Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases

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Lonza and NeuroSense Therapeutics have announced a collaboration focused on evaluating biological markers in neurodegenerative diseases, such as amyotrophic lateral sclerosis (ALS). According to both companies, the joint venture intends to utilize Lonza’s expertise in extracellular vesicles in combination with NeuroSense’s experience in biomarker utilization for neurodegenerative diseases. The overall goal of this partnership is to enhance development of neurodegenerative disease treatments. This deal comes amid NeuroSense revealing positive results from the Phase IIb PARADIGM trial for PrimeC, focused on treating adults living with ALS.

Under terms of the agreement, Lonza will focus on utilizing neuron-derived exosomes (NDEs) for assimilation into the development of PrimeC.¹

"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,” said Alon Ben-Noon, CEO, NeuroSense, in a press release. “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."

In December, NeuroSense announced that it had achieved its primary safety and tolerability endpoints for the PARADIGM trial of PrimeC. According to the company, patients from Canada, Israel, and Italy were dosed with either the treatment or a placebo for six months. At the end of the trial, it was found that PrimeC slowed down progression of the disease, with data showing a 29% difference in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) (p=0.12) and a 13% difference in slow vital capacity (SVC) (p=0.5). Additionally, 96% of those who participated agreed to enroll in a yearlong open label extension, focusing on continued treatment with PrimeC.²

"The release of this portion of the top-line results of the PARADIGM trial marks an exciting milestone for NeuroSense as we take another step toward helping people suffering from this dire disease. We look forward to meeting with the FDA to determine the best path forward and to advancing discussions with strategic partners who share our vision for PrimeC to benefit people living with ALS," stated Ben-Noon, in a press release. "I would like to thank my devoted team and everyone who made this possible, the trial participants, their caregivers and families, as well as the sites' principal investigators and trial coordinators for their tremendous contribution to PARADIGM."

According to the University of Michigan Health, 90% of ALS cases come without a family history with the disease. By 2040, this rate is expected to increase by 70% globally. Currently, there is no cure and life expectancy is anywhere from two to four years.³

"The clinical advancement of a new therapy that helps slow down the progression of ALS, with the potential to preserve quality of life, has the capacity to significantly positively impact people living with ALS and their families,” said Merit Cudkowicz, MD, chair, neurology, Massachusetts General Hospital, director, Healey & AMG Center for ALS, Julieanne Dorn professor of Neurology, Harvard Medical School, member of NeuroSense's Scientific Advisory Board, in the press release. “While the ALSFRS-R and SVC results are Phase 2 data and were not powered for statistical significance, the positive results support moving forward to a Phase 3 pivotal trial.”

References

1. NeuroSense Collaborates with Lonza to Identify Exosome-based Biomarkers, in order to Advance Neurodegenerative Disease Treatments and Diagnostics. PR Newswire. April 9, 2024. Accessed April 9, 2024. https://www.prnewswire.com/news-releases/neurosense-collaborates-with-lonza-to-identify-exosome-based-biomarkers-in-order-to-advance-neurodegenerative-disease-treatments-and-diagnostics-302111745.html

2. NeuroSense's Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints. PR Newswire. December 5, 2023. Accessed April 9, 2024. https://www.prnewswire.com/news-releases/neurosenses-phase-2b-als-trial-achieves-primary-safety-and-tolerability--secondary-clinical-efficacy-endpoints-302005837.html

3. ALS Facts and Figures. University of Michigan Health. Accessed April 9, 2024. https://www.uofmhealth.org/brain-neurological-conditions/als-facts-figures