NeuroSense has shared new biomarker data from the Phase IIb PARADIGM study, showing that its amyotrophic lateral sclerosis (ALS) drug PrimeC (celecoxib and ciprofloxacin) regulated iron levels at 12 months.
ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, leading to muscle weakness and paralysis, and is eventually fatal. The association between iron levels and ALS is significant because abnormal iron metabolism is thought to contribute to the disease’s progression.
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This data builds on previously announced results from the PARADIGM study (NCT05357950). At 12 months, disease progression was slowed by 36% in participants who received PrimeC compared to those who initially received a placebo. Additionally, participants on PrimeC demonstrated 43% better survival than those initially on placebo, at 12 months.
The data from the trial suggests that PrimeC could be a disease-modifying drug for ALS, said the company. Regulating iron levels might help mitigate disease progression and improve survival rates in ALS patients.
The company is now planning a Phase III trial, which is set to begin later this year. In May 2024, NeuroSense teamed up with US-based company PhaseV to develop the Phase III trial protocol. The partnership aims to utilise PhaseV’s expertise in causal machine learning (ML) for clinical trial analysis and optimisation.
Prime C is an oral fixed-dose formulation of two US Food and Drug Administration (FDA) approved drugs – celecoxib, a non-steroidal anti-inflammatory (NSAID), and ciprofloxacin, a broad-spectrum antibiotic. PrimeC activates DICER and inhibits COX-2—two enzymes linked to ALS through their involvement in neuroinflammation and microRNA (miRNA) dysregulation, which are common features of the disease.
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By GlobalDataThe drug secured an orphan drug designation for its potential as a treatment for ALS from the FDA and the European Medicines Agency (EMA) in 2020 and 2021, respectively. PrimeC is also being investigated as a treatment for Alzheimer’s disease, with a Phase II trial (NCT06185543) set to conclude next year.
Developing disease-modifying treatments for ALS has proved challenging due to the complex pathophysiology of the disease, and ALS clinical trials typically have a high failure rate. In April 2024, Amylyx axed its ALS drug Relyvrio (AMX0035), following disappointing Phase III results.
In the announcement accompanying the data, Merit Cudkowicz, chair of neurology and director of the Sean M Healey & AMG Center for ALS at Massachusetts General Hospital, said: “This new analysis highlights PrimeC’s ability to regulate the iron panel in people living with ALS, underscoring the drug’s target engagement. These findings strongly support the proceeding to Phase III testing of PrimeC in ALS.”
