Neurosense Therapeutics (NRSN) Announces Peer-Reviewed Publication of Phase IIa PrimeC ALS Study in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration
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NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today announced the peer-reviewed release of Phase IIa clinical data in Amyotrophic lateral sclerosis and frontotemporal degeneration in an article titled “Ciprofloxacin/Celecoxib Combination as a Novel Therapeutic Strategy for ALS” written by NeuroSense Scientific Program Director Dr. Shiran Zimri and ALS Program Director Avital Pushett, as well as the leader of amyotrophic lateral sclerosis (ALS) researchers. See the full paper here: LINK
The data in the article are the results of NeuroSense’s Phase IIa study of its lead drug candidate, PrimeC, a unique and proprietary combination of two FDA-approved drugs, ciprofloxacin and celecoxib, in the treatment of ALS.
Key item data includes:
- The study met its primary safety endpoint in a 12-month clinical trial with 15 participants living with ALS.
Efficacy and biomarkers:
- Exploratory efficacy was assessed by ALSFRS-R and FVC, and blood samples were collected before and during the study for biomarker analysis.
- PrimeC showed statistically significant changes in ALS-related biomarkers of serum neuron-derived exosomes (NDEs) such as TDP-43 and LC3, as measured by ExoSORT™, indicating positive biological activity.
- The trial was open-label, comparing generated data to the PROACT database using propensity matching.
- This study confirms the safety and tolerability of PrimeC in ALS.
- Biomarker analyzes suggest early evidence of a biological effect.
“This clinical study is a very important achievement and milestone for the ALS community. It is very encouraging to see that there was both biological activity and clinical signals of a treatment effect,” said Vivian Drory. , MD, director of the Neuromuscular Diseases Unit at Tel Aviv Sourasky Medical Center and principal investigator of the study. “I am grateful to all participants, their families and staff who took part in this study, and proud and excited to participate in the PARADIGM study, which uses an improved formulation of PrimeC.”
Based on the results of this study, NeuroSense initiated PARADIGM, a Phase IIb clinical trial in May 2022. PARADIGM is randomizing 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. The study’s primary endpoints include assessment of ALS biomarkers, assessment of clinical efficacy, improvement in quality of life, and safety and tolerability.
“This study, along with previously published preclinical work, strongly encourages the continued development of Prime C. We need more treatments for ALS, and PrimeC is an exciting candidate,” said Jeremy M. Shefner, MD, PhD. , FAAN, Professor of Neurology, Chief Physician for Clinical Research at the Barrow Neurological Institute and co-author of the article.
Dr. Erez Eitan, co-author of the study and scientific director of NeuroDex, said, “We are proud to be working with the NeuroSense team on the implementation of ExoSORT™, our proprietary method to isolate neuron-derived exosomes from blood samples for identification and measurement. biomarkers. When we discovered that TDP43, a major biomarker for ALS, and LC3, a biomarker for autophagy, can be measured in NDEs and are different in ALS patients, we hoped this would help advance therapeutic development. We are grateful to NeuroSense for giving us the opportunity to test the biomarkers in their clinical trials. NeuroDex advances brain diagnostics with its proprietary cell-specific exosome diagnostic platform, which provides a non-invasive, inexpensive and robust diagnostic tool.
“We thank the trial participants and their families and caregivers for choosing to participate in this study. We would also like to thank all of our valued collaborators for their teamwork and tireless efforts in the field and in this study,” said the head of NeuroSense. Scientific Program, Dr. Shiran Zimri.
“We are very pleased to have our PrimeC Phase IIa findings published in a leading ALS journal, as interest in PrimeC continues to grow in the ALS scientific community. Our clinical research teams and scientists actively present at conferences as we engage in patient advocacy to bring much-needed effective treatment to those suffering from this debilitating disease,” said NeuroSense CEO Alon Ben-Noon.