Neurosense Therapeutics (NRSN) Reports Positive Biomarker Data from ALS Phase 2b Clinical Trial

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces positive 12-month iron biomarker data from its Phase IIb study (PARADIGM), which evaluated the safety and efficacy of PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS). This data provides additional insights that align with the Company's recent announcements of improved survival by 43% and slowed disease progression by 36%.

ALS is a multifactorial disease in which iron and its related proteins play a critical role in its pathophysiology. These new results demonstrate the target engagement of PrimeC in iron regulation, which is linked to disease mitigation and improved survival. Iron metabolism is crucial in ALS pathology, with transferrin and ferritin being significant contributors to the progress of the disease. Iron accumulation in various brain regions of ALS patients has been linked to neuronal damage. Elevated ferritin levels, an indicator of iron storage, are consistently observed in ALS patients and are associated with reduced survival and potential oxidative stress. Conversely, lower levels of transferrin, the primary iron transport protein, contribute to iron dysregulation and disease progression.

The 12-month study results show a significant decrease in ferritin levels and a corresponding increase in transferrin levels, both indicating alleviation of the pathology. Iron levels remained stable over the 12-month dosing period, with a mean difference of 4.536 µmol/L (95% CI [1.143, 7.929], p=0.01) compared to those who started on placebo and transitioned to PrimeC after the initial 6-month double-blind phase.

These positive changes in iron metabolism align with improved clinical outcomes. Patients on PrimeC maintained better functionality and survival rates compared to those on placebo.

"The 12-month results from the PARADIGM Phase IIb study are encouraging, showing slowing of disease progression and improved survival outcomes," said Merit Cudkowicz, M.D., M.Sc., Chair of Neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. "This new analysis highlights PrimeC's ability to regulate the iron panel in people living with ALS, underscoring the drug's target engagement. These findings strongly support the proceeding to phase 3 testing of PrimeC in ALS."

The Company is currently compiling additional data to share with the FDA for discussion to determine the clinical and regulatory path forward. Additionally, the Company is continuing advanced discussions with several potential development partners to explore marketing opportunities following the potential completion and approval of PrimeC for ALS.

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