Neurosense, FDA to meet on Phase 3 plans for PrimeC in ALS
Nov. 6 meeting will include discussion on eventual approval
Neurosense Therapeutics will meet with the U.S. Food and Drug Administration (FDA) Nov. 6 to discuss plans for a Phase 3 trial to test its experimental therapy PrimeC in amyotrophic lateral sclerosis (ALS).
The company said it will give an update on results of the Type C meeting following receipt of official minutes, which usually takes about one month. The meeting will include discussions aimed at ensuring that Neurosense‘s strategy lines up with the FDA’s requirements for an eventual new drug application seeking approval of PrimeC, according to a company press release.
PrimeC is a fixed-dose combination of the antibiotic ciprofloxacin and the anti-inflammatory molecule celecoxib, both of which are individually approved for other indications. It’s thought that the combination may help to modulate several biological processes that are disrupted in ALS including inflammation, RNA processing, and iron accumulation.
Neurosense recently began the process of seeking approval of PrimeC for ALS in Canada. The company is seeking early marketing approval in Canada based mainly on findings from a Phase 2b clinical trial called PARADIGM (NCT05357950).
Disease progression slows, survival rates rise
The PARADIGM study involved 68 adults with ALS who were randomly assigned to take PrimeC or a placebo for about six months, in addition to the standard ALS treatment riluzole (sold as Rilutek, Tiglutik, and Exservan). After the six-month trial, almost all participants continued into an extension period in which all are receiving active treatment with PrimeC, taken twice daily as oral tablets.
Results from PARADIGM and its extension have shown that patients who started on PrimeC in the main trial had slower disease progression (by 36%) as well as significantly improved survival rates (by 43%) after one year, compared with patients who were first given a placebo and then received PrimeC in the extension.
Neurosense recently announced new biomarker data suggesting that PrimeC modulated the activity of microRNAs that have been implicated in ALS. MicroRNAs are small pieces of genetic material that act to regulate the activity of genes, helping cells to fine-tune which genes are activated or turned off. According to the company, there were clear differences in microRNA responses in the PrimeC and placebo groups in the PARADIGM trial.
“By restoring balance to these genetic regulators, PrimeC offers a new method of combating this devastating disease,” Neurosense said in a separate press release.
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