NeuroSense Therapeutics Ltd. (NRSN) announced on Wednesday that it is currently in advanced discussions with several multi-billion-dollar pharmaceutical companies regarding a potential strategic partnership to develop and commercialize its lead drug candidate, PrimeC, for Amyotrophic Lateral Sclerosis (ALS). These discussions, based on non-binding terms, could lead to substantial financial benefits for NeuroSense, including upfront payments, milestone payments, and royalty payments.
NeuroSense anticipates receiving concrete terms from these discussions in the fourth quarter of 2024. However, it’s important to note that there is no guarantee that a final agreement will be reached with any of the pharmaceutical companies, or what the final terms might be.
The potential partnership comes on the heels of promising results from NeuroSense’s PARADIGM Phase 2b study for PrimeC in ALS patients. In August, the company released 12-month iron biomarker data from the study, which demonstrated that PrimeC effectively targets iron regulation, a key factor in mitigating ALS disease progression and improving survival. These changes in iron metabolism align with the improved clinical outcomes observed in the study. Patients who received PrimeC maintained better functionality and survival rates compared to those on placebo.
In July, the company announced 12-month data from the PARADIGM Phase 2b study, which revealed significant improvements in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial. The analysis showed a difference of 6.5 points in the ALSFRS-R, representing a 36% improvement and a statistically significant P value of 0.009. Furthermore, participants on PrimeC demonstrated a 43% better survival rate than those initially on placebo.
Additional results from the PARADIGM Phase 2b study also highlighted the safety profile of PrimeC. The study showed a complication-free survival rate that was 57% higher for PrimeC compared to placebo after 12 months of treatment. This finding was even more pronounced in the pre-defined Per Protocol Population, where PrimeC demonstrated a 73% (p=0.02) difference in complication-free survival compared to placebo after 12 months of treatment.
NeuroSense Therapeutics’ focus on developing innovative treatments for ALS, combined with the promising results from its Phase 2b study, makes this potential partnership a significant development in the fight against this debilitating disease. The company’s efforts to secure a strategic partner could pave the way for the widespread availability of PrimeC as a potential treatment option for ALS patients.
