– Top-line Phase 1 CSU results expected at year end 2024 – SAN CARLOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven diseases, today announced that the first patient with chronic spontaneous urticaria (CSU) has been dosed in a randomized, double-blind, placebo-controlled Phase 1 trial of AK006.

-预计2024年底CSU第一阶段的最高结果-加利福尼亚州圣卡洛斯，2024年5月28日（环球通讯社）-Allakos Inc.（纳斯达克：ALLK），一家开发用于治疗肥大细胞驱动疾病的AK006的生物技术公司，今天宣布，第一名慢性自发性荨麻疹（CSU）患者已在AK006的随机，双盲，安慰剂对照的第一阶段试验中服用药物。

The Phase 1 trial is designed to assess the safety, tolerability and pharmacokinetics of AK006, and to explore the therapeutic effects of AK006 in patients with CSU using the urticaria activity score (UAS7) at 14 weeks. Top-line results from the trial are expected at year end 2024. Chronic Spontaneous Urticaria CSU symptoms are caused by the inappropriate activation of mast cells in the skin.

第一阶段试验旨在评估AK006的安全性，耐受性和药代动力学，并在14周时使用荨麻疹活动评分（UAS7）探讨AK006对CSU患者的治疗效果。预计该试验的最终结果将于2024年底公布。慢性自发性荨麻疹CSU症状是由皮肤中肥大细胞的不适当激活引起的。

IgE-dependent mast cell activation has been identified as a pathogenic driver of CSU, and agents which target this pathway have demonstrated therapeutic activity. More recently, IgE-independent pathways, such activation through the MRGPRX2 receptor, have been implicated in CSU disease pathogenesis. Agents that target both IgE-dependent and IgE-independent modes of mast cell activation have the potential to work in a broader patient population or show greater symptom improvement.

IgE依赖性肥大细胞活化已被确定为CSU的致病驱动因素，靶向该途径的药物已显示出治疗活性。最近，通过MRGPRX2受体激活的IgE非依赖性途径与CSU疾病的发病机制有关。靶向肥大细胞活化的IgE依赖性和IgE非依赖性模式的药物有可能在更广泛的患者群体中起作用或显示出更大的症状改善。

About AK006 AK006 is a humanized IgG1 monoclonal antibody which activates the inhibitory receptor Siglec-6. Siglec-6 is found on the surface of mature mast cells and offers a way to selectively target mast cells. In preclinical experiments, AK006 inhibits IgE-dependent and IgE-independent mast cell activation including activation through IgE, MRGPRX2 and KIT receptors.

关于AK006 AK006是一种人源化IgG1单克隆抗体，可激活抑制性受体Siglec-6。Siglec-6存在于成熟肥大细胞的表面，为选择性靶向肥大细胞提供了一种方法。在临床前实验中，AK006抑制IgE依赖性和IgE非依赖性肥大细胞活化，包括通过IgE，MRGPRX2和KIT受体激活。

In these experiments, AK006 drives deep mast cell inhibition and, in addition to its inhibitory activity, can reduce mast cell numbers via antibody.

在这些实验中，AK006驱动深度肥大细胞抑制，除了其抑制活性外，还可以通过抗体减少肥大细胞数量。