PrimeC

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…

PrimeC, a treatment candidate for amyotrophic lateral sclerosis (ALS), was found to significantly slow disease progression in certain subgroups of patients in the ongoing PARADIGM Phase 2b trial, according to new data announced by its developer NeuroSense Therapeutics. Benefitting most were people at high risk of rapid disease…

NeuroSense Therapeutics’ investigational therapy PrimeC tends to reduce blood levels of neurofilament light chain (NfL), a biomarker of nerve damage, in people with amyotrophic lateral sclerosis (ALS) — especially when given earlier in the course of the disease. That’s according to data from the PARADIGM Phase 2b…

Treatment with NeuroSense Therapeutics’ PrimeC was found to extend patients’ time without complications or death, and to lead to clinically meaningful effects on quality of life, among those with amyotrophic lateral sclerosis (ALS). The new data comes from the PARADIGM Phase 2b study (NCT05357950), a fully enrolled…

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…

NeuroSense Therapeutics’ PrimeC was found to be safe and well tolerated in a Phase 2b trial, and use of the oral therapy for six months led to “meaningful slowing of disease progression” in people with amyotrophic lateral sclerosis (ALS), the company said in a press release announcing top-line…

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 is planning to soon announce top-line safety and efficacy results from its PARADIGM trial, which is testing PrimeC in people with amyotrophic lateral sclerosis (ALS). News of trial findings being expected in December follows the dosing of a final patient in the randomized portion of…

PrimeC, NeuroSense Therapeutics‘ investigational, fixed-dose combination therapy for amyotrophic lateral sclerosis (ALS), significantly boosted the survival of patient-derived motor neurons to levels similar to healthy controls in a lab study. The independent study was led by Justin Ichida, PhD, a professor of stem cell biology and regenerative…

A Phase 2b trial of PrimeC for people with amyotrophic lateral sclerosis (ALS) has completed patient enrollment, according to NeuroSense Therapeutics, the therapy’s developer. Called PARADIGM (NCT05357950), the study enrolled 69 adults diagnosed with ALS, ages 18-75, at sites in Israel, Italy, and Canada. The company…