Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PrimeC · 3 trials · 3 indications
Treatment emergent adverse event is any medical event associated with the drug
Number of subjects whose treatment is stopped prematurely for any reason
Number of patients whose treatment is stopped prematurely specifically due to adverse events
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 1.
Maximum measured plasma concentration over the morning 12-hour dosing interval on Day 7.
Area under the plasma concentration versus time curve from time zero to the end of the morning 12-hour dosing interval on Day 1, as calculated by the linear trapezoidal method.
Area under the plasma concentration time curve over the morning 12-hour dosing interval on Day 7, as calculated by the linear trapezoidal method.
AUC is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
AUC is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
Cmax is tested in order to assess the effect of food on the bioavailability of PrimeC-ER Tablets (748 mg) in healthy adult male and female subjects, and in order to evaluate the comparative bioavailability of PrimeC-ER Tablets (748 mg) relative to a 750 mg dose of ciprofloxacin tablets and a 200 mg dose of celecoxib capsules, when co-administered, under fasted conditions in healthy adult male and female subjects.
| Arm | Type | Description |
|---|---|---|
| PrimeC | ACTIVE_COMPARATOR | 2 tablets of PrimeC administered twice daily (4 tablets a day), at a daily dose of 1496 mg |
| Placebo | PLACEBO_COMPARATOR | 2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste. |
| Marketed ciprofloxacin and celecoxib | ACTIVE_COMPARATOR | 750 mg of ciprofloxacin and 200 mg of celecoxib, co-administered twice daily for 6.5 days following a meal |
| PrimeC ER Fasted | ACTIVE_COMPARATOR | Single dose PrimeC-ER (748 mg), administered following an overnight fast of at least 10 hours. |
| PrimeC ER Meal | ACTIVE_COMPARATOR | Single dose PrimeC-ER (748 mg), administered at 30 minutes after the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. |
| Name | Type | Description |
|---|---|---|
| PrimeC | DRUG | Ciprofloxacin and celecoxib combination extended release formulation |
| Placebo | DRUG | Placebo matches active drug in size, color and taste |
| PrimeC 748 mg | DRUG | PrimeC is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib |
| Ciprofloxacin 750 MG | DRUG | Ciprofloxacin |
| Celecoxib 200mg | DRUG | Celecoxib |
| PrimeC-ER 748 mg | DRUG | PrimeC-ER is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib |
Inclusion Criteria: 1. Able to comprehend and willing to sign an informed consent form (ICF) 2. Males or females between the ages of 18 and 75 years of age, inclusive 3. Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for a...
PrimeC is an investigational small molecule being developed for amyotrophic lateral sclerosis (ALS), a progressive neurological disease. It has also been studied in pharmacokinetics trials in healthy adult volunteers. NeuroSense Therapeutics is developing it as a potential treatment for ALS, and it holds an orphan drug designation from the FDA.
PrimeC is being developed by NeuroSense Therapeutics Ltd., a biotechnology company whose ticker symbol is NRSN. The company is advancing PrimeC as its lead candidate in neurology, with ALS as the primary indication under investigation.
PrimeC is in Phase 2 clinical development. Its lead trial, a Phase IIb study in ALS, has been completed. PrimeC is investigational and has not been approved by the FDA; it holds an orphan drug designation for its ALS program.
PrimeC has been evaluated in completed trials including NCT05357950, a Phase IIb double-blind, placebo-controlled ALS study with an open label extension that enrolled 69 subjects across Canada, Israel, and Italy. Pharmacokinetics studies NCT05436678 and NCT05232461 were also completed in healthy adult volunteers in the United States.