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Escala Therapeutics, Inc. (formerly Altamira Bio, Inc.)

Escala Therapeutics (Escala) is a development stage company focused on the development and commercialization of therapies in orphan/rare disorders. Escala acquired from New Zealand Pharmaceuticals Ltd (NZP), a license from the National Institutes of Health (NIH) and Cooperative Research and Development Agreements (CRADAs) for the development of oral N-acetyl-D-mannosamine (ManNAc) for the treatment of GNE Myopathy (aka Human Inclusion Body Myopathy, or HIBM), and other disorders. New Zealand Pharmaceuticals Ltd (NZP) manufactures ManNAc and will remain the exclusive global supplier of ManNAc to Escala Therapeutics.  

ManNAc is an intermediary in sialic acid biosynthesis generated by functional GNE protein, known to be involved in GNE Myopathy. Supplementation of ManNAc to the cells with dysfunctional GNE protein bypasses the need for GNE function and enables protein sialylation. ManNAc has been demonstrated in human studies to significantly increase circulating levels of sialic acid and is shown to treat disease in mouse models of both HIBM and kidney diseases. The FDA has provided orphan designation for ManNAc in HIBM. ManNAc is currently under investigation in an open label Phase I/II study for the treatment of the rare muscle-wasting disease Hereditary Inclusion Body Myopathy (HIBM), also known as GNE Myopathy.   An IND and clinical protocol for a Phase I study to investigate ManNAc safety and tolerability in patients with a range of glomerular disorders (primary podocyte disorders) associated with hyposialylation has been approved by the FDA, and the National Institute of Digestive and Kidney Diseases (NIDDK) Institutional Review Board (IRB).   Fortress Biotech currently owns >50% of Escala Therapeutics.

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