{"id":222942,"date":"2026-09-03T09:25:06","date_gmt":"2026-09-03T09:25:06","guid":{"rendered":"https:\/\/quixnet.net\/wpinstance\/revamped-plan-aims-to-hasten-us-approval-of-treatment-for-als-als-news-today\/"},"modified":"2026-09-03T09:25:06","modified_gmt":"2026-09-03T09:25:06","slug":"revamped-plan-aims-to-hasten-us-approval-of-treatment-for-als-als-news-today","status":"publish","type":"post","link":"https:\/\/quixnet.net\/wpinstance\/revamped-plan-aims-to-hasten-us-approval-of-treatment-for-als-als-news-today\/","title":{"rendered":"Revamped plan aims to hasten US approval of treatment for ALS – ALS News Today"},"content":{"rendered":"

Neurosense plans head-to-head trial of its Prime C against approved ALS drug
Written by \t\t\t\t\t\t\t \t\t\t\t\t\t\t\tMarisa Horak, MS<\/a> \t\t\t\t\t\t\t<\/span> \t\t\t\t\t\t\t|<\/span> \t\t\t\t\t\t\tNeurosense Therapeutics<\/a> is revamping its development plan for PrimeC, the company’s experimental oral therapy for amyotrophic lateral sclerosis<\/a> (ALS).
The updated plan includes a new study that will directly compare PrimeC against an approved ALS treatment<\/a>, as well as a restructured Phase 3 trial and analyses of existing data using artificial intelligence (AI). With these changes, Neurosense hopes to secure U.S. approval for PrimeC on a faster timeline than originally planned. The redesigned plan will also be cheaper, the company said.
“We have asked a straightforward question: what is the shortest reasonable route from the data we already hold to a therapy people can actually receive? This plan is our answer,” Alon Ben-Noon, co-founder and CEO of Neurosense, said in a company press release<\/a>.
Clinical trials \u2014 rigorously designed scientific studies with human participants \u2014 are the gold standard for evaluating the safety and effectiveness of experimental treatments. Typically, drug developers will initially conduct Phase 1 studies to evaluate preliminary safety, followed by Phase 2 studies to further assess safety and begin evaluating efficacy. If all goes well, developers will then move on to Phase 3 studies, which are typically large trials designed to definitively determine whether or not a treatment works.
In ALS, running a Phase 3 clinical trial usually takes at least a few years \u2014 which poses a major problem because most ALS patients do not survive longer than a few years after the onset of the disease.
“One of the hardest constraints in ALS is not scientific \u2014 it is that the standard development path takes longer than patients have,” Ben-Noon said.
PrimeC has already been tested in a Phase 2b trial called PARADIGM trial (NCT05357950)<\/a>, which enrolled 68 people with ALS. The study met its main goal, showing that PrimeC was more effective than a placebo at decreasing levels of TDP-43 protein<\/a> after six months. Nearly all ALS cases are marked by toxic clumps of TDP-43 protein that damage nerve cells and are thought to drive disease progression.
Data from PARADIGM and its yearlong open-label extension also hinted that PrimeC may slow disease progression<\/a> and extend survival<\/a>. Based on these data, Neurosense has announced plans to ask authorities in Canada to approve PrimeC<\/a> by year’s end.
Meanwhile, the company has been planning to launch a Phase 3 study, dubbed PARAGON, to further test PrimeC. The company had originally planned to do one long trial, as is typical, and the U.S. Food and Drug Administration (FDA) had already signed off<\/a> on those plans.
But now Neurosense is evaluating an alternative design for the Phase 3 study that would require fewer patients and generate results in a shorter time frame. It would involve preferentially enrolling patients who are early in the course of ALS. Neurosense noted that the plans are not finalized and that any changes are subject to FDA approval.
In parallel with the updated Phase 3 trial, Neurosense plans to launch a separate study that will directly test PrimeC against Radicava<\/a> (edaravone), an approved ALS therapy.
“Head-to-head trials are not common in ALS, and differentiated results could provide people with ALS, clinicians, payers and prospective partners with compelling evidence of PrimeC’s relative clinical value and commercial potential,” the company stated in the press release.
PrimeC is an extended-release oral tablet that contains the antibiotic ciprofloxacin and the anti-inflammatory celecoxib, both of which are already FDA-approved for use in other conditions. The therapy aims to dampen the inflammation believed to contribute to ALS progression.
Neurosense’s new plan for Prime C also includes AI-powered analyses of data from a completed clinical pharmacology study that are aimed at evaluating how its two active ingredients act together in the body. The company hopes these analyses will show that the fixed-dose combo of ciprofloxacin and celecoxib in PrimeC offers effects that can’t be achieved with other formulations of the medication’s individual components.
Overall, Ben-Noon said that this new plan “is faster, it costs less, and it produces a stronger package \u2014 pharmacology, comparative clinical context, and a pivotal dataset \u2014 than the single-trial approach would have.”
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