NeuroSense Therapeutics has released initial biomarker data from its Phase 2 RoAD study with the drug PrimeC in Alzheimer's patients. The study was designed as an exploratory proof-of-concept investigation and included only eight participants, three of whom completed a 12-month follow-up with plasma and cerebrospinal fluid samples.
In the plasma analysis, changes were observed in key Alzheimer's biomarkers such as brain-derived Tau?phospho-Tau and the amyloid-beta 42/40 ratio. Additionally, changes were observed in proteins typical of other neurodegenerative diseases, including alpha-synuclein and TDP-43. These proteins often occur as co-pathologies in Alzheimer's and are associated with a faster disease progression. Further changes involved biomarkers for oxidative stress and inflammation.
According to the company, the observed changes were directionally consistent with the assumed mechanism of action of PrimeC and resembled effects from previous studies in amyotrophic lateral sclerosis (ALS). The tolerability of PrimeC was described as favorable; no serious adverse events occurred.
The study was small and exploratory. Clinical efficacy endpoints were not investigated as a primary goal. The authors of the press release therefore emphasize that the results are preliminary and should be used to plan a larger, adequately powered study.
The available data provide indications of possible biological activity of PrimeC in Alzheimer's, but due to the very small sample size and the exploratory design, reliable conclusions regarding clinical efficacy or disease modification cannot currently be drawn. Further studies are needed to confirm the findings and to investigate whether the observed biomarker changes can translate into clinically relevant effects.
