I don't love this-- I mean I deal with this alot in Bio... it does make the process easier when you are re formulating someone else's drug but what are you exactly licensing? Do you need to etc.
NeuroSense's PrimeC shows positive pharmacokineticic results in ALS 09/28 NRSN NeuroSense announced results from its multi-dose PK study of its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis, or ALS. It is expected that these PK data will assist NeuroSense in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements. PrimeC is a proprietary combination therapy and unique extended release formulation of two FDA approved drugs, celecoxib and ciprofloxacin. The study compared PrimeC to its reference products, co-administered celecoxib and ciprofloxacin, under an FDA-cleared IND. Results demonstrate that PrimeC's 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 further support the PrimeC dosing regimen used in the current PARADIGM trial.
I like Bios that 100% control their lead product.... like DICE.
NeuroSense's PrimeC shows positive pharmacokineticic results in ALS 09/28 NRSN NeuroSense announced results from its multi-dose PK study of its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis, or ALS. It is expected that these PK data will assist NeuroSense in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements. PrimeC is a proprietary combination therapy and unique extended release formulation of two FDA approved drugs, celecoxib and ciprofloxacin. The study compared PrimeC to its reference products, co-administered celecoxib and ciprofloxacin, under an FDA-cleared IND. Results demonstrate that PrimeC's 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 further support the PrimeC dosing regimen used in the current PARADIGM trial.
I like Bios that 100% control their lead product.... like DICE.
