NeuroSense Therapeutics has announced substantial advancements during the first half of 2025, marking a transformative period for the late-stage clinical biotechnology company as it progresses its novel treatment, PrimeC, for severe neurodegenerative diseases. This update underscores significant strides in clinical development, regulatory affairs, financial stability, and manufacturing readiness, all aimed at accelerating a potential breakthrough for amyotrophic lateral sclerosis (ALS) patients.

A pivotal highlight includes NeuroSense’s strategic navigation of regulatory pathways for PrimeC, its investigational combination therapy for ALS. Following constructive feedback from Health Canada, the company is preparing a revised submission to secure advanced consideration for PrimeC. Crucially, positive interactions with the U.S. FDA have paved the way for the planned initiation of a multinational Phase 3 clinical trial in ALS during the latter half of 2025, signaling a significant step toward market approval.

The first half of 2025 also saw NeuroSense achieve key corporate milestones, including regaining compliance with Nasdaq’s stockholders’ equity requirement. This financial strengthening, bolstered by a successful private placement in late 2024, has significantly enhanced the company’s balance sheet, providing a solid foundation for continued drug development and future commercialization efforts. Discussions for a definitive partnership agreement to advance PrimeC’s development and commercialization in key territories are also ongoing.

Further reinforcing PrimeC’s potential, new analyses from the completed 18-month Phase 2b PARADIGM study in ALS revealed compelling efficacy data. In participants who strictly adhered to the protocol, treatment with PrimeC remarkably slowed functional decline by approximately 40%. Furthermore, the data indicated a 74% improvement in overall survival, a 79% improvement in complication-free survival, and a 26% slower decline in slow vital capacity, collectively reinforcing PrimeC’s disease-modifying capabilities beyond standard ALS care.

Scientific validation of PrimeC’s mechanism and efficacy was further highlighted at the Annual Meeting of the American Academy of Neurology in April 2025. Members of NeuroSense’s scientific advisory board presented in-depth analyses from the PARADIGM study, with experts discussing safety, efficacy, and biomarker data. These presentations provided compelling evidence that PrimeC modulates microRNAs associated with ALS and impacts iron-related biomarkers, offering critical mechanistic insights consistent with the observed clinical improvements.

To ensure preparedness for potential commercialization, NeuroSense successfully scaled up PrimeC’s production to commercial levels in May 2025. The company validated the manufacturing process and selected a global contract development and manufacturing organization, confirming supply chain readiness. This critical operational milestone underscores NeuroSense’s foresight in ensuring the availability of PrimeC, supported by demonstrated product stability indicating a 36-month shelf-life.

Amyotrophic lateral sclerosis, an incurable neurodegenerative disease, presents one of the most significant unmet medical needs globally, leading to complete paralysis and often death within 2-5 years of diagnosis. With over 5,000 new diagnoses annually in the U.S. alone and a projected 24% increase in patients by 2040 across the U.S. and EU, the imperative for effective, disease-modifying treatments like PrimeC is more critical than ever.

PrimeC, NeuroSense’s lead drug candidate, is an innovative extended-release oral formulation comprising a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. Engineered to synergistically target multiple key mechanisms contributing to motor neuron degeneration in ALS, including inflammation, iron accumulation, and impaired RNA regulation, PrimeC holds the potential to significantly inhibit disease progression. Its efficacy and safety endpoints were previously met in a Phase 2a clinical trial, earning it Orphan Drug Designation from both the U.S. FDA and the European Medicines Agency.

NeuroSense Therapeutics is steadfast in its mission to discover and develop treatments for debilitating neurodegenerative diseases such as ALS, Alzheimer’s, and Parkinson’s. By focusing on combined therapies that target multiple pathways, the company aims to address these complex conditions, with the ultimate goal of rapidly bringing a meaningful and potentially life-altering treatment to individuals living with ALS and other severe neurological disorders.