MediciNova granted European patent for potential scleroderma treatment

The patent for MN-001 is based on positive results from a SSc animal model study

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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The European Patent Office has decided to grant MediciNova a patent covering the use of an investigational small molecule called MN-001 (tipelukast) for the treatment of scleroderma.

Once issued, the patent is expected to expire no earlier than June 2035. This means that the company will hold exclusive rights to this specific indication of the small molecule within Europe until at least that date.

“We are very pleased to receive notice of this new patent which covers Europe, and we believe it could increase the potential value of MN-001,” Kazuko Matsuda, MD, PhD, chief medical officer of MediciNova, said in a press release.

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Better support and information needed for range of SSc patients

In scleroderma, or systemic sclerosis, immune cells go awry and trigger other cells to produce too much collagen, a fibrous protein, which builds up in the skin and other tissues, causing them to become inflamed and thicker than normal.

In systemic scleroderma, not only the skin, but also internal organs such as the heart, the kidney, and the lungs, are likely affected by scarring (fibrosis), causing more widespread symptoms.

An oral small molecule, MN-001 has been found to counteract inflammation and fibrosis in preclinical models. The potential scleroderma treatment is thought to achieve its effects through various mechanisms.

For example, it opposes the action of leukotrienes, a type of molecule that plays a role in inflammation. It also inhibits enzymes called phosphodiesterase, blocks another enzyme known as 5-lipoxygenase, and reduces the activity of certain genes, all thought to play a role in the development of fibrosis.

“This new patent is based on positive results from a systemic sclerosis animal model study conducted recently. The Canadian Intellectual Property Office granted a similar patent earlier this year,” Matsuda said.

Canadian patent also covers MN-002

The patent granted in Canada also covered the use of MN-002, a major metabolite of MN-001. A metabolite is a molecule produced by the body when it breaks down another molecule, in this case, MN-001.

Both patents detail the ways in which MN-001 can be taken by the mouth (as tablets, capsules, or a liquid formulation) and its range of doses and dosing frequencies, or how often it can be taken.

More than 600 people have taken MN-001 in clinical trials of other indications, including idiopathic pulmonary fibrosis, and it was considered generally safe and well tolerated.