MetP Pharma‘s patent application for a new method to treat demyelinating and neuroinflammatory diseases, including multiple sclerosis (MS), has been approved by the United States Patent and Trademark Office (USPTO).

The patent, titled “Treatment of Demyelinating Diseases” (U.S. Appl. No. 16/506,830), is valid until 2039, and covers the use of a steroid hormone, such as testosterone, in combination with a Hedgehog pathway modulator.

Steroid hormones are a class of hormones defined by a particular molecular structure, and they play a variety of important roles throughout the body. Testosterone, in particular, is best known for its role in male sex development, but it also plays roles in the regular functioning of the brain, and has been proposed as a therapeutic target for demyelinating diseases (those characterized by the loss of myelin, the protective coat of neurons). MS is a demyelinating disease.

The hedgehog pathway (named for the way flies with mutations in these genes look) is a molecular pathway through which cells transmit information to each other. It is best known for its importance in the development of numerous organ systems, including the brain, and also has been implicated to play a role in protecting neurons from demyelination.

Research suggesting that treatment with testosterone, together with a compound that modulates (changes the activity of) the hedgehog pathway, can drive remyelination and promote neural repair is the basis of the new patent.

The patent broadly covers the use of this therapeutic approach in demyelinating and inflammatory diseases of the nervous system, including MS, amyotrophic lateral sclerosis (ALS), Devic’s disease, Alzheimer’s disease, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyneuropathy.

The patent covers any route of administration, favoring nasal spray. It also allows the administration of the two components together, one at a time, or some variation thereof.

According to MetP Pharma, this new therapeutic approach offers a new regenerative strategy with the potential of repairing already damaged myelin, whereas current therapeutic strategies lack an efficient regenerative potential.

“Most medications used to treat MS are generally ineffective in progressive forms that are characterized by a chronic demyelination of axons. This new method can tremendously boost the remyelination of abnormal axons, and therefore may help to treat demyelinating diseases with high-unmet need better such as MS and ALS. We are excited to add this highly relevant method to our portfolio of granted patents,” Claudia Mattern, PhD, chief scientific officer at MetP Pharma, said in a press release.

MetP Pharma noted it is pursuing other patent applications in all major markets worldwide.