NeuroSense Therapeutics

NeuroSense to Present Promising Phase 2b Data for Novel ALS Drug PrimeC at AAN Meeting

2 months ago

• 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.

Annexon's 2025 Outlook: Key Milestones for Neuroinflammatory Disease Therapies

4 months ago

• Annexon anticipates a Biologics License Application (BLA) submission for ANX005 in the first half of 2025, potentially transforming Guillain-Barré Syndrome (GBS) treatment. • Enrollment in the Phase 3 ARCHER II trial for ANX007 in geographic atrophy (GA) is expected to be completed in the latter half of 2025. • Clinical proof-of-concept data for ANX1502, an oral C1s inhibitor targeting autoimmune conditions, is anticipated in the first quarter of 2025. • Annexon's current cash reserves are projected to sustain operations into the second half of 2026, supporting the achievement of critical developmental milestones.

NeuroSense Therapeutics Regains Nasdaq Compliance Amidst PrimeC Development for ALS

5 months ago

• 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 Advances PrimeC for ALS with Global Pharma Partnership and FDA Guidance

5 months ago

• 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 Presents PrimeC Data at ALS/MND Symposium

6 months ago

• 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.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

6 months ago

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.

NeuroSense Therapeutics to Discuss Phase 3 Trial of PrimeC for ALS with FDA

7 months ago

• 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 to Advance Phase 3 ALS Trial Following FDA Meeting

7 months ago

• 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.

NeuroSense Advances ALS Program with FDA Meeting for PrimeC Phase 3 Trial

7 months ago

• NeuroSense has scheduled a Type C meeting with the FDA on November 6, 2024, to finalize the Phase 3 trial design for PrimeC, a potential ALS treatment. • The meeting will focus on ensuring the trial design aligns with FDA requirements for a future 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.

PrimeC Shows Significant Improvement in Key miRNAs for ALS Patients in PARADIGM Trial

7 months ago

• NeuroSense Therapeutics' PrimeC demonstrated significant regulation of key microRNAs (miRNAs) in ALS patients, offering a potential disease-modifying treatment. • The PARADIGM trial revealed that PrimeC enhances miRNA maturation by influencing Dicer, potentially restoring balance to dysregulated miRNAs in ALS. • Patients treated with PrimeC showed consistent effects in miRNA manifestation, a clear distinction from the placebo group, suggesting PrimeC's therapeutic potential. • PrimeC's ability to regulate miRNAs underscores its capability to influence ALS at the regulatory level, where previous treatments have struggled.

NeuroSense's PrimeC Demonstrates Efficacy in ALS, Pursues Early Approval in Canada

8 months ago

• NeuroSense Therapeutics' PrimeC showed a 36% reduction in ALS disease progression and a 43% improvement in survival rates in clinical trials. • The company is pursuing early commercialization approval in Canada based on Phase 2b trial results and Health Canada's Notice of Compliance with Conditions policy. • PrimeC, a novel formulation of ciprofloxacin and celecoxib, has received a key U.S. patent extending its protection to 2042. • Two abstracts featuring PrimeC data will be presented at the 2024 Annual NEALS Consortium Meeting, highlighting clinical outcomes and biomarker analysis.

NeuroSense Therapeutics Regains Compliance with NASDAQ, Plans Phase 3 Trial for PrimeC

8 months ago

• NeuroSense Therapeutics has regained compliance with Nasdaq's minimum bid price requirement, ensuring continued listing on the exchange. • This milestone follows positive Phase 2b trial results for PrimeC, a treatment for neurodegenerative diseases. • The company is now focused on initiating a Phase 3 trial of PrimeC in the United States. • NeuroSense is also in discussions with potential partners to further the development and commercialization of PrimeC.

NeuroSense's PrimeC Shows Promise in ALS with Positive Biomarker and Clinical Data

a year ago

• NeuroSense Therapeutics' PrimeC demonstrated a significant decrease in ferritin levels and increase in transferrin levels, indicating improved iron regulation in ALS patients. • The PARADIGM Phase 2b trial showed PrimeC slowed disease progression by 36% and improved survival rates by 43% compared to placebo over 12 months. • PrimeC-treated patients exhibited a 57% to 73% improvement in complication-free survival compared to placebo, highlighting its potential as a disease-modifying therapy. • NeuroSense plans to submit the 12-month data to the FDA to discuss the regulatory path forward for PrimeC in treating Amyotrophic Lateral Sclerosis.

NeuroSense Therapeutics Regains NASDAQ Compliance After Positive PrimeC Trial Data

a year ago

• NeuroSense Therapeutics has regained compliance with the NASDAQ minimum bid price rule, ensuring continued listing. • The compliance follows positive top-line results from the Phase 2b PARADIGM trial of PrimeC. • NeuroSense is preparing to report results from its collaboration with Biogen, assessing PrimeC's impact on neurofilament levels. • The company is focused on advancing PrimeC as a treatment for neurodegenerative diseases like ALS, Alzheimer's, and Parkinson's.