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CAMBRIDGE, Mass. – NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a biotech firm engaged in developing treatments for neurodegenerative diseases, has disclosed positive outcomes from its 12-month Phase 2b PARADIGM study of PrimeC for ALS patients. The study showed a 57% improvement in complication-free survival for the Intent to Treat population and a 73% for the Per Protocol population, compared to placebo.
These results build upon earlier findings where PrimeC significantly decelerated disease progression by 36% and enhanced survival rates by 43% versus placebo. Additional benefits were observed in the Per-Protocol analysis, including a 40% improvement in ALSFRS-R scores and a 63% increase in survival rates.
The company plans to submit these 12-month results to the FDA to discuss the next steps for PrimeC. The CEO of NeuroSense, Alon Ben-Noon, expressed confidence in the potential of PrimeC in the market and is looking forward to engaging with the FDA and potential partners.
The PARADIGM trial involved 68 participants across Canada, Italy, and Israel. It also reported a consistent improvement in Slow Vital Capacity, a measure of respiratory function, and a significant reduction in the rate of decline in physical abilities as measured by the ALS Functional Rating Scale-Revised.
PrimeC, an oral formulation combining ciprofloxacin and celecoxib, is designed to target key mechanisms of ALS pathogenesis. It has been granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.
ALS, or amyotrophic lateral sclerosis, is a fatal neurodegenerative disease with a high disease burden and limited therapeutic options. PrimeC's potential to modify the disease course offers hope for patients and clinicians seeking effective new therapies.
This article is based on a press release statement from NeuroSense Therapeutics. The company continues its research and development efforts, focusing on combined therapies for neurodegenerative diseases, with the aim of addressing the significant unmet medical needs in this area.
In other recent news, NeuroSense Therapeutics Ltd. has reported significant findings from its Phase 2b PARADIGM study of PrimeC for treating Amyotrophic Lateral Sclerosis (ALS). The data analysis revealed a 36% reduction in disease progression rate among those treated with PrimeC, with a 43% improvement in survival rates at 12 months.
The company has also secured a securities purchase agreement with a healthcare-focused institutional investor, expecting gross proceeds of approximately $4.5 million. In collaboration with Lonza Group Ltd, NeuroSense is aiming to enhance the understanding and treatment of neurodegenerative diseases.
The financial report for the year ending December 31, 2023, 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. These recent developments are part of NeuroSense's ongoing efforts to develop treatments for ALS and other neurodegenerative diseases.
InvestingPro Insights
As NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) reports promising results from its Phase 2b PARADIGM study, investors may be closely monitoring the company's financial health and market performance.
According to InvestingPro data, NeuroSense has a market capitalization of approximately $20.74 million USD, reflecting its standing in the biotech industry. The company's stock price has experienced a substantial increase over the last six months, with a 39.21% price total return, indicating a growing investor confidence following recent developments.
On the financial side, the InvestingPro Tips highlight some challenges, noting that NeuroSense is quickly burning through cash and has not been profitable over the last twelve months.
Moreover, the company faces weak gross profit margins and its short-term obligations exceed its liquid assets. These factors could be crucial for potential investors to consider when evaluating the company's long-term viability, especially as it progresses towards FDA discussions for PrimeC.
Despite these financial challenges, the clinical success of PrimeC could be a pivotal factor for NeuroSense's future. The company's dedication to addressing the unmet medical needs in neurodegenerative diseases is underscored by its continued research and development efforts.
For those interested in a deeper dive into the financial metrics and additional insights, InvestingPro offers more tips on NeuroSense, which could be accessed with the promo code PRONEWS24 for up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. With 7 additional InvestingPro Tips available, investors can gain a more comprehensive understanding of the company's financial landscape and prospects.
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