– AK006 achieved serum concentrations consistent with levels demonstrating inhibitory activity in preclinical experiments –

–AK006的血清浓度与临床前实验中证明具有抑制活性的水平一致–

– Skin biopsies from subjects treated with AK006 show high receptor occupancy –

–接受AK006治疗的受试者的皮肤活检显示受体占有率很高–

– AK006 was well-tolerated with a favorable safety profile –

–AK006耐受性良好，安全性良好–

SAN CARLOS, Calif., June 25, 2024 (GLOBE NEWSWIRE) -- Allakos, Inc.  (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven diseases, today announced positive results from the single and multiple ascending Phase 1 study of intravenous (IV) AK006 in healthy volunteers.

加利福尼亚州圣卡洛斯，2024年6月25日（环球通讯社）--Allakos，Inc.（纳斯达克：ALLK），一家开发AK006治疗肥大细胞驱动疾病的生物技术公司，今天宣布了健康志愿者静脉注射（IV）AK006的单次和多次上升1期研究的积极结果。

AK006 is a Siglec-6 monoclonal antibody that selectively inhibits mast cells. Inappropriate activation of mast cells has been identified as a pathogenic driver of multiple diseases, including chronic spontaneous urticaria, food allergy and asthma..

AK006是一种Siglec-6单克隆抗体，可选择性抑制肥大细胞。肥大细胞的不适当激活已被确定为多种疾病的致病驱动因素，包括慢性自发性荨麻疹，食物过敏和哮喘。。

Phase 1 Study Results

第一阶段研究结果

Single and multiple IV doses of AK006 up to 720 mg were well tolerated with a favorable safety profile

单次和多次静脉注射高达720毫克的AK006耐受性良好，安全性良好

There were no serious adverse events (SAEs)

没有严重的不良事件（SAE）

There were no treatment emergent adverse events leading to discontinuation of AK006

没有治疗紧急不良事件导致AK006停药

There were no dose limiting toxicities

没有剂量限制性毒性

The most common adverse events occurring in subjects on AK006 were headache and dysmenorrhea, all of which were mild-to-moderate in severity

AK006受试者最常见的不良事件是头痛和痛经，所有这些都是轻度至中度的严重程度

AK006 showed dose linear exposure and with an estimated half-life of 21 days for the 720 mg IV dose

AK006显示剂量线性暴露，720 mg IV剂量的估计半衰期为21天

AK006 achieved serum concentrations consistent with those showing mast cell inhibition in preclinical experiments

AK006的血清浓度与临床前实验中肥大细胞抑制的血清浓度一致

Skin biopsies taken from AK006 treated healthy volunteers showed high levels of receptor occupancy confirming AK006 reaches skin tissue mast cells

Single ascending dose cohorts of AK006 ≥20mg showed a mean Siglec-6 receptor occupancy of >90% on mast cells at day 29

AK006≥20mg的单次递增剂量组在第29天显示肥大细胞上Siglec-6受体的平均占有率>90%

Phase 1 AK006 Study in Healthy Volunteers and Patients with Chronic Spontaneous Urticaria

健康志愿者和慢性自发性荨麻疹患者的1期AK006研究

AK006 is being studied in an ongoing Phase 1 single IV and subcutaneous (SC) ascending dose (SAD) and multiple IV ascending dose (MAD) trial that includes a randomized, double-blind, placebo-controlled CSU arm (NCT06072157). The data announced today are from Parts A and B of the randomized, double-blind, placebo-controlled SAD and MAD IV cohorts of the study.

AK006正在进行一项正在进行的1期单次IV和皮下（SC）递增剂量（SAD）和多次IV递增剂量（MAD）试验中进行研究，该试验包括随机，双盲，安慰剂对照的CSU组（NCT06072157）。今天公布的数据来自该研究的随机，双盲，安慰剂对照的SAD和MAD IV队列的A和B部分。

In these cohorts, healthy volunteers were randomized 6:2 to receive doses of intravenous AK006 or placebo. AK006 was tested across five single ascending doses (5, 20, 80, 240 and 720 mg) and three MAD (80, 240 and 720 mg monthly) dose cohorts. The primary objective was to evaluate the safety and tolerability of single ascending doses and multiple ascending IV doses of AK006 in healthy volunteers and to explore Siglec-6 receptor occupancy on mast cells in skin biopsy samples..

在这些队列中，健康志愿者以6:2的比例随机接受静脉注射AK006或安慰剂。AK006在五个单次递增剂量（5、20、80、240和720 mg）和三个MAD（每月80、240和720 mg）剂量组中进行了测试。主要目的是评估健康志愿者单次递增剂量和多次递增IV剂量AK006的安全性和耐受性，并探讨皮肤活检样本中肥大细胞上Siglec-6受体的占有率。。

AK006 is also being studied in an ongoing randomized, double-blind, placebo-controlled cohorts of healthy volunteers receiving SC AK006 and also in a cohort of patients with CSU receiving IV AK006. In the CSU cohort, approximately 60 adult patients with antihistamine refractory CSU (including patients with prior biologics treatment), will be randomized 2:1 to receive 720 mg of IV AK006 or placebo once every four weeks (Q4W).

AK006也正在接受SC AK006的健康志愿者和接受IV AK006的CSU患者队列中进行随机，双盲，安慰剂对照的研究。在CSU队列中，大约60名抗组胺药难治性CSU的成年患者（包括先前接受过生物制剂治疗的患者）将以2:1的比例随机接受720 mg静脉注射AK006或安慰剂，每四周一次（Q4W）。

The primary efficacy analysis will be the change in the urticaria activity score (UAS7) at week 14. Data from approximately 30 patients is expected at year end 2024..

主要疗效分析将是第14周荨麻疹活动评分（UAS7）的变化。预计2024年底将有大约30名患者的数据。。

About AK006

关于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.

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-dependent cellular phagocytosis in the presence of activated macrophages..

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，还可以在活化的巨噬细胞存在下通过抗体依赖性细胞吞噬作用减少肥大细胞数量。。

About Allakos

关于Allakos

Allakos is a clinical stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells.

Allakos是一家临床阶段生物技术公司，开发针对过敏，炎症和增殖性疾病免疫效应细胞上存在的免疫调节受体的治疗剂。激活这些免疫调节受体可以直接靶向参与疾病发病机制的细胞，并且在过敏和炎症的情况下，有可能导致炎症细胞的广泛抑制。

The Company’s most advanced antibody in ongoing clinical development is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed on mast cells. Mast cells are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs.

该公司正在进行的临床开发中最先进的抗体是AK006。AK006靶向Siglec-6，一种在肥大细胞上表达的抑制性受体。肥大细胞广泛分布于体内，在炎症反应中起着重要作用。不适当激活的肥大细胞已被确定为影响胃肠道，眼睛，皮肤，肺和其他器官的许多严重疾病的关键驱动因素。

In preclinical studies, AK006 appears to provide deep mast cell inhibition and, in addition to its inhibitory activity, reduce mast cell numbers. For more information, please visit the Company’s website at www.allakos.com..

在临床前研究中，AK006似乎提供了深层肥大细胞抑制作用，除了其抑制活性外，还减少了肥大细胞数量。欲了解更多信息，请访问公司网站www.allakos.com。。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ progress, business plans, areas of focus and preclinical research; enrollment in Allakos’s clinical study; timing and availability of data; the potential of AK006; and Allakos’ anticipated milestones.

本新闻稿包含经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所载1995年《私人证券诉讼改革法》所指的前瞻性声明。此类前瞻性陈述包括但不限于Allakos的进展、业务计划、重点领域和临床前研究；参加Allakos的临床研究；数据的时间和可用性；AK006的潜力；以及阿拉科斯的预期里程碑。

Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ stages of clinical drug development; Allakos’ ability to timely initiate and complete clinical trials for AK006; Allakos’ ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of clinical trials, regardless of the outcomes of preclinical testing or early-stage trials; Allakos’ ability to advance additional product candidates beyond AK006; uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring and related reduction in force; Allakos’ ability to accurately forecast financial results; Allakos’ ability to obtain additional capital to finance its operations, research and drug development; general economic and market conditions, both domestic and international; domestic and international regulatory obligations; and other risks.

这些陈述受到许多重要因素，风险和不确定性的影响，这些因素，风险和不确定性可能导致实际事件或结果与当前的期望和信念有重大差异，包括但不限于：Allakos的临床药物开发阶段；Allakos及时启动和完成AK006临床试验的能力；Allakos获得临床试验所需监管批准的能力；与临床试验患者登记相关的不确定性；Allakos在其临床试验中证明其候选产品具有足够的安全性和有效性的能力；与临床试验成功相关的不确定性，无论临床前试验或早期试验的结果如何；Allakos在AK006之外推进其他候选产品的能力；与Allakos实现其重组和相关裁员预期收益的能力相关的不确定性；Allakos准确预测财务结果的能力；Allakos获得额外资本以资助其运营、研究和药物开发的能力；国内外总体经济和市场状况；国内和国际监管义务；和其他风险。

Information .

信息。

Source: Allakos Inc.

资料来源：Allakos Inc。

Investor Contact:

投资者联系人：

Adam Tomasi, President

Adam Tomasi，总裁

Alex Schwartz, VP Strategic Finance and Investor Relations

战略财务和投资者关系副总裁Alex Schwartz

ir@allakos.com

ir@allakos.com

Media Contact:

媒体联系人：

Denise Powell

Denise Powell

denise@redhousecomms.com

denise@redhousecomms.com