Hello Everyone,
I hope that you have been watching our last few profiles. Several of our more recent ones have gone on to make strong short term double digit moves. Our last one in particular was an exciting one to watch trade during the session.
We have another company that is fresh to our following.
We have never come across this ticker before but after taking a Quick Look at it, we all agree that this is a company tha you need to start your research on right away.
Pull up NRSN right away.
NeuroSense Therapeutics is a clinical-stage biopharmaceutical company, focusing on the discovery and development of targeted innovative therapeutics for neurodegenerative diseases.
NeuroSense was founded in 2017 by Alon Ben-Noon, following a chance meeting with Shay Rishoni, an ALS patient.
During this meeting, Alon was inspired by Shay, who served as the CEO of a non-profit organization for ALS. Despite Shay not having a physical voice, therefore communicating via eye movement and computer software, the connection was instant. Shay detailed his activities in the ALS field, and described the efforts that are being made to solve the ALS puzzle, leading Alon to team up with world-renowned scientists and colleagues in order to research and develop an effective drug for ALS patients, bringing about the establishment of NeuroSense.
They just dropped some exciting news this morning that you need to read right away.
NeuroSense Demonstrates Statistically Significant Efficacy and Survival Benefits in People Living with ALS: The Promising Results from the 12-Month PARADIGM Study Highlight PrimeC's Potential as a Disease Modifying Drug
PR Newswire
7 min read
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Disease progression was slowed by 36% (p=0.009) in participants who received PrimeC for 12 months compared to those who initially received a placebo
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Consistent data across multiple endpoints underscore the potential of PrimeC to redefine the ALS treatment paradigm
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NeuroSense planning for Phase 3 clinical study in the U.S. and Europe
CAMBRIDGE, Mass., July 1, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2bstudy evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).
The data show a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo. Specifically, the intent to treat (ITT) analysis of the study at 12 months revealed a difference of 6.5 points in the ALSFRS-R, which represents a 36% improvement and a highly statistically significant P value of 0.009.
In addition, at 12 months participants on PrimeC demonstrated better survival than those initially on placebo, by 43%.
In an additional pre-defined analysis of the Per-Protocol Population at 12 months, the results showed an even greater effect, with a difference of approximately 7.7 points (p=0.003) between the groups, translating to more than 40% improvement for participants who received PrimeC from the start compared to those on placebo. Furthermore, this analysis indicated that the survival rate of participants on PrimeC improved by 63% compared to participants who received a placebo.
"These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development," said Merit Cudkowicz, M.D., M.Sc., chair of neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. "The need for new treatments for people living with ALS has never been greater. PrimeC has great potential based on its mode of action and the phase 2 trial results and warrants further evaluation in a Phase 3 trial in an expeditious manner."
Vivian Drory, MD, Head of the ALS clinic at Tel-Aviv Sourasky Medical Center, added: "The promising results from the 12-month PARADIGM study highlight the significant potential of PrimeC as a disease-modifying drug for ALS. These findings underscore the importance of early intervention, which can lead to more substantial benefits, and provide valuable insights that will inform the design of the Company's Phase 3 study, increasing the likelihood of success."
About ALS
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 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.
About ALSFRS-R
Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator.
About PARADIGM
PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time.
As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.
About PrimeC
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 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 a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.
READ THE FULL REPORT HERE: https://www.insiderfinancial.com/profile/nrsn
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