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Publication Number
US-11229635-B2
Publication Date
2022-01-25
Expiration Date
Abstract
The present disclosure is directed to method of treatment for treating or ameliorating various conditions pertaining such as bone marrow recovery (or blood cell production), fibrosis, inflammatory diseases, inhibition of cancer cell growth, propagation or malignancy, thrombocytopenia, wound healing, and conditions related to stem cells by the administration of BCN057, 512, or an analog thereof.
Core Innovation
The disclosure describes therapeutics based on BCN057 (YEL002) and BCN512, including BCN512 analogs, for treating and/or preventing fibrosis. Fibrosis is described as excessive extracellular-matrix deposition that occurs after repair and includes radiation-induced fibrosis, and the disclosure focuses on managing fibrosis in a subject by administering BCN512 or analogs as therapeutically effective agents.
A central emphasis is radiation- and other causes of fibrosis, including fibrotic disorders affecting multiple organs. The disclosure lists idiopathic pulmonary fibrosis, acute respiratory distress syndrome, cystic fibrosis, non-cystic fibrosis bronchiectasis, liver fibrosis associated with chronic viral hepatitis B and chronic viral hepatitis C, myelofibrosis, nephrogenic systemic fibrosis, Crohn’s disease, keloid conditions, scleroderma/systemic sclerosis, arthofibrosis, Peyronie’s disease, Dupuytren’s contracture, oral submucous fibrosis, adhesive capsulitis, and related skin fibrosis indications, and states that the fibrosis is not induced by ionizing radiation.
The disclosure ties BCN512 to biological rationale involving Wnt/β-catenin signaling and additional cellular and cytokine-related effects described in the disclosure. It also describes outcomes associated with reduced lung damage and fibrosis, restoration of cytokines, modulation of macrophages, and organoid growth after radiation, and provides compound identity using described structures and formula sets, including Formula IA for BCN057 and Formula IIA for BCN512, along with additional formula/scaffold families for BCN512 analogs.
Claims Coverage
The independent claims are two: a method using BCN512 and a method using an analog of BCN512. Across both independent claims, there is at least one core inventive constraint in common: administering a therapeutically effective amount to treat fibrosis in a subject, with the fibrosis not induced by ionizing radiation. The claim set includes dependent claims that enumerate specific fibrosis types and skin-fibrosis etiologies.
Treating fibrosis with BCN512 for non-ionizing-radiation etiologies
A method of treating fibrosis in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of BCN512 according to the following structure, wherein the fibrosis is not induced by ionizing radiation.
Treating fibrosis with BCN512 analogs defined by structural constraints for non-ionizing-radiation etiologies
A method of treating fibrosis in a subject, comprising administering a therapeutically effective amount of an analog of BCN512 to the subject, wherein the analog is selected from the group consisting of the recited structures and variable relationships, and wherein the fibrosis is not induced by ionizing radiation.
Both independent claims define fibrosis treatment using a BCN512-based agent—either BCN512 itself or an analog selected by specified structural-variable relationships—while requiring that the fibrosis is not induced by ionizing radiation. Dependent claims further narrow the treated fibrosis scope by listing multiple specific fibrotic diseases and, separately, enumerating skin-fibrosis causes and insults.
Stated Advantages
Treating fibrosis in a subject where the fibrosis is not induced by ionizing radiation.
Covering a broad range of fibrotic disorders across multiple organ systems, including skin fibrosis and many enumerated skin etiologies.
Reduced lung damage and fibrosis.
Restoration of cytokines.
Modulation of macrophages.
Organoid growth after radiation.
Documented Applications
Treating/preventing fibrotic disorders described as including idiopathic pulmonary fibrosis, acute respiratory distress syndrome, cystic fibrosis, non-cystic fibrosis bronchiectasis, liver fibrosis from chronic viral hepatitis B and chronic viral hepatitis C, myelofibrosis, nephrogenic systemic fibrosis, Crohn’s disease-associated fibrosis, keloid conditions, scleroderma/systemic sclerosis, arthofibrosis, Peyronie’s disease, Dupuytren’s contracture, oral submucous fibrosis, and adhesive capsulitis.
Treatment of fibrosis described for skin fibrosis resulting from specified causes and insults, including psoriasis, eczema, dermatitis, scleroderma, ulcers/erosions, trauma/burns, bullous disorders, ischemia, ichthyoses, epidermolysis bullosae, hypertrophic scars/keloids, intrinsic aging-related cutaneous changes, photoaging, frictional blistering from mechanical shearing, cutaneous atrophy related to topical corticosteroids, and inflammation of mucous membranes.
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