NeuroSense CEO Recaps 2022 Achievements & Presents 2023 Catalysts
NeuroSense's believes that 2023 presents many opportunities for growth at NeuroSense as topline results are expected in the second half of the year from its Phase 2b PARADIGM clinical trial in amyotrophic lateral sclerosis (ALS). The PARADIGM protocol is now approved for enrollment in four countries: Israel, Italy, Canada, and Germany. Based on recently announced positive AD biomarker study results, NeuroSense plans to commence a Phase 2 study in Alzheimer’s disease in the first half of 2023. In the coming weeks, NeuroSense expects to announce biomarker study results in Parkinson’s disease as well.
“Reflecting on this past year, NeuroSense’s strong performance in 2022 gives great cause for optimism,” stated Alon Ben-Noon. “I thank our dedicated team, collaborators, shareholders, and the ALS community
Video highlights include the following:
ALS Clinical Program for Lead Drug Candidate PrimeC
• PARADIGM: Phase 2b double-blind, placebo-controlled, multinational clinical trial aims to assess PrimeC’s efficacy, as well as safety & tolerability, in people living with ALS.
o Over 50% of the 69 patients have been enrolled, and additional clinical sites are expected to open in the coming weeks.
o Enrollment is expected to be completed in H1 2023.
o Topline results are expected in H2 2023.
• Both a single-dose and a multi-dose Phase 1 open-label, randomized, three-treatment, three-period crossover pharmacokinetic (PK) study were carried out in the US under an FDA-cleared IND protocol.
• Results suggest that the PK profile of PrimeC supports the formulation’s extended release properties, as the active components are released simultaneously.
Pipeline
• Novel biomarkers found in Alzheimer’s disease patients were identified in the Company's studies carried out in 2022, with final results announced in January 2023. These biomarkers could potentially be modulated by the Company’s combination therapy platform.
• The Company intends to conduct a Phase 2 double-blind proof-of-concept study to assess the therapeutic potential of its platform combination drug therapy in AD. This study is expected to commence in the first half of 2023, under the current 2023 budget.
• A Parkinson’s disease biomarker study is ongoing with results expected in the next few weeks.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
“Reflecting on this past year, NeuroSense’s strong performance in 2022 gives great cause for optimism,” stated Alon Ben-Noon. “I thank our dedicated team, collaborators, shareholders, and the ALS community
Video highlights include the following:
ALS Clinical Program for Lead Drug Candidate PrimeC
• PARADIGM: Phase 2b double-blind, placebo-controlled, multinational clinical trial aims to assess PrimeC’s efficacy, as well as safety & tolerability, in people living with ALS.
o Over 50% of the 69 patients have been enrolled, and additional clinical sites are expected to open in the coming weeks.
o Enrollment is expected to be completed in H1 2023.
o Topline results are expected in H2 2023.
• Both a single-dose and a multi-dose Phase 1 open-label, randomized, three-treatment, three-period crossover pharmacokinetic (PK) study were carried out in the US under an FDA-cleared IND protocol.
• Results suggest that the PK profile of PrimeC supports the formulation’s extended release properties, as the active components are released simultaneously.
Pipeline
• Novel biomarkers found in Alzheimer’s disease patients were identified in the Company's studies carried out in 2022, with final results announced in January 2023. These biomarkers could potentially be modulated by the Company’s combination therapy platform.
• The Company intends to conduct a Phase 2 double-blind proof-of-concept study to assess the therapeutic potential of its platform combination drug therapy in AD. This study is expected to commence in the first half of 2023, under the current 2023 budget.
• A Parkinson’s disease biomarker study is ongoing with results expected in the next few weeks.
About NeuroSense
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
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