NeuroSense’s amyotrophic lateral sclerosis (ALS) therapy has improved survival in a Phase IIb trial, setting the biotech up to move the drug to a pivotal trial.
In the PARADIGM study (NCT05357950), patients treated with PrimeC, a combination of antibiotic ciprofloxacin and a non-steroidal anti-inflammatory agent celecoxib, saw an estimated median overall survival (OS) of 36.3 months, compared to 21.4 months for patients initially assigned to placebo who later crossed over to active treatment in the open-label extension (OLE). This represents over 14 months of improvement and approximately a 70% increase in median survival.
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A log-rank test comparing survival curves demonstrated statistical significance. Further analysis using a Cox proportional hazards model showed that PrimeC treatment was associated with a 65% reduction in the risk of death compared to placebo.
“The long-term survival data further validate the magnitude and durability of PrimeC’s effect in ALS and reinforce its potential as a disease-modifying therapy,” said Alon Ben-Noon, CEO of NeuroSense. “A 65% reduction in the risk of death and a statistically significant extension in median survival of over 14 months represent a clinically meaningful benefit of notable magnitude in ALS. We believe these findings substantially strengthen the clinical and regulatory foundation as we advance toward late-stage development.”
The randomised, double-blind trial enrolled 68 patients to receive either PrimeC or placebo for six months. Following this, all patients then received the study drug during the OLE.
NeuroSense previously reported positive top-line results from the trial, including statistically significant slowing of disease progression and favourable safety and tolerability. Patients in the PrimeC arm reported a decline in disease progression, including sustained daily function over six months. In the results announced in December 2023, there was a 29% difference in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and 13% difference in Slow Vital Capacity (SVC).
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By GlobalDataWhile the latest data has shown significance, it seems to have underwhelmed investors, with the company’s stock dropping 14.7% from $1.00 at market close on 17 February to $0.853 at market close on 18 February. The share price had initially risen by 5% at market open on 18 February following the announcement.
NeuroSense said that it is engaging with regulatory authorities regarding the advancement of PrimeC into pivotal late-stage development.
There are several other candidates set to enter pivotal trials after showing success in Phase II ALS studies. This includes AL-S Pharma, which is advancing its monoclonal antibody (mAb), AP-101, after the drug met its efficacy and safety endpoints in a mid-stage trial. Spinogenix is also advancing SPG302 after it met its primary endpoint of safety and tolerability in the ALS population, with no treatment-emergent serious adverse events (SAEs) reported over a six-month period of daily dosing.
GlobalData predicts that the ALS market in the eight major markets (8MM: The US, France, Germany, Italy, Spain, UK, Japan and Canada) will grow from $318m in 2019 to $1.28bn in 2029.
GlobalData is the parent company of Clinical Trials Arena.
