Phase III Fail for MedDay’s Multiple Sclerosis Treatment

A drug developed by the French company MedDay Pharmaceuticals has failed to treat progressive forms of multiple sclerosis in a phase III trial.

The 642 patients recruited into the trial received either a placebo or a high dose of pharmaceutical-grade Biotin, also known as vitamin B₇. The patients had various forms of the autoimmune condition multiple sclerosis where disability progresses without the symptom flare-ups found in its most common form.

Over 15 months, the drug failed to reverse or slow the progression of disability. This places the company in a tricky situation, as the drug candidate met the same endpoints in a previous phase III trial, which recruited 154 patients.

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In multiple sclerosis, the immune system attacks ‘sheaths’ that protect nerve cells, causing severe disability. Drugs approved by the FDA to slow progressive forms of the condition include the antibody drug ocrelizumab and oral drugs cladribine and diroximel. However, there are no treatments for progressive forms of the condition that are designed to restore the sheaths once destroyed, and reverse disability.

MedDay’s biotin drug is designed to slow or even reverse the progression of multiple sclerosis via two mechanisms. First, it activates metabolic processes that protect the nerve cell, and second, it activates proteins in the cell that repair the protective sheath.

After this setback, MedDay will now talk to regulators and evaluate the trial data. “I remain confident of the importance of the neurometabolic approach to neurodegenerative diseases with high unmet medical need,” stated Frédéric Sedel, MedDay’s CSO and co-founder.

In addition to multiple sclerosis, MedDay Pharma is testing the same drug in other clinical programs. The company is running a phase II trial of the drug in the rare condition Charcot-Marie-Tooth disease, and a phase I trial in hepatic encephalopathy, where the brain is damaged by toxins from underlying liver disease.

Many companies are aiming to slow the progression of multiple sclerosis, and most are targeting inflammation. One exception to this trend is the Swiss company GeNeuro, which is testing a phase II-stage drug designed to stop the disease by targeting a viral gene hidden in our genomes since ancient times. This gene is believed by some to be abnormally expressed in multiple sclerosis, and thus partly responsible for the disease.


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