This neurodegenerative disease currently affects more than 200,000 people worldwide.
Neurosense Therapeutics announced positive mid-stage results for its lead candidate, Prime C, in patients with amyotrophic lateral sclerosis (ALS).
The Phase 2b PARADIGM study is evaluating PrimeC, a fixed-dose combination of two U.S. Food and Drug Administration (FDA)-approved drugs — Bayer’s ciprofloxacin, a well-known antibiotic, and Pfizer’s Celebrex (celecoxib), a COX inhibitor used to treat inflammation — in 68 people with neurodegenerative diseases in Canada, Italy and Israel.
ALS, which affects more than 200,000 people worldwide, is a neurological disease that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing.
PrimeC, which previously received orphan drug designation from the FDA and the European Medicines Agency, is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and ribonucleic acid dysregulation, potentially inhibiting ALS progression.
Results of the study showed that PrimeC demonstrated significant improvements in patients’ ALS Functional Rating Scale-Revised (ALSFRS-R) score reduction and survival rates compared to placebo.
Additionally, patients treated with PrimeC were 43% more likely to survive at 12 months than those who initially received a placebo, resulting in a 63% improvement in participants’ survival compared to placebo.
“These intriguing long-term results indicate that study participants experienced a slowing of progression over time with PrimeC compared to the ALSFRS-R, the gold standard measure currently used in ALS drug development,” said Merritt Kudkowitz, M.D., Ph.D., chair of neurology at Massachusetts General Hospital and director of the Sean M. Healy and AMG ALS Center.
Vivian Drory, Head of the ALS Clinic at Tel Aviv Sourasky Medical Center, commented: “The encouraging results highlight the great potential of PrimeC as a disease-modifying treatment for ALS and underscore the importance of early intervention, which can lead to greater benefit, providing valuable insights to help design the company’s Phase 3 trial, improving its chances of success.”
