NeuroSense Reports 20% ALS Patients Remain on PrimeC After 7 Years

NeuroSense Therapeutics reports that 20% of ALS patients from its Phase 2a study remain on PrimeC for over 5.5 years, with treatment well tolerated and no new safety signals observed. The patients have lived with ALS for over 7 years.

On August 19, 2025, Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced the publication of a retrospective analysis evaluating the long-term function and survival outcomes of ALS patients treated with RADICAVA ORS® (edaravone) compared to historical placebo controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. The study, published in the journal Muscle and Nerve, provides insights into the potential benefits of RADICAVA ORS in managing ALS.

The primary analysis, based on data from clinical studies MT-1186-A02/A04, evaluated 78 propensity score-matched patients treated with RADICAVA ORS and 78 matched historical placebo controls from the PRO-ACT database. The analysis showed evidence for a slowing of functional decline and improved survival outcomes with long-term RADICAVA ORS treatment. The main statistical comparison was made between the Combined (FDA approved On/Off + investigational Once Daily) RADICAVA ORS versus PRO-ACT placebo group.

Key findings from the analysis include:
- An association was observed between treatment with RADICAVA ORS and improved survival outcomes compared to matched historical placebo patients in the PRO-ACT database.
- In the primary analysis cohort, the combined RADICAVA ORS group demonstrated a survival benefit versus the PRO-ACT placebo group over approximately 22 months (P=0.005).
- The baseline risk-adjusted hazard ratio showed an 84% decreased risk of death, indicating a longer survival time, in the combined RADICAVA ORS versus PRO-ACT placebo groups (P=0.005).
- The post hoc broader ALS cohort showed a difference in time to death over approximately 35 months (P0.001).

The study also found a slower rate of decline in ALSFRS-R scores over 48 weeks with RADICAVA ORS treatment, suggesting potential benefits in maintaining physical function compared to matched PRO-ACT placebo group patients.

NeuroSense Therapeutics, in a separate study, reported that 20% of ALS patients from its Phase 2a study remained on PrimeC for over 5.5 years, with treatment well tolerated and no new safety signals observed. These patients had lived with ALS for over 7 years, indicating the potential long-term efficacy of PrimeC in managing ALS.

These findings contribute to the ongoing effort to address unmet needs in ALS treatment by providing insights into the benefits observed with RADICAVA ORS and PrimeC. However, it is important to note that results from these analyses are not generalizable and cannot be used to determine definitive conclusions about the effects of treatment. Further research is needed to validate these findings and assess the long-term impact of these treatments.

References:
[1] https://www.biospace.com/press-releases/mitsubishi-tanabe-pharma-america-announces-publication-of-long-term-function-and-survival-analysis-of-radicava-ors-edaravone-treated-patients-with-als