CAMBRIDGE, Mass. - NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a biotechnology firm focused on neurodegenerative diseases, has announced significant findings from its Phase 2b PARADIGM study of PrimeC for treating Amyotrophic Lateral Sclerosis (ALS). The 12-month data analysis revealed a 36% reduction in disease progression rate among those treated with PrimeC compared to placebo recipients, with a notable P value of 0.009.
The study measured outcomes using the ALS Functional Rating Scale-Revised (ALSFRS-R), a tool for tracking ALS progression. Participants on PrimeC also showed a 43% improvement in survival rates at 12 months. Further analysis of the Per-Protocol Population indicated even greater benefits, with over 40% improvement in disease progression and a 63% increase in survival rates for PrimeC-treated individuals.
Merit Cudkowicz, M.D., M.Sc., of Massachusetts General Hospital, highlighted the study's implications for ALS treatment and the potential for PrimeC, which targets multiple key mechanisms of the disease. Vivian Drory, MD, from the Tel-Aviv Sourasky Medical Center, emphasized the importance of early intervention and the insights for the upcoming Phase 3 study design.
ALS is an incurable condition leading to paralysis and death within 2-5 years of diagnosis, with over 5,000 new cases annually in the U.S. alone. The PARADIGM trial included 68 participants across Canada, Italy, and Israel, with a high percentage opting to continue PrimeC treatment after the trial.
PrimeC combines ciprofloxacin and celecoxib in an extended-release oral formulation, with previous Phase 2a trials meeting safety and efficacy endpoints. The drug has received Orphan Drug Designation in the U.S. and EU.
NeuroSense is preparing for a Phase 3 clinical study in the U.S. and Europe, as the company continues to develop treatments for ALS and other neurodegenerative diseases.
The information reported is based on a press release statement from NeuroSense.
In other recent news, NeuroSense secured a securities purchase agreement with a healthcare-focused institutional investor, expecting gross proceeds of approximately $4.5 million. The funds will be allocated towards working capital and general corporate purposes. In addition, NeuroSense announced a collaboration with Lonza Group Ltd, aimed at enhancing the understanding and treatment of neurodegenerative diseases.
The company also disclosed significant clinical outcomes from its Phase 2b PARADIGM ALS trial and revealed financial results for the year ending December 31, 2023. The financial report showed an 18% increase in research and development expenses and a 20% decrease in general and administrative expenses.
NeuroSense ended the year with approximately $2.6 million in cash.
InvestingPro Insights
Amidst the promising clinical outcomes for NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) in their fight against ALS, a look at the company's financial health through InvestingPro data provides a broader picture of its market position. NeuroSense, with a market capitalization of $20.2 million, is navigating the biotech landscape with a significant dedication to research and development, as evidenced by its latest findings in the PARADIGM study. The InvestingPro data shows a notable 32.5% return in stock price over the last week, indicating investor optimism following the recent announcement.
The company operates with a moderate level of debt and does not pay dividends, which is typical for a biotech company focused on growth and reinvestment into research. Nevertheless, NeuroSense's financials reflect the challenges of a development-stage biotech firm, with an adjusted P/E ratio for the last twelve months as of Q1 2024 sitting at -1.6, demonstrating that the company is not currently profitable. This is further highlighted by an operating income of -$12.05 million, suggesting that NeuroSense is heavily investing in its pipeline and clinical trials.
Investors considering NeuroSense should note the company's volatility, as the InvestingPro Tips indicate significant stock price movements and a large price uptick over the last six months. With additional tips available on InvestingPro, those interested in a deeper dive into NeuroSense's financials can explore further with a special offer: use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are currently 9 additional InvestingPro Tips available for NRSN, which can provide valuable insights into the company's financial trends and investment potential.
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