQ: NRSN) has received approval from Italy's Medicines Agency (AIFA) to enroll patients in its Phase 2b clinical trial, PARADIGM, for ALS treatment with lead candidate PrimeC. This trial is also ongoing in Israel and has FDA clearance for recruitment in the U.S. The study will randomize 69 ALS patients to receive either PrimeC or placebo, assessing efficacy and safety over 6 months. PrimeC aims to mitigate ALS's motor neuron degeneration using a novel drug combination. This milestone expands patient access to potentially beneficial treatment options.
NeuroSense Therapeutics has received FDA clearance to enroll patients in the U.S. for its Phase 2b PARADIGM study of PrimeC, a novel combination therapy for ALS. Following successful pharmacokinetic studies, PrimeC targets key ALS mechanisms and includes two FDA-approved drugs. The study aims to enroll 69 patients to assess PrimeC's efficacy, safety, and tolerability. NeuroSense anticipates starting U.S. enrollments soon and aims to complete enrollment and announce results by mid-2023, leveraging its Orphan Drug Designation from the FDA and EMA.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) announced its participation in three major conferences focusing on neurodegenerative diseases. Key presentations include:
- At the NEALS Meeting (Nov 1-3, Clearwater Beach, FL), Dr. Ferenc Tracik will discuss the Phase IIb PARADIGM study and Dr. Shiran Zimri will present biomarker research.
- During Neuroscience 2022 (Nov 12-16, San Diego, CA), Dr. Zimri will explore PrimeC's potential for ALS treatment.
- The International Symposium on ALS/MND (Dec 6-9, Virtual) will feature Dr. Zimri presenting NeuroSense's clinical plans.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) has announced its participation in the BIO-Europe Partnering Conference taking place from October 24-26, 2022, in Lepzing, Germany. The company's VP of Business Development, Nedira Salzman Frenkel, will engage with potential partners in the CNS space to explore collaboration opportunities. Concurrently, Dr. Niva Russek Blum, VP Discovery & IP Generator, will assess assets from various institutions focusing on neurological conditions. NeuroSense is dedicated to developing therapies for severe neurodegenerative diseases, such as ALS and Alzheimer's.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) provided a Q3 update, highlighting advancements in its Phase IIb study for PrimeC, a drug designed for ALS. The company achieved enrollment milestones with over one-third of patients enrolled and aims for completion by late 2022. They also established collaborations to enhance ALS diagnostics and presented significant findings at key scientific conferences. With over $9 million in cash, NeuroSense is positioned to continue its clinical development. CEO Alon Ben-Noon acknowledged ALS community advancements and expressed gratitude to stakeholders.
NeuroSense Therapeutics (NASDAQ: NRSN) is set to participate in the Nasdaq Opening Bell Ceremony on October 13, 2022. CEO Alon Ben Noon will lead the event, celebrating the company's achievements since going public. NeuroSense will also host The ALS Combination Therapy Summit, discussing critical ALS topics and featuring prominent thought leaders. The company’s Phase IIb PARADIGM trial for its lead drug candidate, PrimeC, is currently enrolling patients, with top-line data expected mid-2023. The ALS disease burden is significant, with over 5,000 new cases annually in the U.S.
NeuroSense Therapeutics (NASDAQ: NRSN) announced participation in the Cantor Fitzgerald Neurology and Psychiatry Conference on October 6-7, 2022, in San Francisco. CEO Alon Ben-Noon will join a panel on ALS, while Prof. Jeremy Shefner will be a keynote speaker. The company's lead drug, PrimeC, is in a Phase IIb trial aimed at treating ALS, with topline data expected in mid-2023. PrimeC has already demonstrated safety and efficacy in previous trials, and has received Orphan Drug Designation from the FDA and EMA.
NeuroSense Therapeutics (NRSN) announced positive results from a multi-dose pharmacokinetic (PK) study of its lead drug candidate PrimeC, targeting amyotrophic lateral sclerosis (ALS). The study demonstrated PrimeC's extended release properties and favorable safety profile, supporting its ongoing Phase IIb PARADIGM trial. PrimeC, a combination of celecoxib and ciprofloxacin, has shown effective simultaneous release and bioavailability, reinforcing its dosing regimen. The company anticipates pivotal Phase III trial design to align with FDA requirements based on these findings.
NeuroSense Therapeutics (Nasdaq: NRSN) announced its participation in two conferences focused on amyotrophic lateral sclerosis (ALS). Presentations will cover the efficacy of PrimeC, its lead drug candidate, in the Phase IIb PARADIGM trial, with primary endpoints including ALS biomarkers. The TRICALS Consortium Masterclass in the Netherlands (September 28-30) and ALS ONE's 5th Annual Symposium (October 6-7, 11) will feature updates from the company's experts. Topline results from the trial are expected in H1 2023.
NeuroSense Therapeutics announced positive results from its GLP toxicology study for PrimeC, a combination therapy for ALS. The study confirmed PrimeC's safety at doses over four times the maximal clinical dose, supporting the current Phase IIb PARADIGM trial design. This follows encouraging outcomes from a prior Phase IIa study. The PARADIGM trial aims to assess the efficacy and safety of PrimeC in ALS patients, with topline data expected in H1 2023. This milestone enhances the likelihood of favorable clinical outcomes and supports the drug's development strategy.
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