相关临床试验
6
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2017
已完成
5
83.3%
招募中
1
16.7%
暂无批准数据
- NeuroSense Therapeutics received FDA clearance to initiate the pivotal Phase 3 PARAGON trial for PrimeC, a novel combination therapy for amyotrophic lateral sclerosis treatment. - The global trial will enroll 300 ALS patients in a 2:1 randomization ratio and is powered at over 95% to achieve its primary endpoint. - PrimeC combines ciprofloxacin and celecoxib in an extended-release formulation designed to target multiple ALS disease mechanisms including motor neuron degeneration and inflammation. - The 12-month placebo-controlled trial builds on promising Phase 2b PARADIGM results that demonstrated favorable clinical and biomarker outcomes with good safety profile.
- NeuroSense Therapeutics reported positive initial results from its Phase 2 RoAD trial, showing that PrimeC treatment enhanced neuroplasticity in patient-derived neurons from Alzheimer's disease patients. - The study utilized NeuroKaire's proprietary technology to generate brain cells from patient blood samples, demonstrating improved brain-cell connectivity and health with no treatment-related toxicity. - PrimeC is a novel oral combination of ciprofloxacin and celecoxib designed to target multiple mechanisms underlying neurodegeneration in Alzheimer's disease. - The findings provide early patient-specific insights into PrimeC's potential therapeutic effects and strengthen the mechanistic rationale for the ongoing 12-month randomized controlled trial.
- NeuroSense Therapeutics raised $500,000 through a private placement at $1.50 per share, representing a 40% premium to market price, demonstrating investor confidence in the company's neurodegenerative disease pipeline. - The financing serves as a bridge to upcoming regulatory milestones for PrimeC, the company's lead ALS therapy currently under development following results from the PARADIGM clinical trial. - This marks the company's third premium-priced private financing, aimed at strengthening the balance sheet while minimizing shareholder dilution as NeuroSense prepares for meetings with FDA and Health Canada. - The biotech company focuses on developing combination therapies targeting multiple pathways for neurodegenerative diseases including ALS, Alzheimer's disease, and Parkinson's disease.
- NeuroSense Therapeutics' PrimeC demonstrated a statistically significant 33% reduction in ALS disease progression (p=0.007) and 58% improvement in survival rates in its Phase 2b PARADIGM trial. - The oral combination therapy showed differential expression of over 100 microRNAs, including downregulation of miR-199 and miR-181 associated with neuroinflammation and mortality. - Despite promising clinical results, the company faces financial constraints with only $3.4 million in cash and is pursuing a critical partnership to fund Phase 3 trials beginning in late 2025.
- NeuroSense Therapeutics will showcase new data from PrimeC's Phase 2b trial in ALS at the American Academy of Neurology Meeting on April 8, 2025, featuring presentations on clinical outcomes and microRNA biomarker findings. - PrimeC, a fixed-dose combination of ciprofloxacin and celecoxib, demonstrated safety, efficacy, and target engagement in an 18-month trial, showing marked reduction in ALS progression and significant changes in disease-related biomarkers. - The oral therapy employs a multi-targeted approach addressing several ALS pathways including motor neuron degeneration, inflammation, iron accumulation, and RNA regulation, potentially offering a disease-modifying treatment for the fatal neurodegenerative disease.
- NeuroSense Therapeutics has regained compliance with Nasdaq's minimum equity requirement, ensuring its stock remains listed on the Nasdaq Capital Market. - This milestone follows the company's successful efforts to bolster its financial position through new equity and reduced liabilities, exceeding the $2.5 million threshold. - NeuroSense is advancing its lead drug candidate, PrimeC, towards a Phase 3 study for ALS, building on promising Phase 2b PARADIGM trial results. - The company will be subject to a one-year monitoring period by Nasdaq to ensure continued compliance with equity requirements.
- NeuroSense Therapeutics has entered a binding term sheet with a leading global pharmaceutical company for PrimeC development, securing upfront payment and Phase 3 trial funding. - The FDA provided positive feedback on the design of NeuroSense's Phase 3 study for PrimeC, an oral treatment for amyotrophic lateral sclerosis (ALS). - PrimeC, a combination of ciprofloxacin and celecoxib, demonstrated positive safety and efficacy in Phase 2b, slowing ALS progression beyond standard treatment. - NeuroSense plans to submit the final protocol to the FDA in H1 2025 and commence the Phase 3 study in mid-2025, aiming for early commercialization in Canada.
- NeuroSense Therapeutics will present Phase 2b PARADIGM trial results of PrimeC, a potential ALS treatment, at the International Symposium on ALS/MND. - Prof. Merit Cudkowicz will present the latest clinical outcomes from the PARADIGM trial, offering insights into PrimeC's potential to improve patient outcomes. - Dr. Cristian Lunetta will share an in-depth biomarker analysis from the PARADIGM trial, providing critical insights into PrimeC's mechanism of action. - The NeuroSense management team will attend, highlighting the company's commitment to advancing ALS research and neurodegenerative disease therapies.
- NeuroSense Therapeutics will meet with the FDA to discuss the Phase 3 trial design for PrimeC, an experimental therapy for amyotrophic lateral sclerosis (ALS). - PrimeC, a combination of ciprofloxacin and celecoxib, aims to modulate inflammation, RNA processing, and iron accumulation, all disrupted in ALS. - Phase 2b trial data showed PrimeC slowed disease progression by 36% and improved survival rates by 43% compared to placebo after one year. - NeuroSense is also seeking early marketing approval for PrimeC in Canada, based on the Phase 2b PARADIGM trial results.
- NeuroSense will meet with the FDA to finalize the Phase 3 trial design for PrimeC, a potential treatment for Amyotrophic Lateral Sclerosis (ALS). - The meeting will focus on ensuring the trial design aligns with FDA requirements for a New Drug Application (NDA) submission. - NeuroSense plans to submit its regulatory dossier to Health Canada in Q2 2025, with a decision expected by Q1 2026. - PrimeC has demonstrated statistically significant reductions in disease progression and improved survival rates in clinical trials.
