Neurosense Therapeutics (NRSN) Reports Positive PrimeC Pharmacokinetic Study Results, Plans Phase IIb ALS Enrollment to Expand into US

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today 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.

"With this additional multi-dose PK study, we have achieved another important milestone in our PrimeC ALS development plan. The results confirm the favorable safety and improved PK profile of PrimeC in this unique formulation," stated NeuroSense's Chief Medical Officer, Dr. Ferenc Tracik.

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-∞ 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.

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