The neurodegenerative disease currently affects more than 200,000 people worldwide
NeuroSense Therapeutics has announced positive mid-stage results of its lead drug candidate, PrimeC, in people living with amyotrophic lateral sclerosis (ALS).
The phase 2b PARADIGM study has been evaluating PrimeC, a fixed-dose combination of two US 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 living with the neurodegenerative disease in Canada, Italy and Israel.
Affecting more than 200,000 people globally, ALS is a neurological disorder that affects the motor neurons, the nerve cells in the brain and the spinal cord that control voluntary muscle movement and breathing.
Previously granted Orphan Drug Designation by the FDA and the European Medicines Agency, PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid regulation to potentially inhibit the progression of ALS.
Results from the study showed that PrimeC demonstrated a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates in patients compared to placebo.
In addition, PrimeC-treated patients demonstrated better survival than those initially on placebo by 43% at 12 months, as well as a 63% improvement in the survival rate of participants compared to placebo.
“These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development,” said Merit Cudkowicz, chair of neurology and director of the Sean M. Healey and AMG Center for ALS, Massachusetts General Hospital.
Vivian Drory, head of the ALS clinic, Tel-Aviv Sourasky Medical Center, commented: “The promising results… highlight the significant potential of PrimeC as a disease-modifying drug for ALS [and]… underscore the importance of early intervention, which can lead to more substantial benefits and provide valuable insights that will inform the design of the company’s phase 3 study, increasing the likelihood of success.”

https://www.prnewswire.com/il/news-releases/neurosense-demonstrates-statistically-significant-efficacy-and-survival-benefits-in-people-living-with-als-the-promising-results-from-the-12-month-paradigm-study-highlight-primecs-potential-as-a-disease-modifying-drug-302186838.html