NeuroSense Therapeutics Ltd. announced a collaboration to evaluate biological changes occurring in people with neurodegenerative diseases, including ALS. This agreement provides NeuroSense with access to Lonza's unparalleled, extracellular vesicles expertise and capabilities quickly and on an 'on-demand' basis, without further commitments. NeuroSense will leverage its extensive experience in biomarker utilization in neurodegenerative diseases.

Lonza will provide the development, optimization, and qualification of a method measuring biomarkers from NDEs, which will be integrated into the development of NeuroSense's lead product candidate for ALS, PrimeC. NeuroSense recently reported positive topline results from the six-month double-blind portion of its Phase 2b PARADIGM trial, a multinational, randomized, double-blind, placebo-controlled clinical study of PrimeC in people living with ALS. Patients treated with PrimeC had a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population as compared to placebo.

Additional biomarker and efficacy endpoints are expected H1 2024. NDEs are small extracellular vesicles generated by neurons that encapsulate a variety of molecules such as proteins, nucleic acids, and metabolites. Identification and measurement of NDEs and their cargo through easily accessible bodily fluids including plasma can facilitate the discovery of new biomarkers for prognosis and therapy, as these vesicles can pass the blood-brain barrier and noninvasively provide a depiction of the current physiological status of neurons in the brain.

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several patients with ALS.