INmune Bio, in collaboration with Professor Armando Villalta, Ph.D. of University California, Irvine School of Medicine, has shown targeting soluble TNF using a Dominant-Negative TNF biologic significantly decreased muscle damage in a murine mdx model of Duchenne Muscular Dystrophy and showed a statistically significant increase in muscle regeneration. Current clinical approaches to limiting muscle damage and inflammation in DMD patients, such as corticosteroids, can be immunosuppressive and promote metabolic problems, leading to significant long-term side effects including muscle atrophy with chronic use. There are currently no approved drugs that promote muscle regeneration in DMD patients. DMD and other muscle disorders are the focus of a diverse array of drug development efforts to slow disease progression, such as decreasing inflammation and fibrosis, or by restoring/replacing missing dystrophin. Prior pre-clinical attempts using non-selective TNF inhibitors to target TNF as a therapeutic approach for treatment of DMD were limited by some of the same side effects identified in clinical and commercial use of these non-selective TNF inhibitors. The Company has formed a wholly owned subsidiary, DN02, Inc., that will hold rights to DMD-specific intellectual property and know-how. The subsidiary will facilitate partnering and business development activities for DMD without impacting the Company’s CNS programs. In summary, INmune Bio believes the therapeutic benefits of DN-TNF in DMD are unique. The Company has put together a development structure that allows the therapy to reach patients without impacting the Company’s core mission – treatment of Alzheimer’s and other CNS diseases.
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