Timber Pharmaceuticals, Inc. (NYSE American: TMBR), the stock was up 20.57% to $1.06in the extended-hours session. The Company focuses on the development and commercialization of treatments for rare and orphan dermatologic diseases. Years of clinical experience and well-established CMC and safety profiles have resulted in the Company’s investigational therapies possessing proven mechanisms-of-action.
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January 12, 2021, it was announced that-003, the Timber Pharmaceuticals (TMBR), locally delivered formulation of sitaxsentan for systemic sclerosis treatment, received orphan drug designation from the Food and Drug Administration (FDA).
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Orphan drugs are specially designated to treat, prevent, or diagnose diseases and conditions that affect fewer than 200,000 Americans. Systemic sclerosis is one of the rarest types of autoimmune connective tissue disorders. It causes inflammation and thickening of the skin and other connective tissues due to excess collagen deposition. Those with systemic sclerosis develop abnormalities of the skin, the joints, and the internal organs.
The drug sitaxsentan is a highly selective endothelin (ET-A) receptor antagonist, originally developed as an oral treatment for pulmonary arterial hypertension (PAH). A locally delivered form of sitaxsentan TMB-003, which can reduce collagen and address safety concerns associated with orally administered sitaxsentan, has been developed. TMB-003 is being evaluated by Timber to treat scleroderma and is slated to be submitted to the FDA for approval in 2022 as an Investigational New Drug (IND).
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