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 small molecule being developed for amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease. It has been studied in a Phase 2b clinical trial for ALS, and it has also been evaluated in pharmacokinetic studies in healthy volunteers. PrimeC has received orphan drug designation from the FDA.
PrimeC is a combination of two approved drugs, ciprofloxacin and celecoxib. It is thought to work by targeting multiple pathways involved in ALS, including reducing neuroinflammation and modulating RNA processing. The exact mechanism of action is not fully understood, but it is believed to have a synergistic effect in slowing disease progression.
PrimeC is being developed by NeuroSense Therapeutics Ltd., a biopharmaceutical company focused on developing treatments for neurodegenerative diseases. NeuroSense Therapeutics is publicly traded on the Nasdaq under the ticker symbol NRSN.
PrimeC has completed a Phase 2b clinical trial for ALS. The trial was a multi-center, multinational, double-blind, placebo-controlled study with an open-label extension. The drug is still in clinical development and is not yet approved by the FDA for any indication.
PrimeC has been studied in two completed clinical trials. The main efficacy trial is NCT05357950, a Phase 2b study in patients with ALS. Additionally, two Phase 1 pharmacokinetic studies, NCT05232461 and NCT05436678, were conducted in healthy volunteers to evaluate the drug's absorption and bioavailability.
PrimeC is a fixed-dose combination of ciprofloxacin and celecoxib, two existing drugs. It is not the same as either drug alone, but rather a proprietary combination being developed specifically for ALS. The combination is designed to provide a synergistic effect that may be more effective than either drug alone.