PrimeC Oral Formulation Shows Promise as a Potential Treatment Candidate for ALS

According to new secondary endpoint data reported from the PARADIGM clinical trial (NCT05357950), PrimeC (ciprofloxacin/celecoxib; NeuroSense Therapeutics, Cambridge, MA), a novel, extended-release oral formulation drug candidate that combines ciprofloxacin and celecoxib, was shown to be associated with a clinically meaningful effect on quality of life and survival when used to treat people with amyotrophic lateral sclerosis (ALS). Additionally, data presented at the American Academy of Neurology (AAN) 2024 Annual Meeting demonstrate that people with ALS who were treated with PrimeC showed reductions in blood levels of neurofilament light chain (NfL).

PARADIGM was a phase 2b, randomized, multi-center, prospective, placebo-controlled study with an open label extension (OLE) evaluating the efficacy, tolerability, and safety of PrimeC for people with ALS. A total of 68 adult participants aged 18 to 75 years from the United States, Canada, Italy, and Israel with a diagnosis of familial or sporadic ALS were included. In the 6-month double-blind portion of the study, participants were randomly assigned to receive PrimeC or placebo.

According to the secondary outcome data reported by NeuroSense therapeutics, PrimeC met quality of life endpoints, which included measures of mental and physical health. Additionally, PrimeC was associated with a 53% reduction in ALS disease complications or death, as well as improvement in complication-free survival as measured by Milano-Torino staging (MiToS) and King’s staging systems compared with placebo.

After 6-months, there was an average 4.3% reduction in blood NfL levels for people in the entire study population receiving PrimeC relative to placebo. This reduction increased in significance for individuals who were treated closer to symptom onset.

• For individuals who were within 2 years of symptom onset, the average reduction was 3.6% relative to placebo.
• Within 1.5 years; 5.1%.
• Within 1 years; 17.2%.
• Within 9 months; 29.1%.

“The positive impact of PrimeC on quality of life and complication-free survival, together with its demonstrated ability to meaningfully slow down disease progression, is of great value, as we see that we have the potential to profoundly affect patients' lives across the board,” said Alon Ben-Noon, CEO of NeuroSense Therapeutics. “We are in great anticipation to soon report on the status of our collaboration on neurofilaments and how this may contribute to expediting the development of PrimeC.”