SPY-002

2026年6月16日，Spyre Therapeutics 宣布其抗 TL1A 抗体药物 SPY002 在溃疡性结肠炎（UC）的 II 期临床试验中取得积极顶线结果，全部主要终点均达标，为这家新锐生物科技公司在炎症性肠病领域的布局再添重要砝码。10.7 分！组织学改善创下领域新高 本次数据来自 Spyre 的 Skyline 临床试验项目，这是一个包含诱导和维持治疗的平台性试验，同时评估三款候选药物： SPY001：抗 α4β7 抗体（对标武田 Entyvio） SPY002：抗 TL1A 抗体（本次公布数据） SPY003：抗 IL-23 抗体（预计 Q3 公布数据） Skyline 试验 A 部分的 12 周初步结果显示，在中度至重度活动性溃疡性结肠炎患者中，SPY002 治疗组患者的 Robart 组织病理学指数（RHI）评分较基线水平显著降低 10.7 分，达到统计学显著性。 RHI 评分是目前溃疡性结肠炎领域广泛采用的组织学疾病活动度评估标准，评分降低意味着肠道组织炎症的实质性改善。 关键疗效数据一览： Spyre 公司强调，SPY002 在各项终点上的表现 "位居该疾病领域已报道数据的最高水平之列"。值得注意的是，10.7 分的 RHI 降幅甚至超过了此前 SPY001 创下的 9.2 分记录，展现出抗 TL1A 靶点在组织学改善方面的独特优势。安全性表现符合预期，联合疗法前景可期 安全性方面，SPY002 的安全性特征与 TL1A 抗体类别一致。在 48 名患者的队列中： 20 名受试者在诱导治疗期间出现治疗 emergent 不良事件 2 例严重不良事件，经判定与研究药物无关 Spyre 临床开发高级副总裁、Skyline 研究负责人 Deanna Nguyen 博士表示："SPY002 展现了适应症领先的 10.7 分 RHI 降低，以及与抗 TL1A 类别一致、且在所有治疗类别中位居前列的临床缓解和内镜改善结果。这些数据建立在我们令人印象深刻的 SPY001 结果之上，进一步强化了我们的核心理念 —— 优化的单药组分是潜在同类最优联合疗法的基石。" Mizuho 分析师在客户报告中特别强调了 SPY002 的疗效特征，认为当与 SPY001 联用时，有望实现 "潜在前所未有的诱导临床缓解率"。三管线齐发，剑指溃疡性结肠炎百亿市场 Spyre 的战略布局清晰可见：通过同时开发针对不同靶点的三款抗体药物，构建完整的溃疡性结肠炎治疗矩阵。 SPY001：直接对标武田制药的重磅药物 Entyvio（维多珠单抗），靶向相同的 α4β7 整合素表位 SPY002：靶向 TL1A，这是炎症性肠病中参与慢性炎症和纤维化的上游细胞因子 SPY003：靶向 IL-23，炎症性肠病领域的成熟靶点 按照计划，Spyre 将在2026 年第三季度公布 SPY003 的 A 部分结果，届时三款单药的概念验证数据将全部出炉，随后将进入试验 B 部分，评估两种剂量水平的单药治疗以及联合用药方案的安全性和有效性。 目前，Skyline试验B部分正在招募患者。随着三款候选药物数据的陆续公布，Spyre 正逐步兑现其 "通过优化单药 + 联合疗法重塑溃疡性结肠炎治疗格局" 的雄心。 信息来源：https://www.fiercebiotech.com/biotech/spyre-spies-another-edge-ulcerative-colitis-ambitions-phase-2-disease-reduction-win 识别微信二维码，添加抗体圈小编，符合条件者即可加入 抗体微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

SPY002 is one of three antibodies Spyre is testing out in ulcerative colitis. \n Spyre Therapeutics is fleshing out another pillar in its plan to take on the lucrative ulcerative colitis market with a positive phase 2 readout for its anti-TL1A antibody, SPY002. The data drop comes from Spyre’s Skyline program, a two-part induction and maintenance platform trial of SPY002 and two other candidates: Spyre’s anti-α4β7 antibody, SPY001, and its anti-IL23 antibody, SPY003. Part A of the phase 2 study involves a single dose level for each investigational therapy, while Part B will assess the safety and efficacy of two dose levels of the monotherapies and in combinations. Initial 12-week findings from Skyline Part A showed that SPY002 met all of the study’s key objectives in patients with moderately to severely active ulcerative colitis, Spyre said in a Monday release. More specifically, the drug prompted a statistically significant reduction of 10.7 points from baseline levels in patients’ Robart’s Histopathology Index (RHI) scores by week 12. RHI is a widely used scoring system that measures histological disease activity in ulcerative colitis. Additionally, secondary endpoints saw a clinical remission rate of 33% and an endoscopic improvement rate of 42%. The outcomes across SPY002’s endpoints are “among the highest reported” in the disease field, according to Spyre. The drug’s safety profile was consistent with that of the TL1A class, the company said. In the 48-patient cohort, 20 participants experienced treatment-emergent adverse events during the induction treatment period, with two serious events that were determined not related to the drug. “SPY002 demonstrated an indication-leading 10.7-point reduction in RHI and meaningful clinical remission and endoscopic outcomes in line with the anti-TL1A class and among the highest across therapeutic classes,” Spyre’s SVP of clinical development and Skyline study lead, Deanna Nguyen, M.D., explained in the release, adding that the findings “build upon our impressive SPY001 results and reinforce our thesis that optimized monotherapy components are the foundation for potentially best-in-class combinations.”In a note to clients, Mizuho analysts highlighted the efficacy profile of SPY002, arguing the drug could deliver “potentially unprecedented induction clinical remission rates” when combined with SPY001.Back in April, Spyre announced that its SPY001 demonstrated a statistically significant 9.2-point reduction in patients’ RHI scores from baseline. In that part of the trial, the company reported a 40% clinical remission rate and a 51% endoscopic improvement rate. The company remains “on track” to report its SPY003 Part A results during the third quarter, Nguyen said, which would round out proof-of-concept results for its monotherapy components before getting into its combination arms in part B. Spyre is currently enrolling patients for part B of the study program. SPY001 was designed to specifically challenge Takeda’s leading Entyvio as the candidate targets the same epitope as Entyvio’s active ingredient, vedolizumab. SPY002, meanwhile, targets TL1A, which is an upstream cytokine implicated in chronic inflammation and fibrosis in inflammatory bowel disease.