FierceBiotechCodex · 实盘不做把握 6/10
北京时间·🕒 发布 02:08:00时区推断·⟳ 抓取 02:51:23·⚡ 决策 08-06 03:03:43 +12m20s·82.6 天前
Sanofi暂停SAR445399用于非囊性纤维化支气管扩张症的2期试验
SAR445399的NCFB 2期试验被暂停，新增方向对Sanofi为轻微负面。
📄 原文FierceBiotech↗ 原文
Sanofi suspends chronic lung disease phase 2 study, tied to ‘strategic business reasons’
Sanofi halted a phase 2 trial testing a monoclonal antibody, SAR445399, in non-cystic fibrosis bronchiectasis, Fierce B…
不做 Sanofi（SNY.US）
单个早期2期适应症暂停且非安全性原因，相对Sanofi体量太小，不满足做空强催化；也无同向多头机会。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
消息传播链
- Fierce Biotech称该试验于7月29日被正式报告为halted。
- Fierce Biotech报道Sanofi暂停SAR445399的NCFB 2期试验，公司称并非安全性原因。
关键理由
- SAR445399的NCFB 2期试验被暂停，新增方向对Sanofi为轻微负面。
- 公司称暂停来自全公司组合审查且非安全性问题，削弱了事件的惩罚性。
- 该项目仍处早期2期、临床入组规模约70人，相对Sanofi整体收入和市值过小，难以形成公司级短线交易。
主要风险
- Sanofi近期连续砍掉或失败多个管线资产，研发组合信心偏弱。
- 若后续公司进一步终止SAR445399其他适应症，才可能需要重新评估。
反向证据
- 做空前查反向 · 来源 web · 日期 2026-08-05 · 影响 weakens
公司明确表示不是安全性问题，降低该事件对核心研发平台和商业化预期的外溢损害。
检索:Sanofi SAR445399 halt safety concerns strategic business reasons 原文 ↗
原文全文
展开原文 · 2,413 字
Sanofi halted a phase 2 trial testing a monoclonal antibody, SAR445399, in non-cystic fibrosis bronchiectasis, Fierce Biotech has learned.
The trial, which began only back in April, was a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score following treatment with SAR445399 compared with placebo in adults aged 18 to 80 years with NCFB, a chronic lung disease. The trial was officially reported as halted on July 29, the day before Sanofi’s second-quarter earnings call.
The decision to pause the trial was made “as part of a company-wide portfolio review for strategic business reasons,” and not due to safety concerns, a Sanofi spokesperson told Fierce.
The move to pause the NCFB trial comes during a trying time for Sanofi following a year filled with a series of trial fails. In February, the French pharma ousted CEO Paul Hudson and appointed Merck KGaA leader Belén Garijo, M.D., Ph.D., to steer the ship.
Since then, Garijo has been doing a deep dive on correcting the company’s strewn R&D and clinical strategies. On July 24, Sanofi scrapped amlitelimab for atopic dermatitis, despite its lore as being a potential $5 billion blockbuster. During its second-quarter report, the company abandoned two more assets, balinatunfib and itepekimab, following failed trial results in psoriasis and chronic obstructive pulmonary disease, respectively.
SAR445399, only first revealed by Sanofi in 2023, is an anti-interleukin-1 receptor 3 monoclonal antibody developed to block the interleukin 1, 33, and 36 cytokine pathways. These pathways can be important in chronic immune-related dermatologic diseases, such as atopic dermatitis and hidradenitis suppurativa, as well as respiratory conditions, such as NCFB.
NCFB affects roughly half a million people in the U.S., with a global incidence of greater than one million cases. In August 2025, Insmed received FDA approval for Brinsupri, a DPP1 inhibitor targeting neutrophil activation, for treatment of NCFB in adults and kids ages 12 and older. The British biotech Infex Therapeutics showed promising NCFB phase 2a data using their monoclonal antibody, INFEX702, which acts by disabling Pseudomonas aeruginosa, a bacteria known to be a major pathogen of NCFB.
Sanofi is currently running a separate phase 2 study testing SAR445399 as a potential treatment for the inflammatory skin condition hidradenitis suppurativa.
The trial, which began only back in April, was a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score following treatment with SAR445399 compared with placebo in adults aged 18 to 80 years with NCFB, a chronic lung disease. The trial was officially reported as halted on July 29, the day before Sanofi’s second-quarter earnings call.
The decision to pause the trial was made “as part of a company-wide portfolio review for strategic business reasons,” and not due to safety concerns, a Sanofi spokesperson told Fierce.
The move to pause the NCFB trial comes during a trying time for Sanofi following a year filled with a series of trial fails. In February, the French pharma ousted CEO Paul Hudson and appointed Merck KGaA leader Belén Garijo, M.D., Ph.D., to steer the ship.
Since then, Garijo has been doing a deep dive on correcting the company’s strewn R&D and clinical strategies. On July 24, Sanofi scrapped amlitelimab for atopic dermatitis, despite its lore as being a potential $5 billion blockbuster. During its second-quarter report, the company abandoned two more assets, balinatunfib and itepekimab, following failed trial results in psoriasis and chronic obstructive pulmonary disease, respectively.
SAR445399, only first revealed by Sanofi in 2023, is an anti-interleukin-1 receptor 3 monoclonal antibody developed to block the interleukin 1, 33, and 36 cytokine pathways. These pathways can be important in chronic immune-related dermatologic diseases, such as atopic dermatitis and hidradenitis suppurativa, as well as respiratory conditions, such as NCFB.
NCFB affects roughly half a million people in the U.S., with a global incidence of greater than one million cases. In August 2025, Insmed received FDA approval for Brinsupri, a DPP1 inhibitor targeting neutrophil activation, for treatment of NCFB in adults and kids ages 12 and older. The British biotech Infex Therapeutics showed promising NCFB phase 2a data using their monoclonal antibody, INFEX702, which acts by disabling Pseudomonas aeruginosa, a bacteria known to be a major pathogen of NCFB.
Sanofi is currently running a separate phase 2 study testing SAR445399 as a potential treatment for the inflammatory skin condition hidradenitis suppurativa.
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