AC Immune SA今日宣布，其针对早期帕金森病（PD）的抗α-突触核蛋白活性免疫疗法ACI-7104，已获得美国食品药品监督管理局（FDA）授予的快速通道资格。这一认证标志着该疗法在治疗神经退行性疾病领域迈出了重要一步。
与此同时，公司透露，VacSYn试验第一部分中，第100周的完整数据结果预计将在2026年下半年公布。目前，已公布的期中结果显示，ACI-7104展现出良好的安全性及免疫原性，并初步释放出活性信号。这些积极迹象为后续研究奠定了坚实基础。
快速通道资格旨在加速针对严重未满足医疗需求药物的开发与审评。ACI-7104获得此资格，意味着其有望通过更高效的流程，早日惠及帕金森病患者。VacSYn试验的推进，正持续为评估这种创新免疫疗法的潜力提供关键证据。
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