MetP® Pharma AG today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent entitled “Treatment of Demyelinating Diseases” (U.S. Appl. No. 16/506,830).
Valid until 2039, the patent addresses a method to treat demyelinating diseases such as multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS) as well as other diseases in which neuroinflammation is a central pathological process. The patent is based on the discovery of an unexpected positive synergism by combined treatment with a steroid hormone (e.g. testosterone) together with a Hedgehog signaling pathway modulator that can promote neural repair by significantly driving remyelination.
This discovery paves the way for a new regenerative medicine approach which has the potential of repairing already damaged myelin whereas current therapeutic strategies are based on immunomodulatory or anti-inﬂammatory approaches aimed at reducing the occurrence of new demyelinating lesions and lacking an efficient regenerative potential.
The patent broadly covers demyelinating and inflammatory diseases of the central nervous system (CNS) such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Devic's disease and Alzheimer’s disease; and demyelinating diseases of the peripheral nervous system such as Guillain-Barré syndrome, chronic inflammatory demyelinating polyneuropathy and Anti-MAG peripheral neuropathy.
The steroid hormone and the Hedgehog modulator can be administered in separate compositions (substantially simultaneously or sequentially) or they can be administered in the same composition. The patent covers any route of administration, favoring intranasal administration.
The market potential for demyelinating diseases is considerable. Among the numerous demyelination diseases, multiple sclerosis (MS) is the most widespread disabling neurological condition of young adults around the world. The Multiple Sclerosis Foundation estimates that more than 400,000 people in the United States and about 2.5 million people around the world have MS. It is an expensive disease to treat, and the direct and indirect health care costs range from US$8,528 to US$54,244 per patient per year in the United States.
Dr. Claudia Mattern, Chief Scientific Officer at MetP Pharma comments: “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.”