EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study

欧洲皮肤病学与性病学学会：赛诺菲的brivekimig在二期a阶段研究中针对化脓性汗腺炎取得了积极成果。

In phase 2a study, brivekimig led to clinically meaningful improvements in primary and key secondary endpoints in biologic-naïve patients compared to placebo at week 16

在2a期研究中，与安慰剂相比，brivekimig 在第16周时使生物制剂初治患者的主要终点和关键次要终点均获得了具有临床意义的改善。

Dual-target Nanobody® VHH inhibiting TNF and OX40L being explored across a range of immune-mediated diseases

双靶点纳米抗体® VHH 抑制 TNF 和 OX40L，正在多种免疫介导的疾病中进行探索

Reaffirms Sanofi’s commitment to addressing underlying inflammation across complex, heterogeneous chronic skin diseases

重申了赛诺菲致力于解决复杂、异质性慢性皮肤病的根本炎症问题的承诺。

Paris, September 17, 2025

巴黎，2025年9月17日

. New data from the HS-OBTAIN phase 2a study (clinical study identifier:

。HS-OBTAIN 2a期研究（临床研究标识符：

NCT05849922

NCT05849922

) show that treatment with brivekimig led to clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) in patients naïve to biologics with moderate-to-severe hidradenitis suppurativa (HS). Brivekimig was well tolerated, with no serious adverse events.

）结果显示，对于未曾使用过生物制剂的中度至重度化脓性汗腺炎（HS）患者，使用Brivekimig治疗在主要终点指标——化脓性汗腺炎临床反应（HiSCR50）方面取得了具有临床意义的改善。Brivekimig耐受性良好，未发生严重不良事件。

The results will be shared in an oral presentation at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris. .

结果将在2025年巴黎举行的欧洲皮肤病与性病学会（EADV）大会上以口头报告的形式分享。

HS is a chronic and debilitating inflammatory skin disease characterized by painful cutaneous nodules, abscesses and draining tunnels. Approximately 196,000 adults in the EU live with HS.

HS 是一种慢性且使人衰弱的炎症性皮肤病，其特征是疼痛的皮肤结节、脓肿和引流隧道。欧盟约有 196,000 名成年人患有 HS。

“Despite the debilitating impact of HS, treatment options are unfortunately limited,” said

“尽管HS（化脓性汗腺炎）有致人衰弱的影响，但不幸的是治疗选择有限，”

Alexa B. Kimball

亚历克萨·B·金鲍尔

, MD, MPH, Professor of Dermatology, Harvard Medical School. “The phase 2a results presented at EADV indicate targeting TNF and OX40L pathways together with brivekimig may offer a promising strategy to reduce underlying inflammation, leading to improvement in HS symptoms.”

医学博士、公共卫生硕士、哈佛医学院皮肤病学教授。“在EADV上公布的2a期试验结果表明，通过brivekimig联合靶向TNF和OX40L通路可能提供一种有前景的策略，以减轻潜在的炎症，从而改善HS症状。”

Key results

关键结果

The HS-OBTAIN phase 2a study is a randomized, double-blind, placebo-controlled, proof-of-concept study assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS. The primary analysis population included biologic-naïve HS patients who were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks.

HS-OBTAIN 2a期研究是一项随机、双盲、安慰剂对照的概念验证研究，评估brivekimig在中重度HS成人患者中的疗效和安全性。主要分析人群包括生物制剂初治的HS患者，他们以2:1的比例随机接受每两周一次皮下注射150 mg brivekimig或安慰剂。

The following was observed at 16 weeks:.

以下是第16周的观察结果：

HiSCR50, defined as ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline, median response rates were

HiSCR50，定义为总脓肿和炎性结节数量减少≥50%，且相对于基线脓肿或引流瘘管数量没有增加，中位反应率为

67% in the brivekimig arm

67% 在布里维基米格组

(n=48) versus 37% (n=23) in the placebo arm (Bayesian primary analysis with estimated difference of 29%; 90% credible interval: 10%–47%; probability of superiority: 99.28%).

(n=48) 对比安慰剂组的 37% (n=23)（贝叶斯主要分析估计差异为 29%；90% 可信区间：10%-47%；优越概率：99.28%）。

Clinically meaningful improvements were also seen in more stringent secondary efficacy endpoints

在更严格的次要疗效终点方面，也观察到了有临床意义的改善。

of HiSCR75 and HiSCR90 for brivekimig versus placebo.

brivekimig与安慰剂对比的HiSCR75和HiSCR90。

54% of patients treated with brivekimig achieved HiSCR75

54%的患者使用brivekimig治疗后达到了HiSCR75。

versus 22% with placebo (estimated difference of 29%; 90% confidence interval [CI]: 11%–48%; p=0.0171).

与安慰剂组的22%相比（估计差异为29%；90%置信区间[CI]：11%-48%；p=0.0171）。

HiSCR90 was achieved by 31% of patients treated with brivekimig

31%的接受brivekimig治疗的患者达到了HiSCR90。

versus 9% with placebo (estimated difference of 20%; 90% CI: 5%–34%; p=0.0576).

与安慰剂组的9%相比（估计差异为20%；90%置信区间：5%-34%；p=0.0576）。

The mean percent change from baseline in

从基线的平均百分比变化

draining tunnel count was -56.0% for brivekimig

布里维基米格的排水隧道数量减少了56.0%

versus +10.9% for placebo (estimated difference of -67.0%; 90% CI: -105.2% to -28.8%; p=0.005).

与安慰剂的+10.9%相比（估计差异为-67.0%；90%置信区间：-105.2%至-28.8%；p=0.005）。

The most frequent adverse events (occurring in >10% of participants, and more frequent with brivekimig than with placebo) were nasopharyngitis and headache.

最常见的不良事件（发生在超过10%的参与者中，且使用brivekimig比安慰剂更频繁）是鼻咽炎和头痛。

“The positive early-stage results for brivekimig in HS presented at EADV exemplify our deep understanding of pathway biology and commitment to exploring novel platforms and technologies with the goal of delivering new treatment options that can address the complex, heterogeneous nature of chronic inflammatory skin diseases,” said .

“在EADV上展示的brivekimig在HS中的早期积极结果体现了我们对通路生物学的深刻理解，以及致力于探索新型平台和技术，旨在提供能够应对慢性炎症性皮肤病复杂、异质性的新治疗选择，”表示。

Alyssa Johnsen

阿丽莎·约翰森

, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi. “We are encouraged by these results and look forward to continuing to explore brivekimig, and the impact of dual TNF and OX40 ligand inhibition, on the inflammation driving the burdensome symptoms of HS.”

医学博士，赛诺菲免疫学与肿瘤学开发全球治疗领域负责人。“这些结果令我们备受鼓舞，我们期待继续探索布里维马吉以及双重TNF和OX40配体抑制对驱动HS沉重症状的炎症的影响。”

The use of brivekimig to treat HS is investigational and has not been evaluated by any regulatory authority.

使用brivekimig治疗HS属于研究性质，尚未得到任何监管机构的评估。

About brivekimig

关于brivekimig

Brivekimig is a dual-target Nanobody® molecule inhibiting the tumor necrosis factor and OX40-ligand, key immune regulators. It is being investigated for potential uses across a range of immune-mediated diseases and inflammatory disorders.

Brivekimig 是一种双靶点的纳米抗体®分子，能够抑制肿瘤坏死因子和 OX40 配体，这两种是关键的免疫调节因子。它正在被研究用于治疗多种免疫介导疾病和炎症性疾病的潜在用途。

About the HS-OBTAIN Study

关于HS-OBTAIN研究

HS-OBTAIN (clinical study identifier:

HS-OBTAIN（临床研究标识符：

NCT05849922

NCT05849922

) is a randomized, double-blind, placebo-controlled, proof-of-concept phase 2a study assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS.

）是一项随机、双盲、安慰剂对照的二期a阶段概念验证研究，评估brivekimig在中度至重度HS成人患者中的疗效和安全性。

Patients were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks for 16 weeks, followed by a 12-week open-label period and an 8-week safety follow-up. The primary efficacy endpoint was the percentage of biologic-naïve participants achieving HiSCR50 at week 16. The primary analysis was based on a Bayesian logistic regression model adjusted for Hurley Stage.

患者按2:1的比例随机接受每两周一次的布里维单抗150 mg或安慰剂皮下注射，持续16周，随后进入12周的开放标签期和8周的安全性随访。主要疗效终点是第16周时未使用过生物制剂的参与者达到HiSCR50的比例。主要分析基于调整了Hurley分期的贝叶斯逻辑回归模型。

Additional endpoints included HiSCR75, HiSCR90, and draining tunnel count at week 16 (with adjusted estimates and nominal p-values)..

其他终点包括HiSCR75、HiSCR90和第16周的引流隧道计数（经调整的估计值和名义p值）。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并实现引人注目的增长。我们凭借对免疫系统的深刻理解，发明能够治疗和保护全球数百万人的药物和疫苗，并通过创新的研发管线造福更多人群。我们的团队秉承一个使命：追逐科学奇迹以改善人们的生活；这激励我们通过应对当今最紧迫的医疗、环境和社会挑战，推动进步并为我们服务的人群和社区带来积极影响。