Médunik Canada and the Population Council join in a research partnership for a potential new treatment for multiple sclerosis

• If proven safe and effective throughout the remaining stages of research, segesterone acetate (SGA) could be one of the first remyelination therapies approved to treat multiple sclerosis
• The project is supported in part by the National Multiple Sclerosis Society's commercial development program, Fast Forward, LLC

BLAINVILLE, QC and NEW YORK, Sept. 10, 2024 /PRNewswire/ - Médunik Canada, a pharmaceutical company specializing in treatments for rare and debilitating diseases and part of Duchesnay Pharmaceutical Group (DPG), and the Population Council, a leading non-profit research organization dedicated to enhancing the health and well-being of current and future generations, today announced the start of a research partnership to investigate a potential new treatment for multiple sclerosis (MS).

The multi-year collaboration will start with investigative and pre-clinical research to study the possible use of segesterone acetate (SGA), a potent progestin, developed by the Population Council in the early 2000's that later showed potential value as a treatment option for MS.

Multiple sclerosis is a chronic, inflammatory, and demyelinating disease of the central nervous system (CNS), where the immune system attacks and destructs myelin, a substance that protects and insulates nerve fibers. Remyelination, the natural process of replacing damaged myelin, is impaired over time in MS, which makes the enhancement of remyelination an important therapeutic objective¹. Segesterone acetate has been shown to induce remyelination in animal models ^2,3 supporting its clinical development as a treatment option in MS in combination with the current disease modifying therapies.

"Building on our extensive knowledge in debilitating diseases and women's health, we are thrilled to collaborate with the Population Council on this clinical development program to study the potential of SGA as a treatment option for multiple sclerosis," said Rafik Marouf, Director, Medical Affairs, Médunik Canada. "This is the first original product research development program for Médunik Canada, so it is a very important evolution for us. We look forward to conducting the necessary pre-clinical work and, if successful, proceeding to a proof-of-concept clinical trial in humans."

"I am thrilled to hear the great news about these collaborative agreements," said Dr. Regine Sitruk-Ware, Distinguished Scientist from the Population Council. "Segesterone acetate's potential ability to protect and regenerate neurons via neurogenesis, remyelination, and anti-inflammation indicate its potential clinical utility. It is time to confirm the preclinical findings in a first clinical trial in patients with MS."

The research will be overseen by the Population Council together with Médunik Canada providing scientific guidance and comment through a joint Scientific Advisory Committee. The first study will be conducted and overseen by top-class experts in neurological diseases and specifically in the management of patients with multiple sclerosis.

"This project is a natural step forward for DPG, which has been involved in numerous studies on women's health through Duchesnay and now continues to close the gap on women's health needs through Médunik Canada," said Éric Gervais, President, DPG. "Striving to find solutions for the complex challenges in debilitating diseases, Médunik Canada and the Population Council are well positioned to lead this project with potential global impact, changing the lives of millions affected by MS, three-quarters of whom are women".

Along with financing from Médunik Canada, the project is being funded in part by a grant from the U.S. National MS Society through its Fast Forward program which supports the development of new and promising MS treatments.

"The Population Council is excited to enter this original research collaboration with Médunik Canada to investigate a potential new treatment for MS, a serious and unpredictable disease that affects 2.8 million people in the U.S., Canada and around the world," said James Sailer, Executive Director, Center for Biomedical Research, the Population Council. "We are grateful for the funding received from Médunik Canada and the National MS Society which will allow us to conduct this promising work."

The research collaboration is starting immediately, and the first results of the preclinical trial are expected by the end of 2025 or early 2026, followed by clinical trials to test the ability of this product to induce myelin regeneration. If proven safe and effective throughout the remaining stages of research, segesterone acetate (SGA) could be one of the first remyelination therapies approved to treat multiple sclerosis.

ABOUT MULTIPLE SCLEROSIS

Multiple sclerosis is a chronic inflammatory, unpredictable and debilitating disease of the central nervous system. The cause of MS remains unknown. However, evidence suggests that lifestyle, environmental, genetic and biological factors all contribute. The disease attacks myelin, the protective covering of the nerves, necessary for the transmission of nerve impulses through nerve fibres. The clinical expression of the disease is due to the nerve impulse disruption caused by the damage of myelin. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. So far there is no curative treatment for MS. However, symptomatic treatments and disease modifying therapies decrease the inflammation, reduce the frequency and severity of relapses.

Canada has one of the highest rates of MS in the world, with an estimated 90,000 Canadians living with the disease, three-quarters of whom are women. Most people are diagnosed with MS between age 20 and 49 and will be impacted by the unpredictable effects of the disease for the rest of their lives. For more about the disease in Canada, visit https://mscanada.ca/

ABOUT THE NATIONAL MULTIPLE SCLEROSIS SOCIETY

The National MS Society, founded in 1946, is the global leader of a growing movement dedicated to creating a world free of MS. The Society funds cutting-edge research for a cure, drives change through advocacy and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalmssociety.org, Facebook, X (formerly known as Twitter), Instagram, YouTube or 1-800-344-4867.

ABOUT POPULATION COUNCIL

The Population Council is a leading research organization dedicated to building an equitable and sustainable world that enhances the health and well-being of current and future generations. We generate ideas, produce evidence, and design solutions to improve the lives of underserved populations around the world. To learn more about the Council, our innovation hubs, and our international offices: https://popcouncil.org/

ABOUT MÉDUNIK CANADA

Médunik Canada's vision is to improve the health and quality of life of Canadians living with a rare and debilitating disease. Founded in December 2009, and part of Duchesnay Pharmaceutical Group, the company provides access to orphan drugs through strategic global partnerships as well as domestic and international research and development projects. For more information, please visit https://medunikcanada.com/en/

ABOUT DUCHESNAY PHARMACEUTICAL GROUP

Duchesnay Pharmaceutical Group (DPG), with its affiliated companies, is headquartered in Blainville, Quebec. The Group consists of six pharmaceutical companies to meet the needs of patients in Canada, the U.S. and abroad.

DPG is one of the eight companies across the country chosen to participate in the Government of Canada's Global Hypergrowth Project. This appointment offers exclusive and personalized support for at least two years, in order to accelerate its growth to become an anchor firm in the Canadian economy.

DPG, through its proprietary research and development, and through exclusive partnerships, offers innovative treatments for a variety of medical conditions in women's health, urology, oncology and for rare diseases, plus lower-cost generic medications. DPG recognizes the dedication and professionalism of its employees and promotes a positive culture and flexible work environment. It is deeply committed to environmental responsibility and to giving back to the community through the support of various charitable organizations.

For more information, please visit https://duchesnaypharmaceuticalgroup.com/en.

MEDIA CONTACTS:

• Médunik Canada: Mariia Savchuk, Senior Advisor, Communications, [email protected], +1 (263) 388-3141
• Population Council: Joe Shaffner, Director of Communications, [email protected], (202) 237-9401

References:

1. The biology of CNS remyelination: the key to therapeutic advances. Franklin RJ, Kotter MR.J Neurol. 2008 Mar;255 Suppl 1:19-25. doi: 10.1007/s00415-008-1004-6.PMID: 18317673 Review

2. Progesterone and nestorone promote myelin regeneration in chronic demyelinating lesions of corpus callosum and cerebral cortex. El-Etr M, Rame M, Boucher C, Ghoumari AM, Kumar N, Liere P, Pianos A, Schumacher M, Sitruk-Ware R.Glia. 2015 Jan;63(1):104-17. doi: 10.1002/glia.22736. Epub 2014 Aug 4

3. Nestorone^® , a 19nor-progesterone derivative boosts remyelination in an animal model of demyelination. El-Etr M, Akwa Y, Rame M, Schumacher M, Sitruk-Ware R.CNS Neurosci Ther. 2021 Apr;27(4):464-469. doi: 10.1111/cns.13538. Epub 2020 Dec 24

SOURCE Médunik Canada