预约演示
更新于：2026-01-27
SOR-102
更新于：2026-01-27
概要
基本信息
药物类型 双特异性抗体 |
别名 SOR 102、SOR102 |
作用方式 抑制剂 |
作用机制 IL-23抑制剂(白细胞介素-23复合体抑制剂)、IL-23p19抑制剂(白细胞介素-23亚单位p19抑制剂)、TNF-α抑制剂(肿瘤坏死因子α抑制剂) |
非在研适应症- |
非在研机构- |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
登录后查看时间轴
关联
1
项与 SOR-102 相关的临床试验NCT06080048
A Ph I Randomized Double-Blind First-in-Human Single Ascending Dose & Multiple Dose Study to Investigate the Safety Tolerability and Pharmacokinetics of SOR102 in Healthy Adult Participants and Patient Volunteers With Mild to Severe Ulcerative Colitis
100 项与 SOR-102 相关的临床结果
登录后查看更多信息
100 项与 SOR-102 相关的转化医学
登录后查看更多信息
100 项与 SOR-102 相关的专利（医药）
登录后查看更多信息
1
项与 SOR-102 相关的文献（医药）2026-01-01Lancet Gastroenterology & Hepatology
Safety and pharmacokinetics of SOR102, an oral bispecific inhibitor of TNF and interleukin-23 in healthy participants and patients with ulcerative colitis: a first-in-human, double-blind, randomised, placebo-controlled, phase 1 trial
Article
作者: Sattler, Carlos ; Jairath, Vipul ; Roberts, Kevin J ; Gaemers, Ingrid ; Barbat, Sara ; Sands, Bruce E ; Wedel, Pamela ; Feagan, Brian G ; Benson, Jacqueline M ; Westfall, Matt ; Terry, Allyson Q ; Danese, Silvio ; Peyrin-Biroulet, Laurent ; D'Haens, Geert R
BACKGROUND:
SOR102 is an oral bispecific antibody comprised of single domain antibodies targeting TNF and interleukin (IL)-23p19. We aimed to assess the safety, pharmacokinetics, clinical, and biological activity of SOR102 in healthy participants and in patients with active ulcerative colitis.
METHODS:
This phase 1 first-in-human, double-blind, randomised, placebo-controlled, trial was done in the UK, Ukraine, and Georgia in clinical research centres. Central randomisation was by an interactive web response system and a randomisation scheme produced by an unmasked, independent statistician. In part 1, healthy participants were randomly assigned (6:2) to single ascending doses of SOR102 or placebo. In part 2, healthy participants were randomly assigned (8:2) to SOR102 or placebo twice daily for 7 days. In part 3, patients with mildly-to-severely active ulcerative colitis were randomly assigned (1:1:1) to once-daily or twice-daily SOR102 or placebo for 42 days. The primary objective was to evaluate the safety and tolerability of SOR102. Safety analyses were done on all participants or patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT06080048 and is complete.
FINDINGS:
From Oct 9, 2023, to Oct 16, 2024, 157 participants were assessed for eligibility, of whom 93 were excluded and 64 were randomly assigned to either SOR102 (n=48) or placebo (n=16) across all three parts of the study. In part 1, six participants were randomly assigned to receive SOR102 135 mg, six to receive SOR102 405 mg, six to receive SOR102 1215 mg, six to receive SOR102 3645 mg, and eight to receive placebo. In part 2, eight participants were randomly assigned to receive SOR102 1215 mg twice-daily and two to receive placebo. In part 3, seven patients with ulcerative colitis were randomly assigned to receive SOR102 810 mg once-daily, nine to receive the same dose twice-daily, and six to receive placebo. In part 1, treatment-emergent adverse events (TEAEs) occurred in three (13%) of 24 participants who received SOR102 (two in the SOR102 135 mg dose group and one in the SOR102 405 mg dose group; mild diarrhoea and moderate dysmenorrhoea both in a single participant in the SOR102 135 mg group and mild flatulence in a second participant in same group; mild dysmenorrhoea in one participant in the SOR102 405 mg group) compared with two (25%) of eight participants who received placebo (mild catheter site pain; mild headache). Only the TEAE of mild diarrhoea was deemed treatment-related. No TEAEs occurred in part 2. In part 3, at least one TEAE occurred in seven (44%) of 16 patients who received SOR102 (five in the SOR102 810 mg twice-daily dose group and two in the SOR102 810 mg once-daily dose group) and three (50%) of six patients who received placebo. Two patients in the SOR102 twice-daily group had TEAEs of worsening of ulcerative colitis (one of which was severe [the only serious TEAE reported] but not deemed treatment related), leading to study discontinuation. All other TEAEs were mild to moderate in nature. No clinically significant effect of SOR102 on electrocardiogram, vital signs, physical examination, or laboratory parameters was observed at any dose, or frequency of dosing, in any part of the study, and no deaths occurred. In part 3, by day 42, three (43%) of seven participants in the SOR102 once-daily group, five (56%) of nine patients in the SOR102 twice-daily group, and one (17%) of six patients in the placebo group had achieved a Mayo score clinical response, while two (29%) patients in the once-daily group, six (67%) in the twice-daily group, and two (33%) in the placebo group achieved a modified Mayo score clinical response. Three (43%) patients in the once-daily group, five (56%) in the twice-daily group, and none in the placebo group achieved symptomatic remission by day 42.
INTERPRETATION:
The favourable safety profile and preliminary evidence for efficacy support development of SOR102 for treatment of ulcerative colitis.
FUNDING:
Sorriso Pharmaceuticals.
100 项与 SOR-102 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 溃疡性结肠炎 | 临床2期 | - | - | |
| 克罗恩病 | 临床2期 | - | - |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1期 | 64 | SOR102 135 mg to 3645 mg, single dose (Part 1) | 範獵蓋積積齋鏇網鏇鹹(鏇顧鏇遞積衊夢餘淵簾) = 顧顧製鹹鏇齋糧簾範蓋 淵齋鏇艱糧鑰膚築範簾 (簾鏇衊淵蓋廠獵窪獵蓋 ) 更多 | 积极 | 2026-01-01 | ||
Placebo (Part 1) | 範獵蓋積積齋鏇網鏇鹹(鏇顧鏇遞積衊夢餘淵簾) = 網艱觸膚範獵膚鹽鑰簾 淵齋鏇艱糧鑰膚築範簾 (簾鏇衊淵蓋廠獵窪獵蓋 ) 更多 | ||||||
临床1期 | 22 | 鏇遞繭鏇衊獵選選獵範(築衊淵廠繭鏇顧網夢鏇) = 廠簾醖鬱網蓋夢遞鬱醖 觸齋鹽壓膚糧製構範獵 (糧膚憲醖獵壓鹽遞鹹積 ) 更多 | 积极 | 2025-02-27 | |||
Placebo (ITT) | 鏇遞繭鏇衊獵選選獵範(築衊淵廠繭鏇顧網夢鏇) = 鹽壓積鏇遞積範遞鑰觸 觸齋鹽壓膚糧製構範獵 (糧膚憲醖獵壓鹽遞鹹積 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用