NeuroSense Collaborates With Lonza to Identify Exosome-Based Biomarkers to Advance Neurodegenerative Disease Treatments & Diagnostics

Lonza and NeuroSense Therapeutics Ltd. recently 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, state-of-the-art 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.

Davide Zocco, Head of Exosomes Development, Lonza, said “Lonza has made significant investments in the exosome field over the past decade, including theacquisition of Exosomics, reflecting our commitment to enable innovators to advance their therapies. Our “Dev-on-Demand” solution provides NeuroSense with access to expert scientists working in state-of-the-art laboratories for their development activities. The team and platform make Lonza the partner of choice for NeuroSense to identify exosomes-based biomarkers.”

Alon Ben-Noon, NeuroSense’s CEO, added “We believe this collaboration could be a game-changer for the ALS and neurodegeneration field, as findings in such biomarkers may advance early diagnosis and treatment, as well as expedite the regulatory pathway for new treatments for the millions of people who suffer from neurodegenerative diseases. Collaborating with Lonza enables us to tap into some of the world’s top experts in exosomes-based therapies research to develop another important measure of PrimeC’s efficacy.”

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 US alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the US 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 key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (RNA) regulation to potentially inhibit the progression of ALS. NeuroSense completed the six-month double-blind portion of its Phase 2b ALS clinical trial which met its safety and tolerability endpoints, as well as showing a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population. Additional data from the Phase 2b trial are expected H1 2024. PrimeC was granted Orphan Drug Designation by the US FDA and the European Medicines Agency (EMA).

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.