开拓药业-B(09939.HK):福瑞他恩针对痤疮适应症的I/II期临床试验首批患者成功入组给药
格隆汇 4 月 16日丨开拓药业-B(09939.HK)发布公告,2021年4月16日,福瑞他恩凝胶针对痤疮适应症的临床试验已于中国完成首批患者招募并成功给药。此次I/II期临床试验为随机、双盲、安慰剂对照的临床研究,旨在评估福瑞他恩治疗轻中度痤疮患者的安全性、耐受性、药代动力学和疗效。
根据披露,痤疮是一种慢性炎症性皮肤病,以开放或闭合的粉刺及炎性病变(如丘疹、脓疱或结节)为特点。痤疮是一种常见疾病,特别是在青少年及年轻人中。痤疮发病机制复杂,雄激素及其受体(AR)信号通路对皮脂腺及皮脂分泌的影响是引起痤疮的重要因素之一。中国目前尚无有效的局部雄激素受体拮抗剂可用于痤疮的治疗,市场未被满足的临床需求很大。
福瑞他恩是靶点明确的外用雄激素受体拮抗剂,其通过竞争性抑制皮肤组织内的雄激素与雄激素受体相结合,能够局部控制雄激素过高所引起受体信号通路的激活而不改变人体内雄激素受体信号通路的活性。通过涂抹给药的作用方式,福瑞他恩凝胶可抑制毛囊皮脂腺中的雄激素受体与雄激素的结合,从而实现痤疮的治疗。于2020年8月,美国食品药品监督管理局批准了同靶点的痤疮治疗新药,是痤疮治疗40年来获批的创新药物,已经验证该作用机制可以很好地治疗痤疮。针对雄激素脱发适应症,福瑞他恩目前正在中国进行II期临床试验。
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