Friday, September 30, 2022


Biotechnology News Magazine

NeuroSense Therapeutics Extends ALS Biomarker Collaboration with Massachusetts General Hospital

The new collaboration expands upon two successful partnered studies concluded in the recent year

Latest Posts

City of Hope to Accelerate Immunotherapy Research & Treatment Innovation with $15 Mil Gift from Ted Schwartz Family

Ted Schwartz, who is now cancer free, achieved complete remission at City of Hope in 2020 with the center's leading CAR T cell therapy after a 16-year battle with lymphoma, provided the gift to City of Hope to advance treatment options that offer better outcomes and quality of life for people living with cancer.

Neurocrine Biosciences Appoints Dr Ingrid Delaet as Chief Regulatory Officer

Prior to joining Neurocrine Biosciences, Dr Ingrid Delaet served as Senior Vice President, Regulatory Affairs at Intercept Pharmaceuticals, which she joined in 2016.

Astrea Bioseparations Introduces Nereus LentiHERO, a Fit-for-purpose Solution for Lentiviral Vector Purification

“We believe that AstreAdept will be a game-changer,” explained Astrea Bioseparations’ CEO Terry Pizzie. “Our approach was to rapidly develop and incorporate this material into the Nereus LentiHERO, a simple, fit-for-purpose device that radically transforms how lentivirus can be purified [in terms of speed, recovery, and efficiency].

At Pack Expo, Schreiner MediPharm to Debut Functional Labels Designed from More Sustainable Materials

Schreiner MediPharm advises he new label concepts are based on existing items in Schreiner MediPharm’s roster of functional labeling solutions.

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments for neurodegenerative diseases, announced today the initiation of the third stage of a collaborative biomarker study with Massachusetts General Hospital (MGH).

The extension of this collaborative effort follows two prior successful studies conducted with the novel neuron derived exosomes platform, also completed in collaboration with MGH.

The initial study identified ALS biomarkers that are indicative of the mechanism of action for PrimeC, the lead product development candidate in NeuroSense’s pipeline, by analyzing blood samples obtained from healthy people and people living with ALS. The second study analyzed blood samples from patients treated with PrimeC in NeuroSense’s NST002 trial and examined the longitudinal effect of PrimeC administration on those identified biomarkers. The results following 12 months of treatment with PrimeC, showed statistically significant changes in key ALS-related biomarkers such as TDP-43, neuroinflammation and lysosomal trafficking. Moreover, there was a correlation between the clinical meaningful outcomes and changes in those biomarkers.

The new study, building upon the success of the first two studies, is intended to expand the insight into these biomarkers and their correlation to the progression of ALS symptoms by evaluating the same biomarkers longitudinally in patients who have not been treated with PrimeC. This enhanced understanding of the mechanism of action for PrimeC and its impact on disease progression is intended to provide support regarding the effectiveness of PrimeC in treating ALS and assist NeuroSense in optimizing the clinical trials that are planned for FDA approval and commercialization.

MGH conducts the largest hospital-based research program in the world and is the largest teaching hospital of Harvard Medical School, with an annual research budget of more than $1 billion in 2019. It is currently ranked as the #5 best hospital in the United States by U.S. News & World Report.

“NeuroSense’s Phase 2a clinical study showed promising clinical outcomes together with significant changes in ALS-related biomarkers, supporting biological activity of PrimeC in ALS patients. These findings provide valuable insight into the development and discovery of new ALS biomarkers and treatment options, and may expedite PrimeC development while increasing its potential to reach the market. We are excited by these results and look forward to the ongoing fruitful collaboration with MGH,” noted Dr. Shiran Zimri, PhD., Head of the Scientific Program at NeuroSense.

Dr. Ferenc Tracik, MD, NeuroSense’s Chief Medical Officer added: “Biomarkers play an increasingly important role in the understanding of ALS and the mode of action of PrimeC, and therefore this study is another important step in our biomarker strategy. The data generated will provide additional insights and will also shape the design and outcome measures of upcoming clinical trials. We are delighted to be working on this cutting-edge technology in collaboration with MGH and appreciate their enormous contribution on this.”

Latest Posts

Learn More




Our Sister Publication

Medical Device News Magazine