NeuroSense Therapeutics is collaborating with PhaseV for insights into how to better design the protocol for the planned Phase 3 trial that will test PrimeC for amyotrophic lateral sclerosis (ALS). A specialist in machine learning technology for clinical trials, PhaseV used data from the ongoing Phase 2b…
People with amyotrophic lateral sclerosis (ALS) given PrimeC in the PARADIGM Phase 2b trial — and who did not diverge in major ways from the trial’s rules — experienced a significant slowing in disease progression compared with a placebo, the treatment’s developer, NeuroSense Therapeutics, announced. This finding…
The U.S. Food and Drug Administration (FDA) has signed off on the chemistry, manufacturing, and controls (CMC) clinical development plan for NeuroSense Therapeutics‘ lead candidate for amyotrophic lateral sclerosis (ALS) ahead of a planned Phase 3 study. The Phase 3 trial of PrimeC is due to start…
NeuroSense Therapeutics has received key patents in Europe, Japan, and Israel covering the use of PrimeC, its investigational, fixed-dose combination therapy, in treating neurological diseases such as amyotrophic lateral sclerosis (ALS). These patents are valid through 2038 and join others covering Prime C’s use in the…
NeuroSense Therapeutics has received the go-ahead to begin enrolling patients in the U.S. and Italy for a Phase 2b clinical trial testing PrimeC, the company’s experimental therapy for amyotrophic lateral sclerosis (ALS). The clinical trial, called PARADIGM (NCT05357950), enrolled its first participant in June. The study is…
An extended-release formulation of PrimeC, an investigational combination therapy for amyotrophic lateral sclerosis (ALS), demonstrated a favorable pharmacokinetic profile in healthy adults in a Phase 1 trial, helping with an ongoing Phase 2b study and work into a potential pivotal trial in ALS patients. A pharmacokinetic (PK) study aims…
NeuroSense Therapeutics has joined EverythingALS’s open innovation consortium to accelerate the development of treatments for amyotrophic lateral sclerosis (ALS). NeuroSense will provide financial support for ongoing research projects from the patient-focused nonprofit organization, such as those that seek to identify biological and digital biomarkers to help detect and monitor ALS.
NeuroSense Therapeutics and NeuraLight are collaborating to identify digital biomarkers, particularly those drawn from facial videos, that would help in detecting and monitoring amyotrophic lateral sclerosis (ALS) and other neurological diseases. Called occulometric biomarkers, they are derived from videos of patients’ faces captured on a webcam and analyzed…
NeuroSense Therapeutics’ combination therapy PrimeC led to a significant decline in certain biomarkers of amyotrophic lateral sclerosis (ALS) when used as an add-on to standard of care treatment, a study found. Standard treatment alone, meanwhile, appeared to have no impact on these disease-related biomarkers. The preliminary results come from…
A Phase 2b clinical trial evaluating NeuroSense Therapeutics’ experimental combination therapy PrimeC in people with amyotrophic lateral sclerosis (ALS) has enrolled its first patient. PARADIGM (NCT05357950) is the company’s next step following the completion of a Phase 2a trial (NCT04165850) wherein the therapy effectively slowed disease…
Get regular updates to your inbox.