- NeuroSense Therapeutics collaborates with PhaseV to optimize the upcoming Phase 3 trial of PrimeC for ALS treatment.
- PhaseV’s causal machine learning analysis predicts high success rates across multiple patient subgroups.
- Positive efficacy and safety data from the Phase 2b trial positions PrimeC as a promising ALS treatment.
- NeuroSense plans to submit Phase 2 findings to regulatory agencies, including updated Phase 3 study protocols.
Main AI News:
In a strategic move aimed at refining the forthcoming Phase 3 trial of PrimeC for amyotrophic lateral sclerosis (ALS), NeuroSense Therapeutics has forged a partnership with PhaseV, a leading expert in leveraging causal machine learning (ML) for clinical trial enhancement. This collaboration underscores NeuroSense’s commitment to pioneering treatments for severe neurodegenerative diseases.
PhaseV’s independent analysis of NeuroSense’s PARADIGM Phase 2b study, employing causal ML techniques, has yielded promising insights. The analysis forecasts a high likelihood of success across multiple subgroups in the planned Phase 3 trial of PrimeC for ALS treatment. These findings are invaluable, providing crucial guidance for study design, patient recruitment strategies, and cost-efficiency measures.
“There’s an urgent demand for innovative solutions to combat the challenges posed by neurodegenerative diseases,” remarked Alon Ben-Noon, CEO of NeuroSense. “Our recent subgroup analysis from the PARADIGM study is encouraging, hinting at PrimeC’s potential to reshape the treatment landscape. Through our collaboration with PhaseV, we’ve gained deeper insights into PrimeC’s impact across diverse patient subsets. Armed with these insights, we’re poised to optimize our Phase 3 trial design, aiming for robust clinical outcomes that position PrimeC as a market differentiator. We anticipate continued collaboration with PhaseV throughout our Phase 3 trial development.”
NeuroSense’s recent disclosure of positive efficacy and safety data from the PARADIGM Phase 2b trial sets the stage for advancing PrimeC into a Phase 3 pivotal trial in the near future. PrimeC showcased a statistically significant 37% deceleration in disease progression, as measured by the ALSFRS-R score (p=0.03), in the per-protocol population. Notably, in high-risk ALS patients, PrimeC exhibited a compelling 43% reduction in disease progression compared to placebo (p=0.02) in the pre-specified per protocol (PP) population analysis after six months of treatment. This translates to a clinically significant 5.04-point gap in the ALSFRS-R score favoring PrimeC (Confidence Interval: 0.862, 9.214; n=38). High-risk patients, constituting roughly 50% of the total ALS population, stand to benefit substantially.
NeuroSense is gearing up to submit its End of Phase 2 dossier to the FDA and EMA, inclusive of the updated Phase 3 study protocol, slated for deliberation in upcoming regulatory meetings.
Dr. Raviv Pryluk, CEO and Co-founder of PhaseV, emphasized, “Despite advancements in understanding ALS mechanisms, therapeutic options remain constrained by disease complexity and heterogeneity.” He continued, “NeuroSense’s PrimeC exhibited promise in Phase 2b, and our analytical synergy, leveraging causal-ML and real-world data, underscores its clinical potential. Our prognostic analysis foresees PrimeC’s success across diverse subgroups in the Phase 3 trial.“
PhaseV’s proprietary technology offers a strategic advantage in drug development, facilitating subgroup and endpoint identification crucial for Phase 3 trial success. By empowering companies to anticipate drug candidate performance and optimize trial designs, PhaseV contributes to achieving impactful and efficacious outcomes.
Conclusion:
NeuroSense’s collaboration with PhaseV signals a strategic move towards enhancing ALS treatment efficacy. Positive Phase 2b trial results and PhaseV’s predictive analysis underscore PrimeC’s potential market differentiation. This partnership sets a precedent for leveraging advanced analytics to refine clinical trial strategies, ultimately benefitting both patients and stakeholders in the ALS treatment market.
