RegeneRx to Receive EU Patent for Molecule That May Lead to MS Remyelination Therapy

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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RegeneRx Biopharmaceuticals announced that it has received an Intent to Grant notice from the European Patent Office (EPO) regarding a patent for its proprietary molecule Thymosin beta 4 (Tβ4), a potential therapy for multiple sclerosis (MS) designed to promote remyelination.

The patent will cover the use of Tβ4 in a composition for treating or reducing deterioration that results in injury or damage to tissues caused by MS. It will expire on Jan. 13, 2026.

An injectable formulation known as RGN-352 was developed based on Tβ4, and is designed to be administered systemically to prevent and repair damage that results from central nervous system (CNS) tissue-associated disorders, such as MS, cardiac damage from heart attacks, and traumatic injuries such as stroke. The drug candidate is Phase 2 clinical trial ready, the company said in a press release.

“This patent expands our exclusivity for the potential administration of RGN-352 in patients with multiple sclerosis in key countries in Europe and broadens our patent portfolio related to the systemic use of RGN-352 for CNS and neurodegenerative disorders. We are pleased patent applications for our technologies, some of which were initially filed years ago as part of our intellectual property strategy, continue to be granted throughout the world,” said J.J. Finkelstein, president and chief executive officer of RegeneRx.

As reported by Multiple Sclerosis News Today, a recent article detailed the process by which Tβ4 effectively was seen to promote remyelination in two separate animal models commonly used for MS research. The article, “Thymosin beta4 promotes oligodendrogenesis in the demyelinating central nervous system,” was published in the journal Neurobiology of Disease.

Specifically, researchers showed that Tβ4 is effectively able to promote the proliferation and differentiation of oligodendrocyte progenitor cells (OPCs) into mature, myelin-producing oligodendrocytes, while also decreasing damage to axons (long projections of neurons that transmit information to different neurons and muscles) in both mice models of MS.

Myelin is the lipidic material that protects nerve fibers in the central and peripheral nervous systems. Myelination is the process of myelin formation around neurons, and is carried out by oligodendrocytes in the CNS. Demyelination (the process of myelin destruction) is a typical feature of MS, and there are currently no remyelination therapies in use.

RGN-259, the company’s Tβ4-based ophthalmic drug candidate, is now in clinical testing in patients with neurotrophic keratopathy.

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