Novel ALS Treatment Candidate PrimeC Shows Promise in Phase IIb Trial

Novel ALS Treatment Candidate PrimeC Shows Promise in Phase IIb Trial

A groundbreaking treatment option for amyotrophic lateral sclerosis (ALS) has shown positive results in the phase IIb PARADIGM trial. Developed by NeuroSense Therapeutics, PrimeC is a unique formulation containing ciprofloxacin and celecoxib, both of which are FDA-approved drugs. The results of this trial were presented by Merit Cudkowicz, MD, MSc from Massachusetts General Hospital at the American Academy of Neurology annual meeting.

Safety and Efficacy

In this trial, ALS patients who were treated with PrimeC demonstrated similar safety profiles to those who received a placebo. The trial also measured the ALS Functional Rating Scale-Revised (ALSFRS-R) scores which seemed to favor PrimeC at the 6-month mark. While the adjusted ALSFRS-R scores difference was not significant in an intention-to-treat analysis, a per-protocol analysis showcased a statistically significant difference in favor of PrimeC. The treatment targets several key pathological mechanisms of ALS including neuroinflammation, iron accumulation, and dysregulation of microRNA metabolism.

The PARADIGM trial included ALS patients, both familial and sporadic, who were randomized to receive either PrimeC or a placebo. The trial was conducted in Canada, Italy, and Israel over a period of 6 months. The participants in both groups had an upright slow vital capacity (SVC) of at least 60% at the start of the trial. The primary endpoint of the trial was safety and tolerability, with results indicating that PrimeC was well-tolerated with most participants completing the trial on medication.

Celecoxib, one of the components of PrimeC, works on inflammation while ciprofloxacin regulates microRNA and iron accumulation. Previous studies had shown that celecoxib, when used alone, did not produce benefits in ALS patients. However, the combination of celecoxib and ciprofloxacin in PrimeC seems to have a more positive impact on disease progression.

Clinical Outcomes

The results of the trial suggest that PrimeC may have a positive effect on ALS clinical outcomes, with a significant slowing of disease progression seen in the per-protocol population. This has paved the way for a potential phase III pivotal trial to further evaluate the efficacy of PrimeC in treating ALS. Further analysis of biomarkers such as TDP-43 and prostaglandin 2 may provide additional insights into the clinical results.

In addition to ALS, PrimeC is also being studied in Parkinson’s disease and Alzheimer’s disease. The phase II Alzheimer’s study is currently underway, raising hopes for the development of new treatment options for these neurodegenerative conditions.

The results of the PARADIGM trial have shed light on the potential of PrimeC as a novel treatment candidate for ALS. With its favorable safety profile and promising clinical outcomes, PrimeC offers new hope for patients suffering from this devastating disease. Further research and clinical trials will be crucial in determining the full extent of PrimeC’s efficacy and establishing it as a future standard of care for ALS patients.

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