PrimeC, potential ALS treatment, given US patent for its formulation
Neurosense's candidate combines antibiotic and anti-inflammatory at fixed dose
Neurosense Therapeutics announced that it has received a U.S. patent covering the formulation of PrimeC, its lead investigational therapy for people with amyotrophic lateral sclerosis (ALS) that combines two approved medications in a fixed dose.
The patent, “Compositions comprising Ciprofloxacin and Celecoxib,” was issued by the United States Patent and Trademark Office and is expected to extend patent protections given to PrimeC until 2042.
The decision follows one-year findings in the ongoing PARADIGM Phase 2b trial (NCT05357950), showing that PrimeC significantly slowed ALS progression by 36%, while improving survival rates by 43% compared with a placebo.
PrimeC showing benefits with long-term use in Phase 2b extension study
One full year of treatment also was reported to slow lung function decline relative to patients who started with PrimeC after six months on a placebo in the main trial. A better regulation of iron in cells, as assessed by changed levels of two biomarkers of iron metabolism, also was seen with a year of treatment in the study’s extension phase. An overload of iron in nerve cells is thought to drive cellular damage and contribute to ALS progression.
“PrimeC is more than a combination of two [U.S. Food and Drug Administration]-approved compounds — it’s an innovative formulation that synchronizes their pharmacokinetics to unleash their full therapeutic potential,” Alon Ben-Noon, Neurosense’s CEO, said in a company press release. Pharmacokinetics refers to the movement of a medicine into, through, and out of the body.
PrimeC is an oral, fixed-dose combination of ciprofloxacin, an antibiotic, and celecoxib, an anti-inflammatory, that’s also formulated for extended release in the body. It is designed to slow disease progression by targeting cellular processes implicated in neurodegeneration, inflammation, iron accumulation, and to regulate the synthesis of microRNA, small noncoding RNA molecules that modulate gene activity, the company reports.
“The synergy between ciprofloxacin and celecoxib is designed to maximize efficacy, pushing the boundaries of what’s possible in ALS treatment,” Ben-Noon said.
Most patients who finished PARADIGM trial reported to continue on therapy
The PARADIGM trial is assessing PrimeC’s safety and early efficacy in 68 adults, who were randomly assigned in its main phase to PrimeC or placebo tablets, taken twice daily for six months. Most, 96% of participants, then moved into the study’s open-label extension, in which all are being given PrimeC for a year. The trial is due to conclude in November.
All who completed these two trial parts as of June have requested to continue on PrimeC, being provided in an investigator-initiated trial it is not time-limited, the company reported.
Neurosense has noted that a Phase 3 trial of PrimeC in a larger ALS patient group is being planned.
Most PARADIGM participants also were taking riluzole, marketed for ALS as Exservan, Rilutek (generics available), and Tiglutik. According to the company, this indicates that PrimeC may maximize the benefit of riluzole at slowing disease progression.
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