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NeuroSense Therapeutics | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SEC announcement ·  Jan 9 00:00
Summary by Moomoo AI
NeuroSense Therapeutics Ltd., a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development plans for PrimeC, its lead drug candidate for treating amyotrophic lateral sclerosis (ALS). On January 9, 2024, the company issued a press release summarizing its achievements in 2023, including positive results from the Phase 2b PARADIGM trial, which showed a statistically significant slowing of ALS disease progression. The trial demonstrated a 37.4% difference in the ALS functional rating scale revised (ALSFRS-R) compared to placebo, indicating a potential new approach to treating ALS and other neurodegenerative diseases. The company also highlighted its upcoming catalysts for 2024, such as the expected End of Phase 2 meetings with the FDA and EMA in Q2 2024, and the reporting of biomarker study results as...Show More
NeuroSense Therapeutics Ltd., a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development plans for PrimeC, its lead drug candidate for treating amyotrophic lateral sclerosis (ALS). On January 9, 2024, the company issued a press release summarizing its achievements in 2023, including positive results from the Phase 2b PARADIGM trial, which showed a statistically significant slowing of ALS disease progression. The trial demonstrated a 37.4% difference in the ALS functional rating scale revised (ALSFRS-R) compared to placebo, indicating a potential new approach to treating ALS and other neurodegenerative diseases. The company also highlighted its upcoming catalysts for 2024, such as the expected End of Phase 2 meetings with the FDA and EMA in Q2 2024, and the reporting of biomarker study results as early as Q1 2024. NeuroSense is advancing discussions for strategic partnerships and has confirmed its chemistry, manufacturing, and controls (CMC) development plans with the FDA in anticipation of a Phase 3 pivotal trial. Additionally, the company has begun a Phase 2 study for Alzheimer's Disease and continues to explore business opportunities with biotech VCs and pharmaceutical companies.
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