NeuroSense Secures U.S. Patent for PrimeC, Lead ALS and Alzheimer's Treatment

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN), a biotechnology firm in the late stages of clinical development, has announced a significant development in its efforts to combat severe neurodegenerative diseases. The United States Patent and Trademark Office (USPTO) has granted a crucial patent for NeuroSense's leading drug candidate, PrimeC, intended to treat Amyotrophic Lateral Sclerosis (ALS). The new patent, titled "Compositions comprising Ciprofloxacin and Celecoxib" (US Patent No. US 12,097,185), extends the drug's intellectual property protection by an additional four years, now covering it until 2042.

PrimeC is a novel formulation combining ciprofloxacin and celecoxib, two FDA-approved drugs, in unique doses. This combination is designed for slow release to synchronize their pharmacokinetic profiles, maximizing their therapeutic efficacy in slowing the progression of ALS. Recent clinical findings underscore PrimeC's potential; the drug demonstrated a 36% reduction in disease progression and a 43% improvement in survival rates compared to a placebo.

NeuroSense's CEO, Alon Ben-Noon, highlighted the innovative nature of PrimeC, stating that it is more than just a combination of two existing drugs. The formulation's ability to synchronize the pharmacokinetics of ciprofloxacin and celecoxib unleashes their full therapeutic potential, offering a significant leap forward in ALS treatment.

Amyotrophic lateral sclerosis (ALS) is a devastating neurodegenerative disease characterized by rapid progression to complete paralysis and death typically within 2-5 years of diagnosis. Annually, over 5,000 new cases are diagnosed in the United States, with the disease burden exceeding $1 billion. The prevalence of ALS is expected to rise by 24% by 2040 in the U.S. and the EU.

The progression of ALS is commonly tracked using the ALS Functional Rating Scale-Revised (ALSFRS-R). This scale, widely accepted by the FDA and used in clinical trials, monitors changes in physical abilities over time, assessing functions such as speech, walking, and breathing. A single point change on the ALSFRS-R can significantly impact a patient’s quality of life, such as transitioning from independent to assisted feeding.

NeuroSense is also conducting a Phase 2b clinical trial named PARADIGM to further evaluate PrimeC. This multinational, randomized, double-blind, placebo-controlled study involves 68 ALS patients from Canada, Italy, and Israel. Remarkably, 96% of participants who completed the 6-month double-blind portion opted to continue with a 12-month open-label extension. The trial's preliminary data revealed a 29% difference in favor of PrimeC over the placebo in slowing disease progression, with a statistically significant 37.4% improvement in ALSFRS-R scores.

PrimeC targets multiple mechanisms implicated in ALS, including motor neuron degeneration, inflammation, and iron accumulation. NeuroSense has completed a Phase 2a clinical trial, meeting safety and efficacy endpoints and showing positive changes in ALS-related biological markers.

NeuroSense Therapeutics is dedicated to developing treatments for neurodegenerative diseases like ALS, Alzheimer's, and Parkinson's. These diseases represent a significant unmet medical need, with limited effective treatments currently available. Based on extensive scientific research, NeuroSense's strategy involves developing combined therapies targeting multiple disease pathways.

NeuroSense remains committed to advancing its research and providing new treatment options for patients suffering from debilitating neurodegenerative conditions, aiming to bring innovative solutions to the forefront of medical science.