NeuroSense Therapeutics Ltd. announced results from its multi-dose PK study (NCT05436678) of its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS). It is expected that these PK data, combined with the current Phase IIb PARADIGM study, will assist NeuroSense in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with U.S. Food and Drug Administration (FDA) requirements. PrimeC is a proprietary combination therapy and unique extended release formulation of two FDA approved drugs, celecoxib and ciprofloxacin.

The randomized, multiple-dose, two-treatment, two-period crossover study compared PrimeC to its reference products, co-administered celecoxib and ciprofloxacin, under an FDA-cleared IND. In each period of the study, either two PrimeC tablets or co-administered ciprofloxacin and celecoxib were administered to 20 subjects every 12 hours for 6.5 days (13 total administrations) in fed conditions. The results of the study demonstrate that PrimeC's unique formulation resulted in a simultaneous release of ciprofloxacin and celecoxib under fed conditions, as compared to co-administration of the reference products.

In addition, the attained PK profile and bioavailability of PrimeC under steady state conditions (with drug concentrations consistently remaining within therapeutic limits for an extended period) further support the PrimeC dosing regimen used in the current PARADIGM trial. The data further demonstrated a clear safety profile for PrimeC under steady state conditions, as a comparison of PrimeC to ciprofloxacin and celecoxib shows that the Cmax, AUC0-t, and AUC0-8 are lower for both components of PrimeC compared to the highest approved doses of each of the components administered separately. Moreover, these findings indicate it would be appropriate to rely on safety data available for each of the approved reference drugs, ciprofloxacin and celecoxib, in a 505(b)(2) application pathway.

PrimeC, NeuroSense's lead drug candidate, a combination therapy for ALS, was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). NeuroSense completed a Phase IIa clinical study which successfully 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's upgraded formulation, which is a unique extended-release tablet, designed to maximize the synergism between the compounds, is now being evaluated in a Phase IIb clinical trial, PARADIGM, for the treatment of ALS.

About PARADIGM NeuroSense's Phase IIb PARADIGM trial is currently enrolling patients to assess PrimeC's efficacy, as well as safety and tolerability, in people living with ALS. The study is randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Primary endpoints of the study include assessment of ALS biomarkers, evaluation of clinical efficacy, improvement in quality of life, as well as safety and tolerability.

Topline data are expected mid-2023. 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 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion.

The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.