Phase 3 Trials of Tolebrutinib in MS Forms to Include Digital Measures

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by Patricia Inacio, PhD |

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Sanofi Genzyme has extended its collaboration with Koneksa to bring digital measures into its Phase 3 trials of tolebrutinib, an investigational therapy for relapsing and progressive forms of multiple sclerosis (MS).

Through this joint effort, Koneksa’s digital biomarkers were applied to clinical trials of Parkinson’s disease, another disorder of the central nervous system (CNS, the brain and spinal cord).

“We’re proud that our long-term partnership has enabled Sanofi’s deployment of digital measures across multiple therapeutic areas and modalities,” Chris Benko, Koneksa’s CEO, said in a press release. “This project leverages learnings from our collaboration on Parkinson’s disease into multiple sclerosis,” to help address its need for “new treatment options.”

Tolebrutinib is an oral small selective inhibitor of the Bruton tyrosine kinase (BTK) enzyme, which is important for the activity and survival of antibody-producing B-cells. These immune cells are thought to be a key driver of brain and spinal cord inflammation in MS patients.

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In addition to lowering B-cell activity, the experimental therapy is thought to inhibit the activity of microglia (the immune cells of the brain), which has been linked to MS progression.

Four ongoing, global Phase 3 clinical trials are testing tolebrutinib as an MS treatment, and all are currently enrolling eligible patients at sites across the U.S., much of Europe, parts of Asia and South America, and, for most trials, sites in Canada and Australia as well.

HERCULES (NCT04411641) is evaluating the treatment’s safety and efficacy in adults with nonactive (non-relapsing) secondary progressive MS, while PERSEUS (NCT04458051) is enrolling those with primary progressive MS. GEMINI 1 (NCT04410978) and GEMINI 2 (NCT04410991) are both recruiting adults with relapsing forms of MS, which include relapsing-remitting MS and active secondary progressive MS.

Sanofi launched a website to help patients determine their eligibility for a given trial by filling out an online survey with questions related to their MS diagnosis, prior treatments and treatment duration, additional diseases (comorbidities), use of a wheelchair, and geographical location.

Koneksa’s digital biomarkers will support measures of the treatment’s effects in these trials. The release did not specify which measures or devices might be chosen.

Wearable devices and smartphones apps enable the continuous monitoring and collection of health information — collectively called digital biomarkers — from patients. This provides researchers with a comprehensive view of disease progression and treatment response over time. Data collected in this non-invasive way are also in a real-world context.

Among Koneksa’s digital platform is a wearable device that continuously monitors gait and balance. The device can acquire direct measures such as walking speed and distance, and use the data to derive other measures like balance and lateral variability.

Data is collected in near real-time and can add to clinician-reported outcomes in tests, such as those of timed walking distance.

“Digital endpoints in clinical trials make it possible for researchers to gain insights that were never before within our reach,” said Rob Ellis, PhD, head of data science at Koneksa. “We’re excited for Sanofi to continue incorporating Koneksa’s digital biomarker platform into their CNS research.”

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