Medsenic Being Granted US Patent for Arscimed for RRMS

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by Patricia Inacio, PhD |

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The U.S. Patent and Trademark Office will grant Medsenic a patent covering the use of Arscimed, its investigational formulation of arsenic trioxide, for the treatment of relapsing-remitting multiple sclerosis (RRMS).

Once issued, the patent will protect Arscimed’s use for this indication until 2037. This will add to the already robust family of U.S. patents protecting Arscimed for additional indications.

“This patent represents a further recognition in the strategic US market of the very original properties of Arscimed,” François Rieger, president and co-founder of Medsenic, said in a press release.

Arsenic trioxide, used in ancient Chinese medicine, has been shown to exert anti-inflammatory and immunosuppressive effects by targeting activated cytotoxic T-cells — immune cells involved in most autoimmune disorders — while leaving the normal components of the immune system unharmed.

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The treatment works by boosting oxidative stress in abnormally active immune cells, triggering their death. Oxidative stress is the imbalance between the production of free radicals (natural byproducts of metabolism) and the cells’ ability to detoxify them, resulting in damage.

The new U.S. patent was based on preclinical studies using mice with experimental autoimmune encephalomyelitis (EAE), the most common animal model of MS.

Results showed that treatment with Arscimed reduced the abnormally active immune cells, which delayed disease onset, eased disease signs and severity, reduced neuroinflammation, and prevented the loss of myelin – the protective coating around nerve cells that is lost in MS.

“The studies, in an established animal model of multiple sclerosis, conducted by Medsenic, demonstrate a clear understanding of the mechanism of action of Arscimed and highlight the biological parameters related to the observed correction of severe autoimmune symptoms in the case of a severe neurological disease, exemplified by the EAE,” Rieger said.

“Our results confirm the relevance of our innovative approach and reinforce the legitimacy of the therapeutic development of our product Arscimed and any new oral formulation of our active pharmaceutical ingredient, arsenic trioxide,” he added.

Several clinical trials are currently underway to assess the safety and effectiveness of Arscimed in patients. A proof-of-concept Phase 2a trial in severe systemic lupus erythematosus showed that Arscimed had minimal toxicity, supporting its potential use for other autoimmune diseases.

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