On November 30, 2021 Neuramedy reported that NM-101 (tomaralimab), a monoclonal antibody against TLR-2 Alpha-synucleinopathies are neurodegenerative diseases caused by the abnormal accumulation of misfolded alpha-synuclein in neurons and glial cells (Press release, Neuramedy, NOV 30, 2021, View Source [SID1234632172]). There are three major types of alpha-synucleinopathies: Parkinson’s disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA).

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Misfolded alpha-synucleins can promote neuroinflammation and neuronal loss and also spread to the neighboring neurons, which are mediated by Toll-like Receptor-2 (TLR-2). Furthermore, TLR-2 is found to be up-regulated in alpha-synucleinopathies.

Therefore, the inhibition of TLR-2 would be one of the promising therapeutic strategies to slow down or halt the progression of alpha-synucleinopathies, along with the therapies targeting alpha-synuclein.

Neuramedy, headquartered in Seoul, is a biotech company focusing on novel therapeutic approaches to treat alpha-synucleinopathies, based on the findings above.

Neuramedy’s NM-101 (tomaralimab) is a first-in-class humanized IgG4 monoclonal antibody against TLR-2 which was originally developed and termed ‘OPN-305’ by Opsona Therapeutics (Dublin, Ireland) for the treatment of myelodysplastic syndrome in 2015. Neuramedy took over the patent and global rights for tomaralimab from Opsona in 2019 and is now applying it to PD.

The company is expanding the potential application of tomaralimab to the treatment of Alzheimer’s disease (AD) in conjunction with Amyloid Solution (Seongnam, South Korea) under the name of ‘AS-M801’, considering that TLR-2 is also up-regulated in beta-amyloidopathy like AD and activated by beta-amyloid as in PD and by alpha-synuclein.

Neuramedy is also developing its novel BBB-penetrating antibody (NM-301) for the treatment of neurodegenerative diseases, in collaboration with Aptamer Sciences, a front-runner in Aptamer Technology that will provide antibodies with a BBB shuttle.

In parallel with these, the company is additionally developing its innovative small molecules (NM-401, NM-402, and NM-403) that can inhibit the aggregation of alpha-synucleins for the treatment of various alpha-synucleinopathies (PD, MSA, and DLB), conjointly with Yungjin Pharm.

Neuramedy is planning to initiate its phase 1b/2a clinical trials of NM-101 for the treatment of AD in the U.S. next year.