PrimeC Trial Findings to Aid in Identifying Facial Biomarkers of ALS

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by Mary Chapman |

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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 using artificial intelligence and machine learning approaches. Occulometics use facial and eye movements as indicators of neurological health.

As part of the agreement, NeuraLight will have access to patient data from the recently launched Phase 2b PARADIGM trial (NCT05357950), which is investigating an extended-release formulation of NeuroSense’s PrimeC in up to 69 ALS patients.

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“There is compelling value in the use of precise biomarkers to diagnose and track the progression of neurodegenerative diseases,” Alon Ben-Noon, CEO of NeuroSense, said in a company press release.

“We are very pleased to work with the stellar team at NeuraLight who are pioneering the development of digital oculometric biomarkers, which complement our extensive evaluation of biological markers of ALS,” Ben-Noon added.

Biomarkers to help advance PrimeC as ALS treatment

NeuraLight will use PARADIGM data to spot correlations between occulometric markers and clinical measures of disease activity, including those determined with the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS), a standard measure used to track disease progression.

Biomarkers identified through this process are intended to help in identifying patients more likely to benefit from the potential therapy, increasing the chances that a Phase 3 trial of PrimeC is successful and supports possible therapy approval.

These biomarkers may also play a role in early diagnoses and better monitoring of ALS and neurodegenerative conditions such as Parkinson’s and Alzheimer’s.

“This is a first step in what we envision as a long-term collaboration with NeuraLight in ALS as well as future studies we plan for Alzheimer’s disease and Parkinson’s disease,” Ben-Noon said.

PrimeC is a fixed-dose combination of celecoxib and ciprofloxacin. The two medications are approved for conditions other than ALS. Ciprofloxacin, an antibiotic, is used to treat bacterial infections, and celecoxib is an anti-inflammatory used to relieve pain and inflammation.

Combined, the medications are expected to help slow ALS progression by blocking mechanisms involved in nerve cell death.

Findings in a Phase 2a trial (NCT04165850) of oral PrimeC given three times daily to 15 ALS patients for one year indicated a potential for the investigative medication to slow disease progression.

The PARADIGM trial is investigating an upgraded formulation of PrimeC, taken as twice-daily tablets for six months, against a placebo. Patients may continue using their standard-of-care ALS treatments. The trial is recruiting adults, ages 18–75, at a single site in Israel, with additional locations anticipated in the U.S. and Italy.

Results from the final and third phase of a biomarker study reported that PrimeC led to marked decline in some ALS biomarkers when given as an add-on to standard treatment.

“Along with advancing a promising therapy for ALS, we look forward to demonstrating that oculometrics serve as a robust proxy for the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) through this partnership,” said Rivka Kreitman, PhD, NeuraLight’s chief innovation officer.

“The validation of our technology’s efficacy will improve success rates of trials moving forward — ensuring objectivity, reliability, and replicability, as well as reducing costs and friction,” Kreitman added.