ciprofloxacin/celecoxib (PrimeC) / NeuroSense Therap - LARVOL DELTA

NeuroSense Therapeutics Announces Successful Completion of Commercial Manufacturing Scale-Up for PrimeC in Preparation for Potential Canadian Market Launch (PRNewswire) - "NeuroSense Announces Global CDMO Selection and Manufacturing Scale-Up, Enabling Rapid Pathway to Commercialization for What is Projected to be a $100-150M Canadian Market Opportunity...NeuroSense Therapeutics...today announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study....NeuroSense has strategically bolstered its supply chain by implementing comprehensive Chemistry, Manufacturing, and Controls (CMC) enhancements that positions the company for a robust and expeditious commercial launch....'With commercial-scale production validated and a 36-month room-temperature shelf life confirmed, PrimeC is now positioned to rapidly enter the Canadian market upon regulatory approval. This achievement, coupled with our patent protection through 2042..."

Commercial • Patent • Amyotrophic Lateral Sclerosis

Elucidating the Synergistic Effect of the PrimeC Combination for Amyotrophic Lateral Sclerosis in Human Induced Pluripotent Stem Cell-Derived Motor Neurons and Mouse Models. (PubMed, Pharmaceuticals (Basel)) - " Our findings support the potential of combination therapy as an effective strategy for ALS treatment. Specifically, the PrimeC combination demonstrated promising therapeutic effects, providing a strong rationale for its ongoing development as a targeted treatment for ALS."

Journal • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders

NeuroSense Therapeutics Announces Transformative Phase 2b MicroRNA Data, Highlighting PrimeC's Promise as a Disease-Modifying ALS Treatment (PRNewswire) - P2b | N=69 | PARADIGM (NCT05357950) | Sponsor: NeuroSense Therapeutics Ltd.| "NeuroSense Therapeutics, Ltd...today announced promising new findings from its Phase 2b PARADIGM clinical trial. The data highlights the significant impact of PrimeC, the company's investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS), on microRNA (miRNA) modulation....In ALS patients treated with PrimeC, the study observed a profound and consistent downregulation of 161 mature miRNAs across all time points in the double-blind period. In contrast, no significant changes were detected in the placebo arm, emphasizing PrimeC's targeted biological activity and potential for disease modification....PrimeC treatment led to the significant downregulation of ALS-related miRNAs, including miR-199 and miR-181, both of which are associated with ALS disease progression and survival."

P2b data • Amyotrophic Lateral Sclerosis

MicroRNA Profiling and Iron-Related Modulation as Key Markers for Target Engagement in ALS Treatment with PrimeC (AAN 2025) - "Conclusions These findings demonstrate a significant effect of PrimeC on miRNA expression and iron regulation, highlighting the utility of our multimodal approach in disentangling treatment responses in ALS. These positive clinical and biomarker outcomes provide a solid foundation to progress to a Phase 3 trial."

Late-breaking abstract • Inflammation • MIR199A • MIR199A1

NeuroSense Therapeutics Reports Year End 2024 Financial Results and Provides Business Updates (PRNewswire) - "Ongoing partnership discussions to advance PrimeC to Phase 3 study in ALS and commercialization. Phase 3 study design for PrimeC in ALS aligned with FDA; planned initiation in 2025."

Commercial • New P3 trial • Amyotrophic Lateral Sclerosis

NeuroSense Therapeutics to Present New Data from PrimeC's Phase 2b Trial in ALS at the Annual American Academy of Neurology Meeting (PRNewswire) - "NeuroSense Therapeutics, Ltd...today announced that two members of its Scientific Advisory Board will present new data from the Company's Phase 2b trial during the General Neurology and Late Breaker sessions at the 77th Annual American Academy of Neurology (AAN) Meeting. The presentations and conference will be taking place in San Diego, CA on April 8, 2025."

P2b data • Amyotrophic Lateral Sclerosis

The therapeutic effect of the combination of ciprofloxacin and celecoxib of amyotrophic lateral sclerosis (ChiCTR) - P=N/A | N=60 | Not yet recruiting | Sponsor: Southern Medical University Southern Hospital; Southern Medical University Southern Hospital

New trial • Amyotrophic Lateral Sclerosis • CNS Disorders

THE ROAD TO HOPE: COMBINATION OF CIPROFLOXACIN & CELECOXIB AS A NOVEL THERAPEUTIC APPROACH FOR ALZHEIMER'S DISEASE (ADPD 2025) - "This study could potentially reveal a new therapeutic approach for halting AD progression through a multi -targeted strategy, and identify novel biomarkers for target engagement."

Alzheimer's Disease • CNS Disorders • Infectious Disease • Inflammation

SHIFTING THE PARADIGM: PRIMEC, AN ORAL CANDIDATE FOR AMYOTROPHIC LATERAL SCLEROSIS, DEMONSTRATES SAFETY, EFFICACY, AND TARGET ENGAGEMENT IN A 12-MONTH PHASE 2B TRIAL (ADPD 2025) - P2 | "The treatment slows disease progression, trended towards an improved survival rate, and effectively modulated iron metabolism, a key factor in ALS pathology. These Results support further investigation in a pivotal Phase 3 trial."

Clinical • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • NEFL

Market Alert: NeuroSense Therapeutics Advances Toward Early Canadian Commercialization of ALS Drug (Businesswire) - "Market News Alerts Reports: NeuroSense Therapeutics Ltd...has announced significant progress toward the early commercialization of PrimeC in Canada. According to a Form 6-K filed with the SEC this morning, Health Canada has invited the company to a pre-New Drug Submission (pre-NDS) meeting to discuss a potential Notice of Compliance/conditional (NOC/c) regulatory pathway for PrimeC as a treatment for Amyotrophic Lateral Sclerosis (ALS). NeuroSense is targeting potential approval in Canada by H1 2026. The company estimates peak annual revenue potential of $100-150M USD in the Canadian market...The drug has demonstrated promising results in clinical trials, including the Phase 2b PARADIGM study, which showed a 36% reduction in disease progression and 43% improvement in survival rates compared to placebo."

Canada approval • Sales projection • Amyotrophic Lateral Sclerosis

Shifting The PARADIGM: PrimeC, An Oral Candidate For Amyotrophic Lateral Sclerosis, Demonstrates Safety, Efficacy, And Target Engagement In An 18-Month Phase 2b Trial (AAN 2025) - P2 | "PrimeC demonstrated a statistically significant reduction in ALSFRS-R over 12 months, with a favorable safety and tolerability profile. PrimeC not only slows disease progression and suggests improved survival, but also effectively modulates ALS-related biomarkers, demonstrating strong target-engagement."

Clinical • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • MIR199A

NeuroSense Therapeutics Enters Binding Term Sheet to Advance PrimeC for ALS (PRNewswire) - "NeuroSense Therapeutics Ltd...announced today that it has entered into a binding term sheet with a leading global pharmaceutical company to advance the development and commercialization of PrimeC, its proprietary treatment drug for amyotrophic lateral sclerosis (ALS) in certain key territories. NeuroSense would retain full rights to PrimeC in other key territories.The binding term sheet outlines substantial financial terms from the pharmaceutical company, including: A substantial upfront payment upon signing a definitive agreement; Funding for the Phase 3 clinical trial; Regulatory and net sales milestone payments, and A tiered royalty structure reaching double-digit percentage on annual net sales. The binding term sheet is subject to finalization of a definitive agreement, anticipated in the first quarter of 2025."

Commercial • Amyotrophic Lateral Sclerosis

NeuroSense Provides Business Update and Third Quarter 2024 Financial Results (PRNewswire) - "Upcoming Corporate Highlights for H1 2025 include: i) Additional results from the 18-month Phase 2b PARADIGM study; ii) Meeting with EMEA...As such, NeuroSense has initiated the regulatory process to seek early commercialization approval for PrimeC under Health Canada. The Company expects to submit a dossier in Q2 2025, with a regulatory decision expected by Q1 2026."

Canada approval • Canada filing • European regulatory • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders

NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC (PRNewswire) - "NeuroSense Therapeutics Ltd...announced it has concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). The purpose of the meeting was to discuss the design of a proposed Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. The Company had a productive discussion with the FDA regarding the design of the planned Phase 3 pivotal study with PrimeC, including efficacy and safety measurements....In light of the FDA's feedback, NeuroSense plans to submit a final protocol to the FDA during the first half of 2025 with the aim of commencing enrollment of the pivotal Phase 3 study in mid-2025, which would include approximately 300 patients divided by a ratio of 2:1, PrimeC to placebo."

FDA event • New P3 trial • Amyotrophic Lateral Sclerosis

NeuroSense Announces Completion of PARADIGM Study Highlighting PrimeC's Significant Efficacy and Survival Benefits in ALS (PRNewswire) - P2b | N=69 | PARADIGM (NCT05357950) | Sponsor: NeuroSense Therapeutics Ltd. | "In participants who received PrimeC from the start of the 18-month study compared to those initially on placebo before transitioning to PrimeC, disease progression was slowed by 33% (p=0.007), demonstrated in a 58% improvement in survival rates; Consistent data across subgroups underscore the potential of PrimeC to redefine the standard of care in the treatment of ALS...The 18-month PARADIGM study results will be presented at the 2024 International Symposium on ALS/MND, taking place December 6-8, 2024...The Company anticipates to update on the outcome of the meeting with the FDA in the next several days."

FDA event • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders

NeuroSense Therapeutics to Participate in the 2024 International Symposium on ALS/MND (PRNewswire) - "NeuroSense Therapeutics Ltd...is pleased to announce its participation in the 2024 International Symposium on ALS/MND, to be held December 6-8, 2024, in Montreal, Canada. During the event, NeuroSense will present the latest findings from its Phase 2b PARADIGM trial of PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS)."

P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders

Shifting the PARADIGM: PrimeC, an oral candidate for Amyotrophic Lateral Sclerosis (ALS), demonstrates target engagement biomarkers in a 12-month, Phase 2b trial (ALS-MND 2024) - P2 | "In conclusion, these results demonstrate PrimeC's target engagement, particularly in reducing neuroinflammation and iron accumulation, and set the stage for a pivotal Phase 3 trial."

Biomarker • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders • Inflammation • NEFL • TARDBP

PrimeC, an oral candidate for ALS, demonstrates safety and efficacy in a 12-month Phase 2b trial (ALS-MND 2024) - P2 | "These results suggest that PrimeC is safe and may positively impact ALS clinical outcomes after 12 months, warranting a pivotal Phase 3 trial"

Clinical • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders

NeuroSense Secures Key FDA Meeting to Advance its Phase 3 ALS Trial and NDA Submission (PRNewswire) - "NeuroSense Therapeutics Ltd...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....In parallel, NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a regulatory decision anticipated by Q1 2026."

Canada approval • FDA event • Amyotrophic Lateral Sclerosis

New Analysis Shows PrimeC Significantly Improves Key miRNAs in ALS Patients (PRNewswire) - P2b | N=69 | PARADIGM (NCT05357950) | Sponsor: NeuroSense Therapeutics Ltd. | "NeuroSense...announced transformative findings from its PARADIGM clinical trial of PrimeC...Key Findings: Regulation of Critical miRNAs: The PARADIGM trial revealed that PrimeC regulates specific miRNAs - key genetic markers that control gene expression involved in ALS progression. These miRNAs were unchanged in the placebo group, underscoring the profound impact of PrimeC on ALS's pathological pathways....PrimeC enhances microRNA (miRNA) maturation, addressing the underlying mechanisms of ALS. By influencing Dicer, the endonuclease that processes precursor miRNA into active forms, PrimeC may restore the balance of dysregulated miRNAs in ALS patients. This modulation is thought to facilitate the production of functional miRNAs that regulate gene expression, allowing PrimeC to target disrupted genetic pathways in ALS and potentially slow disease progression and improve patient outcomes."

P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders

NeuroSense Advances Plans for Early Commercialization of Groundbreaking ALS Treatment in Canada, Provides Further Updates (PRNewswire) - "Dossier submission planned for Q2 2025; regulatory decision expected by Q1 2026...NeuroSense Therapeutics Ltd...provided a further update on its plans to file for early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This submission is based on promising results from the Company's Phase 2b ALS PARADIGM clinical trial, supported by additional clinical and preclinical data...NeuroSense estimates a significant market opportunity in Canada, with potential peak annual revenue of $100M to $150M, driven by the prevalence of ALS in Canada, estimated market penetration of PrimeC, estimated price, and the current unmet demand for effective ALS treatments."

Canada filing • Sales projection • Amyotrophic Lateral Sclerosis • CNS Disorders

NeuroSense Therapeutics Announces Acceptance of Two PrimeC Abstracts at the 2024 NEALS Annual Meeting (PRNewswire) - "NeuroSense Therapeutics Ltd...today announced the acceptance of two abstracts focusing on the company's lead drug candidate, PrimeC, for the treatment of Amyotrophic Lateral Sclerosis (ALS)...The abstracts will highlight groundbreaking data from NeuroSense's Phase 2b PARADIGM study. The first abstract, presenting clinical outcomes...The second abstract, focused on biomarker analysis..."

P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders

Shifting the Paradigm: PrimeC, an oral candidate for Amyotrophic Lateral Sclerosis, meets primary safety and secondary end points in the phase 2b trial with biomarker-driven focus (Neuroscience 2024) - P2 | "Given that microRNA regulation is one of the primary proposed mechanisms of action (MoA) of PrimeC, microRNA profiling will potentially delineate differentially expressed microRNAs, thereby reinforcing PrimeC’s MoA. In conclusion, these results suggest that PrimeC is safe and may have a positive impact on ALS outcomes, thereby warranting a Phase 3 pivotal trial."

Biomarker • Clinical • P2b data • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFL • TARDBP

NeuroSense Therapeutics Plans to File for Early Commercialization of ALS Treatment in Canada (PRNewswire) - "NeuroSense Therapeutics Ltd...announced it has initiated the regulatory process to seek early commercialization approval for PrimeC under Health Canada's Notice of Compliance with Conditions (NOC/c) policy. This submission is based on the promising results from the company's Phase 2b ALS PARADIGM clinical trial, alongside supporting clinical and preclinical data."

Canada filing • Amyotrophic Lateral Sclerosis

NeuroSense Therapeutics Granted Key U.S. Patent for Novel PrimeC Formulation, its Lead Asset for ALS and Alzheimer's (PRNewswire) - "NeuroSense Therapeutics...announced the issuance of a pivotal patent by the United States Patent and Trademark Office (USPTO). The newly granted patent, entitled 'Compositions comprising Ciprofloxacin and Celecoxib' (US Patent No. US 12,097,185), relates to the novel formulation of PrimeC, NeuroSense's leading drug candidate for the treatment of Amyotrophic Lateral Sclerosis (ALS). This patent is expected to extend PrimeC's patent protection by an additional four years, until 2042. PrimeC is composed of ciprofloxacin and celecoxib, two FDA-approved compounds in unique doses, formulated in a technology of slow release to synchronize their pharmacokinetic (PK) profiles and enhance their therapeutic synergy."

Patent • Alzheimer's Disease • Amyotrophic Lateral Sclerosis