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News on April 26, 2021 // --Tianjing Biotechnology (Shanghai) Co.
, Ltd.
(I-mab Biopharma, hereinafter referred to as "Tianjing Biopharma") recently announced the evaluation of a new anti-inflammatory drug olamkicept (sgp130Fc, also known as TJ301) for the treatment of active ulcerative colitis (UC) A positive top-line result of a phase 2 clinical study (NCT03235752)
.
This is a regional multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of intravenous infusion of olamkicept twice a week in the treatment of patients with active UC
.
, Ltd.
(I-mab Biopharma, hereinafter referred to as "Tianjing Biopharma") recently announced the evaluation of a new anti-inflammatory drug olamkicept (sgp130Fc, also known as TJ301) for the treatment of active ulcerative colitis (UC) A positive top-line result of a phase 2 clinical study (NCT03235752)
.
This is a regional multicenter, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of intravenous infusion of olamkicept twice a week in the treatment of patients with active UC
.
Olamkicept (TJ301) is the only selective IL-6 inhibitor in the clinical stage that works through a trans-signaling mechanism
.
IL-6 is an autoimmune disease (such as UC) and maintaining chronic inflammation propagation important driving factors
.
Olamkicept (TJ301) is the only selective IL-6 inhibitor in the clinical stage that works through a trans-signaling mechanism.
IL-6 is an autoimmune disease (such as UC) and maintaining chronic inflammation propagation important driving factors
.
.
self-immune
This phase 2 study is one of the first placebo-controlled, proof-of-concept studies of IL-6 inhibitors in UC.
The study has reached the primary endpoint and key secondary endpoints: (1) After 12 weeks of treatment, with placebo Compared with the drug group, the 600mg dose olamkicept group showed a significantly higher clinical response rate (p=0.
032) ; (2) Compared with the placebo group, the 600mg dose olamkicept group had a significantly higher proportion of patients achieving clinical remission and mucosal Healing (p<0.
001) , these are the two key secondary endpoints of the study
.
(3) Olamkicept is well tolerated and has acceptable safety
.
Significantly higher clinical response rate (p=0.The study has reached the primary endpoint and key secondary endpoints: (1) After 12 weeks of treatment, with placebo Compared with the drug group, the 600mg dose olamkicept group showed a significantly higher clinical response rate (p=0.
032) ; (2) Compared with the placebo group, the 600mg dose olamkicept group had a significantly higher proportion of patients achieving clinical remission and mucosal Healing (p<0.
001) , these are the two key secondary endpoints of the study
.
(3) Olamkicept is well tolerated and has acceptable safety
.
032) Significantly higher proportion of patients achieve clinical remission and mucosal healing (p<0.
001)
The detailed data analysis of the study in the United States Digestive Disease Week (DDW) and the European Crohn's disease and colitis organization in July 2021 of (ECCO) 2021 Nian May meeting published on
.
meeting.
Olamkicept action mode diagram (picture source: reference 2)
Professor Chen Minhu, the main researcher of the study, the deputy dean of the First Affiliated Hospital of Sun Yat-sen University, and the chief physician of the Department of Gastroenterology, said: "We are very pleased to see that through this successful Phase 2 study, olamkicept is targeted at safety and effectiveness.
Patients with active UC have shown significant clinical benefits
.
This is the first demonstration that blocking IL-6 through the trans-signaling pathway plays an important therapeutic role in UC
.
This study is for the further clinical development of this differentiated IL-6 blockade.
Hydrating agents provide confidence as a treatment option for UC and inflammatory bowel disease (IBD)
.
"
Patients with active UC have shown significant clinical benefits
.
This is the first demonstration that blocking IL-6 through the trans-signaling pathway plays an important therapeutic role in UC
.
This study is for the further clinical development of this differentiated IL-6 blockade.
Hydrating agents provide confidence as a treatment option for UC and inflammatory bowel disease (IBD)
.
"
Dr.
Shen Huaqiong, CEO of Tianjing Biotech, said: “Because the current drug treatments have significant side effects and will develop resistance over time, the treatment of inflammatory bowel disease (such as UC) has not been satisfied.
The positive Phase 2 clinical data supports our belief that olamkicept has the potential to become the standard treatment for UC, and we are excited about the prospect of exploring a wider global patient range and providing a new new treatment option
.
"
Shen Huaqiong, CEO of Tianjing Biotech, said: “Because the current drug treatments have significant side effects and will develop resistance over time, the treatment of inflammatory bowel disease (such as UC) has not been satisfied.
The positive Phase 2 clinical data supports our belief that olamkicept has the potential to become the standard treatment for UC, and we are excited about the prospect of exploring a wider global patient range and providing a new new treatment option
.
"
In November 2016, Horizon Biotech signed an agreement with Ferring Pharmaceuticals to obtain the exclusive license to develop and commercialize olamkicept in Greater China and South Korea
.
On April 23, 2021, the two parties signed a Memorandum of Understanding (MoU) to explore possible cooperation in the development and commercialization of olamkicept in the United States, Canada, the European Union and Japan
.
.
On April 23, 2021, the two parties signed a Memorandum of Understanding (MoU) to explore possible cooperation in the development and commercialization of olamkicept in the United States, Canada, the European Union and Japan
.
Classic IL-6R signaling pathway and IL-6 trans signaling pathway, IL-6/6R target new drugs (picture source: reference 3)
Olamkicept is a homodimer of a fusion protein consisting of the extracellular domain of human glycoprotein 130 (gp130) and the crystallizable fragment (Fc) of human IgG1
.
Olamkicept includes two extracellular regions of gp130, and is dimerized by the Fc part of human IgG1, which can capture the complex of IL-6 and soluble IL-6 receptor (IL-6R)
.
.
Olamkicept includes two extracellular regions of gp130, and is dimerized by the Fc part of human IgG1, which can capture the complex of IL-6 and soluble IL-6 receptor (IL-6R)
.
Olamkicept is the only selective inhibitor of IL6 trans-signaling pathway in clinical stage
.
Compared with other approved IL-6 or IL-6R antibody drugs, olamkicept has better safety because it does not affect the normal physiological functions of IL-6, such as the acute immune response in infection and metabolic regulation
.
.
Compared with other approved IL-6 or IL-6R antibody drugs, olamkicept has better safety because it does not affect the normal physiological functions of IL-6, such as the acute immune response in infection and metabolic regulation
.
olamkicept has the potential to become the treatment of UC and other IL-6 as the key inflammatory mediators of autoimmune best in class drug-induced diseases
.
Currently, the first indication developed by Tianjing Bio for olamkicept is UC, and the company also plans to develop other indications for IL-6-mediated inflammation
.
()
olamkicept has the potential to become the treatment of UC and other IL-6 as the key inflammatory mediators of autoimmune best in class drug-induced disease autoimmunity.
Currently, the first indication developed by Tianjing Bio for olamkicept is UC, and the company also plans to develop other indications for IL-6-mediated inflammation
.
()
Reference materials:
1.
I-Mab Announces Positive Topline Phase 2 Results for Olamkicept in Ulcerative Colitis
I-Mab Announces Positive Topline Phase 2 Results for Olamkicept in Ulcerative ColitisI-Mab Announces Positive Topline Phase 2 Results for Olamkicept in Ulcerative Colitis
2.
Stefan Schreiber, et al.
Therapeutic Interleukin 6 Trans-signaling Inhibition by Olamkicept (sgp130Fc) in Patients With Active Inflammatory Bowel Disease .
Gastroenterology, 2021, doi: 10.
1053/j.
gastro.
2021.
02.
062.
Therapeutic Interleukin 6 Trans-signaling Inhibition by Olamkicept (sgp130Fc) in Patients With Active Inflammatory Bowel DiseaseStefan Schreiber, et al.
Therapeutic Interleukin 6 Trans-signaling Inhibition by Olamkicept (sgp130Fc) in Patients With Active Inflammatory Bowel Disease .
Gastroenterology, 2021, doi: 10.
1053/j.
gastro.
2021.
02.
062.
3.
Jones SA, et al.
Interleukin 6: The biology behind the therapy .
Considerations Med 2018, doi:10.
1136/conmed-2018-000005
Interleukin 6: The biology behind the therapy Jones SA, et al.
Interleukin 6: The biology behind the therapy .
Considerations Med 2018, doi:10.
1136/conmed-2018-000005
