其1型糖尿病疗法的诊断医学第3阶段试验通过了安全审查,预计2026年3月将取得结果。 Diamyd Medical’s Phase 3 trial for its Type 1 diabetes therapy passed safety review, with results expected in March 2026.

诊断医学第3阶段对1型糖尿病疗法的试验 Diamyd已经无所顾虑地通过了最后安全审查,允许继续。 Diamyd Medical's Phase 3 trial for its Type 1 diabetes therapy Diamyd® has passed its final safety review with no concerns, allowing it to continue. 该试验涉及美国和八个欧洲国家的基因界定的病人,已登记285人参加,超过70人完成了24个月的完整后续跟踪。 The trial, involving genetically defined patients in the U.S. and eight European countries, has enrolled 285 participants, with over 70 completing the full 24-month follow-up. 预计2026年3月将获得早期疗效读数,这可能有助于加速FDA批准. An early efficacy readout is expected in March 2026, potentially supporting accelerated FDA approval. 该治疗基于重新组合的GAD65蛋白质,旨在保持天然胰岛素生产。 The therapy, based on recombinant GAD65 protein, aims to preserve natural insulin production. 瑞典正在建造一个新的生产设施,以支持生产。 A new manufacturing facility is under construction in Sweden to support production.