New collaboration will evaluate segesterone acetate as MS therapy
Progesterone hormone compound expected to promote myelin restoration
The pharmaceutical company Médunik Canada and Population Council, a nonprofit research organization, are teaming up to investigate the potential use of segesterone acetate, a derivative of the hormone progesterone, as a multiple sclerosis (MS) therapy.
The compound is expected to promote the restoration of myelin, the substance that surrounds and protects nerve cells and which is lost in MS.
The multiyear collaboration will begin immediately, according to the new partners, with results from the first preclinical study expected by late 2025 or early 2026. Should the findings be positive, Médunik Canada and the Population Council expect to launch clinical trials in patients soon thereafter, the two said in a joint press release.
“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 of the center for biomedical research at the Population Council.
Some funding for the project was granted by the National Multiple Sclerosis Society, a U.S.-based nonprofit.
Médunik Canada, Population Council team up on possible MS therapy
MS is marked by progressive demyelination, or myelin loss, due to the immune system’s mistaken attacks against myelin components. Consequently, nerve cells become progressively damaged and die off.
The body is normally able to restore myelin that’s been lost or damaged, a process called remyelination, but that ability is impaired in people with MS. Thus, therapeutic strategies to boost remyelination are of significant interest for treating the neurodegenerative disease, with numerous candidates in preclinical and clinical development.
Developed by the Population Council in the early 2000s, segesterone acetate is a potent progestin, a lab-made version of the female sex hormone progesterone. It’s included as a component of certain forms of hormonal contraceptives that are sold in the U.S.
Research over the last few decades has indicated that progesterone is neuroprotective and plays a role in myelin repair. Additional studies suggested that segesterone acetate may have similar benefit, with the ability to promote remyelination and also reduce neuroinflammation in mouse models of MS.
Its developers thus believe it could be a promising option as an MS therapy when combined with existing disease-modifying treatments.
“Segesterone acetate’s potential ability to protect and regenerate neurons via neurogenesis, remyelination, and anti-inflammation indicate its potential clinical utility,” said Regine Sitruk-Ware, MD, a distinguished scientist from the Population Council.
“It is time to confirm the preclinical findings in a first clinical trial in patients with MS,” Sitruk-Ware added.
We look forward to conducting the necessary pre-clinical work [on segesterone acetate] and, if successful, proceeding to a proof-of-concept clinical trial in humans.
At first, however, the new collaboration will focus on gathering additional preclinical evidence of segesterone acetate’s potential as an MS therapy. The Population Council and Médunik Canada will jointly oversee the research and provide scientific guidance through a scientific advisory committee.
The initial planned study will be conducted by top-class experts in neurological diseases and MS management, according to the partners.
“We look forward to conducting the necessary pre-clinical work and, if successful, proceeding to a proof-of-concept clinical trial in humans,” said Rafik Marouf, director of medical affairs at Médunik Canada.
Funding for the project comes from Médunik Canada, a part of Duchesnay Pharmaceutical Group, along with a grant from the National Multiple Sclerosis Society through its Fast Forward program. Fast Forward supports the development of new MS treatments still in the preclinical stages.
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