Data of ASTONISH Phase 2 trial in septic shock patients is published in 《靠谱的电子游戏排行榜》 and data of ESSENTIAL Phase 2 study in critically ill COVID-19 patients is published in eClinicalMedicine.
Both studies show that a therapeutic intervention with nangibotide can control the TREM-1 pathway in major life-threatening immune dysregulations caused by severe infections, 无论是感染性休克还是严重的COVID-19, 从而改善患者的预后.
Inotrem, an advanced clinical stage biotech company specializing in immunotherapies for acute and chronic inflammatory conditions, announced today the publication of the results of two phase 2 clinical studies in the 《靠谱的电子游戏排行榜》 and in eClinicalMedicine. The first article presents the ASTONISH Phase 2b trial in septic shock patients and the second one the ESSENTIAL Phase 2 trial for the treatment of critically ill COVID-19 patients. Both studies reveal that the TREM-1 pathway plays a central role in major life-threatening immune dysregulations caused by severe infections, 无论是感染性休克还是严重的COVID-19. The findings presented further validate Inotrem’s innovative approach to treat inflammatory diseases by targeting TREM-1.
这两项研究表明，纳米肽, 目标是TREM-1, is pathogen agnostic and has the potential to treat those very severe inflammatory conditions caused by both viral and bacterial infections. Both studies highlight the potential of nangibotide in the treatment of septic shock patients and of patients with severe forms of COVID-19 with a biomarker guided approach using soluble TREM-1 as predictive marker of response to targeted therapy.
The first manuscript in 《靠谱的电子游戏排行榜》 is entitled “Prospective evaluation of the efficacy, 安全, 以及纳米肽生物标志物的最佳富集策略, TREM-1抑制剂, 对于感染性休克患者:双盲, 随机, 控制, 2b期试验”，并公布了355名感染性休克患者的结果. The primary outcome was the change in SOFA at day 5 compared to placebo in the pre-defined high soluble TREM-1 (≥ 400 pg/ml) group and in the overall population. Planned evaluation of the optimal sTREM-1 cut-off revealed increased clinically relevant benefits of high dose nangibotide at higher cutoffs (sTREM-1 ≥ 532 pg/ml). 稿件可通过以下链接访问: 《靠谱的电子游戏排行榜》.
《靠谱电子游戏排行》第二稿, entitled “Evaluation of the efficacy and 安全 of TREM-1 inhibition with nangibotide in patients with COVID19 receiving respiratory support: results of the ESSENTIAL 随机, double-blind trial” presents the Phase 2 results obtained in 220 COVID-19 patients receiving ventilatory support. 在这项研究中, Nangibotide对疾病的临床进展有显著的积极影响, 以及呼吸衰竭的严重程度, 继发感染率，尤其是死亡率. 该试验表明，sTREM-1是严重COVID-19预后的有效预后标志物. 稿件可通过以下链接访问: eClinicalMedicine.
“Nangibotide is the first TREM-1 inhibitor and has the potential to become the first causal treatment of life-threatening immune dysregulations. 这是一个医疗需求未得到满足的地区。” said 教授essor Bruno François, Limoges University Hospital, and lead author on the two manuscripts.
“We are excited to see this data published in 《靠谱的电子游戏排行榜》 and in eClinicalMedicine, 我们领域最权威的两本同行评议医学期刊. These two publications come as a strong recognition of Inotrem’s innovative scientific leadership regarding the role of the TREM-1 pathway and of our solid therapeutic approaches” intrem的首席执行官斯文·齐默尔曼说. “We look forward to bringing this potential new treatment option to patients suffering from severe and often fatal inflammatory conditions.”
关于nangibotide
Nangibotide is TREM-1抑制剂 peptide with the potential to restore appropriate inflammatory response, 血管功能, 提高脓毒性休克后的存活率. Nangibotide是活性成分LR12的制剂, 哪一个是化学合成的12个氨基酸的肽. LR12是一种特异性TREM-1抑制剂, 作为诱饵受体，干扰TREM-1及其配体的结合. 在临床前感染性休克模型中, Nangibotide能够恢复适当的炎症反应, 血管功能, 提高了动物在感染性休克后的存活率. Nangibotide in septic shock has been granted the fast-track status in September 2019 by the FDA and the PRIME status in 2017 by the EMA.
关于ASTONISH研究
的功效, Safety and Tolerability of nangibotide in Patients with Septic Shock (ASTONISH) phase 2b trial is a Randomized, 双盲, 安慰剂控制剂量选择研究在欧洲和美国进行. 该研究比较了nangibotide在两种不同剂量下的效果.3和1mg/kg/h连续I.v. 输注3 - 5天)对比标准治疗. Results for Phase IIb ASTONISH clinical trial in septic shock patients were disclosed for the first time at the International Sepsis Forum held in Barcelona on October 13. 2022.
关于ESSENTIAL Study
ESSENTIAL ii期试验是一项评估疗效的双盲随机对照试验, 安全, 与安慰剂相比，奈吉肽的最佳治疗人群(1.0 mg/kg/h). The study was stopped after 220 patients had been recruited; of them, 其中219例纳入了mITT分析. Patients aged 18-75 years were eligible within 7 days of SARS-CoV-2 documentation and within 48 hours of onset invasive or non-invasive respiratory support because of COVID-19-related ARDS. ESSENTIAL data were disclosed for the first time at the ESICM meeting held in Paris in October 25. 2022.
关于Inotrem
Inotrem年代.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. 通过其专有技术平台, Inotrem公司开发了同类首创的TREM-1抑制剂, nangibotide, 具有潜在的应用在一些治疗指征，如感染性休克, 严重的COVID-19和心肌梗死. 并行, Inotrem has also launched an antibody-based program to develop a new therapeutic modality targeting chronic inflammatory diseases. 该公司由Jean-Jacques Garaud博士于2013年创立, 罗氏集团的前研究和早期开发主管, 教授. ssambastien Gibot和Marc推导博士. intrem得到了欧洲和北美领先的支持