Swiss bioJAK1 inhibitor treatment of ulcerative colitis global Phase II study reached...

On February 4, Ruishi Bio announced the success of the global Phase II clinical study AMBER2 (NCT03675477) for the treatment of ulcerative colitis, the first highly selective JAK1 inhibitor SHR0302 tablet with independent intellectual property rights in China, reaching the primary and critical secondary endpoints of the trial.
This is the second time that SHR0302 has achieved positive results following the encouraging positive results of the specific dermatitis Phase II (QUARTZ2) clinical study in October 2020, demonstrating the great potential of Raytheon's JAK1 inhibitors to develop a wide range of adaptations in the field of autoimmune diseases.
ulcerative colitis is a chronic and recurrent disease whose pathogenesis is not yet clear and is generally recognized as closely related to autoimmunity of the large intestine mucous membranes.
diagnosis of the disease is relatively difficult, the course of the disease is long, and can lead to serious complications, some patients need surgical treatment, seriously affecting the quality of life of patients.
more than two million people worldwide suffering from ulcerative colitis, and the incidence rate in China has increased year by year in recent years.
In addition to 5-aminoic acid, glucosal hormones, immunomodulants and other basic therapeutic drugs, listed or in the study of biological agents have anti-TNF alpha, IL-12/23 and so on, but there is still a low clinical response rate or high recurrence rate of unsatisfactory clinical needs.
at the same time small molecular drugs oral easy to administration, suitable for long-term treatment of patients.
there is currently no treatment in China for moderate to severe ulcerative colitis of small molecules targeted drugs have been approved.
SHR0302 of Ruishi Bio is at the forefront of domestic research and development in this field.
AMBER2 is a randomized, double-blind, placebo-controlled, global multi-center clinical study conducted in 84 research centers in China, the United States and Europe.
was randomly assigned to four groups of 164 adult subjects with poor response to routine treatment and disease progression: oral 8mg once a day (QD), 4mg twice a day (BID), 4mg once a day (QD) SHR0302 tablets or placebo.
percentage of subjects who reached clinical response when the main endpoint of the AMBER2 trial was week 8.
data showed that the 8mg QD, 4mg BID, and 4mg QD groups were statistically significant (46.3%, 46.3%, 43.9% vs26.8%) compared to the placebo group in the 8th week of induction therapy.
, compared with the placebo group, in terms of clinical remission rate, each treatment group (8mg QD was 22.0%; 4mg BID=24.4%; There were significant statistical differences of 4mg QD of 24.4% and placebo of 4.9%)
clinical remission rate is also the evaluation index of the main endpoint of ulcerative colitis clinical trials recommended by the FDA in the United States.
safety, SHR0302's good tolerance was again validated in this study.
of adverse events (TEAEs) during treatment in each treatment group was comparable to that of the placebo group.
no tumors, deaths, thromboembolism-related, and significant cardiovascular-related adverse events were reported during the 8-week induced treatment period.
164 subjects reported a total of 6 cases of severe adverse events during treatment, 2 from the 8mg QD group, 2 from the 4mg QD group and 2 from the placebo group.
found no new security risks.
results are consistent with the drug properties of SHR0302 as a highly selective JAK1 inhibitor.
amBER2 showed once again that SHR0302 tablets have the potential to play an important role in the treatment of autoimmune diseases.
about SHR0302JAK is a member of the cytoplasm tyrosine kinase family, a total of JAK1, JAK2, JAK3, TYK2 four subtypes.
signal paths mediated by JAK, such as JAK-STAT path, MAPK path and P13k-AKT path, are associated with processes such as cell proliferation, differentiation, apoptosis, and inflammation.
including leukemia, bone marrow fibrosis and other blood-related diseases, as well as rheumatoid arthritis, strong spina bifia and other autoimmune diseases, are closely related to JAK-mediated signaling path.
, the JAK kinase family has become an important target for the treatment of these diseases.
SHR0302 is a highly selective JAK1 inhibitor, an innovative drug developed by China, with two dosage forms of oral tablets and external preparations, the first of its kind in China.
is conducting several SHR0302 clinical studies worldwide on a variety of immune inflammatory diseases, including specific dermatitis, ulcerative colitis, Crohn's disease and baldness.
SHR0302 has a higher selectivity than pan-JAK inhibitors, making it potential to play an important role in the treatment of ulcerative colitis.
About ulcerative colitis ulcerative colitis is an inflammatory bowel disease, clinical manifestations of persistent or recurrent diarrhea, mucus pus with abdominal pain, acute weight and varying degrees of systemic symptoms.
can be seen in any age group, the peak age of the disease is 20-49 years old, the difference between men and women is not obvious.
in recent years, the incidence rate in China is gradually increasing.
patients with ulcerative colitis currently have limited treatment methods, limited efficacy of existing drugs, and drug side effects have a great impact on patients, high recurrence rate after treatment.
the disease has long affected the quality of life of tens of thousands of patients and can lead to life-threatening complications including toxic large colons, perforation of the intestines, lower digestive tract bleeding, cancerous changes, and many serious patients require a full colonectomy.
so clinically urgent need for effective and safe drugs to treat ulcerative colitis this persistent disease.
JAK inhibitors improve the condition of ulcerative colitis patients by affecting cell signaling path path, because of its exact efficacy, has become one of the hot research topics in recent years.
currently the only JAK inhibitor to be approved for the disease abroad, created new hope for treatment.
SHR0302 as a highly selective JAK1 inhibitor, the expected efficacy and safety will be further enhanced, with the potential to play an important role in the treatment of autoimmune diseases.
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