NeuroSense has reported additional topline data from its Phase IIb trial of PrimeC (celecoxib and ciprofloxacin) to treat amyotrophic lateral sclerosis (ALS), including primary endpoint data.   

In December 2023, the clinical-stage biotech announced that the Phase IIb PARADIGM trial (NCT05357950) had met its primary and secondary endpoints, but the primary endpoint data was not reported.  

PrimeC demonstrated a statistically significant slowing of disease progression compared to the placebo with a 37.4% difference, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated tool to assess the severity of ALS and monitor a patient’s functional performance. This served as the primary endpoint for the study.  

ALS is a progressive, neurodegenerative disease that affects nerve cells in the brain and spinal cord, leading to loss of muscle control and eventually paralysis. PrimeC activates DICER and inhibits COX-2—two enzymes linked to ALS through their involvement in neuroinflammation and miRNA dysregulation, which are common features of the disease. 

Further analysis of PARADIGM is undergoing, with neurofilament results expected in Q1 2024 and TDP-43 and prostaglandinJ2 biomarker data expected in H1 2024. 

The lack of treatment options and available cures for ALS has given rise to an unmet medical need. However, successes have been few and far between. Yesterday, Sanofi and Denali reported that the Phase II HIMALAYA trial investigating its ALS therapy SAR443820/DNL788 missed its primary endpoint. Sanofi acquired the ALS therapy as part of a $1bn deal to license multiple drug candidates from Denali. 

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Still, earlier this month, Immunity Pharma reported positive topline results from the Phase IIa trial evaluating its anti-apoptosis stressin-1 peptide IPL244 to treat ALS, giving the company the go-ahead to progress the candidate to Phase III. 

According to a report on GlobalData’s Pharma Intelligence Center, there were 74,614 total prevalent cases of ALS in men and women over the age of 40, in the eight major pharmaceutical markets (UK, US, France, Spain, Germany, Italy, Japan and Canada) in 2019. This is expected to grow to 80,483 cases at an annual growth rate (AGR) of 0.79% by 2029. 

GlobalData is the parent company of Clinical Trials Arena. 

In the announcement accompanying the data, chief medical officer of NeuroSense Ferenc Tracik said: “PrimeC’s demonstrated positive effect on quality of life and survival, aligned with the already positive clinical outcome measures, in a relatively small Phase IIb clinical trial truly demonstrates its potential to deliver a meaningful benefit.”