LA JOLLA, Calif.--(BUSINESS WIRE)--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced an update on multi-cytokine programs EQ101 in development for the treatment of alopecia areata, EQ102 in development for the treatment of celiac disease, and EQ302, a new orally delivered multi-cytokine inhibitor..

加利福尼亚州拉霍亚市——（商业新闻短讯）——Equillium，Inc.（纳斯达克：EQ）是一家临床阶段生物技术公司，专注于开发治疗严重自身免疫性和炎症性疾病的新型疗法，今天宣布了用于治疗斑秃的多细胞因子计划EQ101、用于治疗乳糜泻的EQ102和EQ302的最新进展，一种新型口服多细胞因子抑制剂。。

“We are pleased to have completed enrollment of the EQ101 Phase 2 study in alopecia areata,” said Bruce Steel, chief executive officer at Equillium. “We have enrolled a total of 36 patients in the study, of which 13, or 36 percent, had very severe alopecia areata. These patients are in need of new treatments that may have an improved safety profile compared to recently approved JAK inhibitors.

Equillium首席执行官布鲁斯·斯蒂尔（BruceSteel）表示：“我们很高兴完成了斑秃EQ101第二阶段研究的注册。”。“我们共招募了36名患者参与研究，其中13名（36%）患有非常严重的斑秃。与最近批准的JAK抑制剂相比，这些患者需要新的治疗方法，可能具有更好的安全性。

While the study remains ongoing, to date EQ101 has been well tolerated over the 24-week dosing period. We expect to announce top-line data in Q2 2024.”.

虽然研究仍在进行中，但迄今为止，EQ101在24周的给药期内耐受性良好。我们预计将在2024年第二季度公布顶线数据。”。

EQ101 Alopecia Areata Phase 2 Study Baseline Characteristics:

EQ101斑秃2期研究基线特征：

36 patients enrolled:

登记的36名患者：

17 male and 19 female; 64% Caucasian

男17例，女19例；64%的高加索人

Age range of 18 to 60 years (mean age 38.2 years)

年龄范围18至60岁（平均年龄38.2岁）

Disease severity of patients at enrollment as defined by Severity of ALopecia Tool (SALT):

登记时患者的疾病严重程度由脱发工具（SALT）的严重程度定义：

Mean SALT score of 76

平均SALT得分为76

17% Moderate (SALT score 35 to 49)

17%中等（SALT得分35至49）

50% Severe (SALT score 50 to 94)

50%严重（SALT评分50至94）

33% Very Severe (SALT score > 95%)

33%非常严重（SALT评分>95%）

27 patients (75%) had been on previous treatments with 11 of those patients having history of oral treatments (including steroids, minoxidil, methotrexate, mycophenolate mofetil) and one patient having previous treatment with a systemic JAK inhibitor

27名患者（75%）曾接受过治疗，其中11名患者有口服治疗史（包括类固醇、米诺地尔、甲氨蝶呤、霉酚酸酯），1名患者曾接受过全身JAK抑制剂治疗

EQ102 & EQ302

EQ102和EQ302

“EQ102 is a first-in-class, bi-specific inhibitor of IL-15 and IL-21, two cytokines central to T and B cell activity, that exhibit biological synergy driving aggressive inflammatory responses in a number of gastrointestinal and skin diseases, highlighting the importance of dual inhibition,” said Steve Connelly, chief scientific officer at Equillium.

Equillium首席科学官史蒂夫·康奈利（SteveConnelly）说：“EQ102是IL-15和IL-21的第一类双特异性抑制剂，这两种细胞因子是T细胞和B细胞活性的核心，它们在许多胃肠道和皮肤疾病中表现出生物协同作用，驱动积极的炎症反应，突出了双重抑制的重要性。”。

“While EQ102 was generally well tolerated and demonstrated pharmacodynamic activity in the SAD/MAD portions of the study, the bioavailability of this initial formulation was lower than expected. Given our recent progress with EQ302, a potential first-in-class, second generation, orally delivered stapled peptide targeting IL-15 and IL-21, we intend to transition away from further developing EQ102, to advance EQ302 towards the clinic for the potential treatment of patients with gastrointestinal and skin diseases.

“虽然EQ102通常耐受性良好，并且在研究的SAD/MAD部分显示出药效学活性，但这种初始制剂的生物利用度低于预期。鉴于我们最近在EQ302方面取得的进展，EQ302是一种潜在的一流的第二代口服靶向IL-15和IL-21的钉合肽，我们打算不再进一步开发EQ102，将EQ302推向临床，以潜在治疗胃肠道和皮肤病患者。

Preclinical and translational data have demonstrated that EQ302 has increased potency compared to EQ102, is both stable and permeable in the gut, and can be further modified for optimal systemic or gut-restricted activity. Based on the superior product profile of EQ302, and the significant clinical and commercial advantages of orally delivered therapies in these disease settings, we believe advancing EQ302 is a better long-term strategy.

临床前和翻译数据表明，与EQ102相比，EQ302具有更高的效力，在肠道中既稳定又可渗透，并且可以进一步修饰以获得最佳的全身或肠道限制活性。基于EQ302优越的产品概况，以及口服疗法在这些疾病环境中的显着临床和商业优势，我们认为推进EQ302是一种更好的长期策略。

This development also illustrates the utility and modularity of our multi-cytokine platform in generating novel, first-in-class therapeutic candidates.”.

这一发展也说明了我们的多细胞因子平台在产生新型一流治疗候选药物方面的实用性和模块性。”。

About Equillium

关于Equillium

Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways.

Equillium是一家临床阶段的生物技术公司，利用对免疫生物学的深入了解，开发新的治疗方法，以治疗严重的自身免疫性和炎症性疾病，并满足高度未满足的医疗需求。该公司的管道由以下新型一流的免疫调节资产和针对免疫炎症途径的产品平台组成。

EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata being conducted in Australia and New Zealand by Equillium’s Australian subsidiary as the trial sponsor. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21; currently in pre-clinical development.

EQ101：靶向IL-2，IL-9和IL-15的选择性三特异性细胞因子抑制剂；目前正在由Equillium的澳大利亚子公司作为试验赞助商在澳大利亚和新西兰进行的斑秃患者的2期概念验证临床研究中进行评估。EQ302：靶向IL-15和IL-21的口服递送的选择性双特异性细胞因子抑制剂；目前正在进行临床前开发。

The multi-cytokine platform: generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and a Phase 1b clinical study of patients with lupus/lupus nephritis.

多细胞因子平台：产生合理设计的复合肽，其在共享受体水平选择性阻断关键细胞因子，靶向致病性细胞因子冗余和协同作用，同时保留非致病性信号传导。伊托珠单抗：一种靶向CD6-ALCAM信号通路的单克隆抗体，在调节效应T细胞中起着核心作用；目前正在评估急性移植物抗宿主病（aGVHD）患者的3期临床研究和狼疮/狼疮性肾炎患者的1b期临床研究。

Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited and has entered a strategic partnership with Ono Pharmaceutical Co., Ltd., for the development and commercialization of itolizumab under an option and asset purchase agreement..

Equillium通过与Biocon Limited的独家合作关系获得了伊托珠单抗的权利，并与Ono Pharmaceutical Co.，Ltd.建立了战略合作伙伴关系，根据期权和资产购买协议开发和商业化伊托珠单抗。。

For more information, visit www.equilliumbio.com.

For more information, visit www.equilliumbio.com.

Forward Looking Statements

前瞻性声明

Statements contained in this press release regarding matters that are not historical facts are “forward-looking Statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “could”, “continue”, “expect”, “estimate”, “may”, “plan”, “outlook”, “future” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters.

本新闻稿中关于非历史事实的声明是1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。前瞻性陈述可以通过使用诸如“预期”、“相信”、“可能”、“继续”、“预期”、“估计”、“可能”、“计划”、“展望”、“未来”和“项目”等词语以及预测或指示未来事件或趋势或不属于历史事项陈述的其他类似表达来识别。

These statements include, but are not limited to, statements regarding Equillium’s plans for developing EQ101 and EQ302 and the expected timeline for topline data for the EQ101 Phase 2 study, the plan to advance EQ302 into the clinic, the potential for EQ 302 to be a first-in-class therapeutic candidate, the potential benefits of EQ101 and EQ302, and the belief that advancing EQ302 is a better long-term strategy.

这些声明包括但不限于关于Equillium开发EQ101和EQ302的计划以及EQ101第二阶段研究的topline数据的预期时间表的声明，将EQ302推进临床的计划，EQ 302成为一流治疗候选人的潜力，EQ101和EQ302的潜在益处，并且相信推进EQ302是一个更好的长期战略。

Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; whether the advancement of EQ302 will be a better long-term strategy; Equillium’s ability to execute its plans and strategies; the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as pat.

由于此类报表存在风险和不确定性，其中许多不在Equillium的控制范围内，因此实际结果可能与此类前瞻性报表明示或暗示的结果存在重大差异。导致前瞻性陈述不确定性的风险包括：Equillium执行其计划和战略的能力；与进行临床和临床前研究有关的风险；临床和临床前研究的结果是否会验证和支持Equillium候选产品的安全性和有效性；EQ302的推进是否是一个更好的长期战略；Equillium执行其计划和战略的能力；临床研究的中期结果不一定能预测最终结果，并且一个或多个临床结果可能会随着pat发生实质性变化的风险。