Galmed Announces Allowance Of New Patent For Aramchol For The Treatment Of Pulmonary And Dermal Fibrosis
Galmed Announces Allowance Of New Patent For Aramchol For The Treatment Of Pulmonary And Dermal Fibrosis
Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and fibrotic diseases announced today the allowance of a Japanese patent related to treatment of pulmonary and dermal fibrosis. A similar patent was already granted in Mexico. The approval of the patent in the US and the rest of the world is pending. With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until November 2037.
治療肝臟、代謝和纖維化疾病的臨床階段生物製藥公司Galmed製藥有限公司(納斯達克市場代碼：GLMD)(“Galmed”或“公司”)今天宣佈，批准一項與治療肺部和皮膚纖維化有關的日本專利。墨西哥已經授予了一項類似的專利。該專利在美國和世界其他地區的批准正在等待中。憑藉這項最新專利，Galmed正在加強並將其先導化合物Aramchol的專利保護延長至2037年11月。
Previously, Galmed reported results showing significant anti-fibrotic effects of Aramchol in a pre-clinical model of lung fibrosis. Treatment with Aramchol resulted in statistically significant fibrosis improvement in a validated bleomycin model of lung fibrosis (IPF), comparable to Pirfenidone which is the gold standard treatment. Findings were seen across all important indicators for the severity of fibrosis including hydroxyproline (a marker for collagen deposition in the fibrotic tissue) P< 0.05, Ashcroft score P < 0.005, % CPA (Percentage Collagen Proportionate Area of the lung) P < 0.001, and immunohistochemistry (type I collagen and a SMA) P < 0.005 for both staining.
此前，Galmed報告的結果顯示，在肺纖維化的臨床前模型中，Aramchol具有顯著的抗纖維化作用。在經過驗證的博萊黴素肺纖維化(IPF)模型中，Aramchol治療導致了統計上顯著的纖維化改善，與金標準治療藥物吡非尼酮相當。所有反映纖維化嚴重程度的重要指標包括羥脯氨酸(纖維化組織中膠原沉積的標誌物)P
Allen Baharaff, CEO and President of Galmed Pharmaceuticals, commented: "Fibrosis is a common complication of chronic inflammation and can affect all organs and tissues. To date, only limited anti-fibrotic drugs are approved or are in development, most of which have restricting side effects. These patents reinforce the value of Aramchol Meglumine as a potential treatment for a wide range of unaddressed fibrotic indications beyond our initial focus of the liver and bile duct."
Galmed製藥公司首席執行官兼總裁艾倫·巴哈拉夫評論說：“纖維化是慢性炎症的一種常見併發症，可影響所有器官和組織。到目前為止，只有有限的抗纖維化藥物獲得批准或正在開發中，其中大多數具有限制性副作用。這些專利加強了Aramchol葡甲胺作為一種潛在療法的價值，它可以治療我們最初關注的肝臟和膽管以外的一系列未解決的纖維化適應症。”
About Idiopathic pulmonary fibrosis (IPF)
關於特發性肺纖維化(IPF)
Idiopathic pulmonary fibrosis (IPF) is a severe, chronic, progressive, fibrotic interstitial disease of unknown etiology, which remains an unmet need despite approved treatments which are limited by side effects. Bleomycin, an anti-neoplastic agent that causes lung fibrosis in human patients, has been used extensively in rodent models to mimic IPF and serves as the standard agent for induction of experimental pulmonary fibrosis in animals. Bleomycin reproduces typical features of the human disease.
特發性肺纖維化(IPF)是一種嚴重的、慢性的、進行性的、病因不明的間質性疾病，儘管已批准的治療方法受到副作用的限制，但仍未得到滿足。博萊黴素是一種在人類患者中引起肺纖維化的抗腫瘤藥物，已被廣泛用於類比肺纖維化的齧齒動物模型，並作為誘導動物實驗性肺纖維化的標準藥物。博萊黴素再現了人類疾病的典型特徵。