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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宣布允许Aramchol获得用于治疗肺纤维化和真皮纤维化的新专利
Benzinga ·  2023/09/26 08:43

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.

治疗肝脏、代谢和纤维化疾病的临床阶段生物制药公司Galmed Pharmicals Ltd.(纳斯达克股票代码:GLMD)(“Galmed” 或 “公司”)今天宣布,允许一项与肺纤维化和真皮纤维化治疗相关的日本专利。墨西哥已经批准了一项类似的专利。该专利在美国和世界其他地区尚待批准。凭借这项最新专利,Galmed正在加强其铅化合物Aramchol的专利保护并将其延长至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报告的结果显示,在肺纤维化的临床前模型中,Aramchol具有显著的抗纤维化作用。在经过验证的肺纤维化博来霉素模型(IPF)中,使用Aramchol治疗可使纤维化得到统计学上显著的改善,与金标准治疗的吡非尼酮相当。纤维化严重程度的所有重要指标均有发现,包括羟脯氨酸(纤维化组织中胶原蛋白沉积的标志物)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 Pharmicals首席执行官兼总裁艾伦·巴哈拉夫评论说:“纤维化是慢性炎症的常见并发症,会影响所有器官和组织。迄今为止,只有有限的抗纤维化药物获得批准或正在开发中,其中大多数具有限制性的副作用。这些专利强化了Aramchol Meglumine作为治疗各种未解决的纤维化适应症的潜在治疗方法的价值,而不仅仅是我们最初关注的肝脏和胆管。”

About Idiopathic pulmonary fibrosis (IPF)

关于特发性肺纤维化 (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.

特发性肺纤维化(IPF)是一种病因不明的严重慢性、进展性、纤维化间质性疾病,尽管批准的治疗受到副作用的限制,但其需求仍未得到满足。博来霉素是一种导致人类患者肺纤维化的抗肿瘤药物,已被广泛用于啮齿动物模型以模仿IPF,并作为诱导动物实验性肺纤维化的标准药物。博来霉素重现了人类疾病的典型特征。

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