Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PrimeC · 1 trial · 2 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
| 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. |
| Name | Type | Description |
|---|---|---|
| PrimeC | DRUG | Ciprofloxacin and celecoxib combination extended release formulation |
| Placebo | DRUG | Placebo matches active drug in size, color and taste |
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 oral small molecule therapy being developed for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It is not approved for any indication and remains in clinical development. NeuroSense Therapeutics is evaluating it as a potential disease-modifying treatment for people living with ALS.
PrimeC is being developed by NeuroSense Therapeutics Ltd., a clinical-stage biotechnology company that trades under the ticker NRSN. The company is advancing PrimeC as its lead candidate in neurology, specifically for amyotrophic lateral sclerosis, and holds an orphan drug designation from the FDA for this program.
PrimeC has completed a Phase 2b clinical trial in ALS. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency. NeuroSense Therapeutics has not yet reported a subsequent pivotal trial for the program.
PrimeC has been studied in one completed Phase 2b trial, NCT05357950, titled a Phase IIb, multi-center, multinational, double-blind, placebo-controlled study with an open label extension to evaluate safety, tolerability and efficacy in subjects with ALS. The trial enrolled 69 participants across Canada, Israel and Italy.
PrimeC has received orphan drug designation from the FDA for the treatment of amyotrophic lateral sclerosis. Orphan drug designation is granted to therapies intended for rare diseases affecting fewer than 200,000 people in the United States. It does not constitute approval, and PrimeC remains investigational.