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News on April 26, 2021 // --Bristol- Myers Squibb (BMS) recently announced the evaluation of a new anti-inflammatory drug deucravacitinib (BMS-986165) in the treatment of moderate to severe plaque psoriasis at the 2021 American Academy of Dermatology Virtual Conference Experience (AAD VMX) Positive results of the patient's 2 key phase 3 studies (POETYK PSO-1, POETYK PSO-2)
.
Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of inhibiting IL-12, IL-23, and type 1 interferon pathways.
This drug is the first and only TYK2 inhibitor to be evaluated in clinical research for the treatment of various immune-mediated diseases
.
meeting.
Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of inhibiting IL-12, IL-23, and type 1 interferon pathways.
This drug is the first and only TYK2 inhibitor to be evaluated in clinical research for the treatment of various immune-mediated diseases
.
The results announced at the meeting showed that the two studies reached the common primary and secondary endpoints: it was confirmed that deucravacitinib (6 mg, once a day) compared with placebo and Otezla (apremilast, 30 mg, twice a day) Significant efficacy and superiority , including a significantly higher proportion of patients achieving a psoriasis area and severity index improvement of at least 75% from baseline (PASI75) and static physician overall assessment (sPGA) at week 16 compared with placebo and Otezla ) The score is complete or almost complete removal of skin lesions (sPGA 0/1).
Compared with Otezla, a higher proportion of patients reached PASI75 and sPGA 0/1 at week 24 and maintained until week 52
.
In this study, deucravacitinib was safe and well tolerated
.
Both studies reached the common primary and secondary endpoints: confirmed the significant efficacy and superiority of deucravacitinib (6 mg, once a day) compared with placebo and Otezla (apremilast, 30 mg, twice a day)Compared with Otezla, a higher proportion of patients reached PASI75 and sPGA 0/1 at week 24 and maintained until week 52
.
In this study, deucravacitinib was safe and well tolerated
.
April Armstrong, MD, professor of dermatology at the University of Southern California, said: "In these two key studies, deucravacitinib is superior to Otezla in multiple endpoints, including response durability and maintenance indicators
.
This shows that the need for systemic treatment , Need for a better oral option to treat patients with moderate to severe plaque psoriasis, deucravacitinib has the potential to become a new standard of oral care
.
Because many patients with moderate to severe plaque psoriasis still do not Get adequate treatment, or even no treatment, so it is also encouraging that deucravacitinib improves patient symptoms and prognosis to a greater extent than Otezla
.
"
.
This shows that the need for systemic treatment , Need for a better oral option to treat patients with moderate to severe plaque psoriasis, deucravacitinib has the potential to become a new standard of oral care
.
Because many patients with moderate to severe plaque psoriasis still do not Get adequate treatment, or even no treatment, so it is also encouraging that deucravacitinib improves patient symptoms and prognosis to a greater extent than Otezla
.
"
Mary Beth Harler, MD, Director of Immunology and Fibrosis Development at Bristol-Myers Squibb, said: “The results of both studies have confirmed that deucravacitinib has the potential to become an oral treatment option for patients with psoriasis
.
We believe that deucravacitinib is in a wide range of immune-mediated diseases.
With great potential, we are committed to advancing the extensive clinical development of deucravacitinib
.
Currently, we are discussing with regulatory agencies with the aim of bringing this new therapy to appropriate patients as soon as possible
.
"
.
We believe that deucravacitinib is in a wide range of immune-mediated diseases.
With great potential, we are committed to advancing the extensive clinical development of deucravacitinib
.
Currently, we are discussing with regulatory agencies with the aim of bringing this new therapy to appropriate patients as soon as possible
.
"
psoriasis
Otezla is an oral anti-inflammatory drug of Celgene , which was acquired by Amgen for US$13.
4 billion
in August 2019 .
In January 2019, Bristol-Myers Squibb (BMS) announced a $74 billion acquisition of Xinji .
As part of the US Federal Trade Commission (FTC) antitrust review , Otezla was forced to sell,
and Amgen later took over .
Otezla is an oral selective phosphodiesterase 4 (PDE4) small molecule inhibitor.
It has been approved for 3 indications (moderate to severe plaque psoriasis, active psoriatic arthritis, Behcet’s disease-related oral ulcers) )
.
At the time, Otezla was the only oral, non-biological therapy for psoriasis and psoriatic arthritis, and the only drug for treating Behcet’s disease-related oral ulcers
.
According to the 2020 performance report released by Amgen , Otezla has sales of US$2.
195 billion, making it the third best-selling drug for Amgen
.
Otezla, an oral anti-inflammatory drug of Celgene, was acquired by Amgen for $13. 4 billion
in August 2019 .
In January 2019, Bristol-Myers Squibb (BMS) announced a $74 billion acquisition of Xinji .
As part of the US Federal Trade Commission (FTC) antitrust review , Otezla was forced to sell,
and Amgen later took over .
Otezla is an oral selective phosphodiesterase 4 (PDE4) small molecule inhibitor.
It has been approved for 3 indications (moderate to severe plaque psoriasis, active psoriatic arthritis, Behcet’s disease-related oral ulcers) )
.
At the time, Otezla was the only oral, non-biological therapy for psoriasis and psoriatic arthritis, and the only drug for treating Behcet’s disease-related oral ulcers
.
According to the 2020 performance report released by Amgen , Otezla has sales of US$2.
195 billion, making it the third best-selling drug for Amgen
.
4 billion
.
Bristol-Myers Squibb (BMS) announced that it would acquire Xinji for US$74 billion.
Otezla was forced to sell under antitrust review , and Amgen took over
.
Otezla's sales of 2.
195 billion US dollars, is Amgen's third best-selling drug
Deucravacitinib is a new oral selective TYK2 inhibitor developed by Bristol-Myers Squibb.
It has a unique mechanism of action different from other kinase inhibitors
.
TYK2 is an intracellular signal kinase that mediates the signal transduction of IL-23, IL-12, and type I IFN.
These cytokines are natural cytokines involved in inflammation and immune response
.
The pharmaceutical market research organization EvaluatePharma released a report at the beginning of this year and predicted that deucravacitinib's sales in 2026 will reach $2.
21 billion
.
Sales of deucravacitinib in 2026 will reach US$2. It has a unique mechanism of action different from other kinase inhibitors
.
TYK2 is an intracellular signal kinase that mediates the signal transduction of IL-23, IL-12, and type I IFN.
These cytokines are natural cytokines involved in inflammation and immune response
.
The pharmaceutical market research organization EvaluatePharma released a report at the beginning of this year and predicted that deucravacitinib's sales in 2026 will reach $2.
21 billion
.
21 billion
.
Currently, deucravacitinib is being evaluated for the treatment of a wide range of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus, and inflammatory bowel disease
.
In addition to POETYK PSO-1 and POETYK PSO-2, Bristol-Myers Squibb is conducting three other phase 3 studies on deucravacitinib: POETYK PSO-3 (NCT04167462), POETYK PSO-4 (NCT03924427), POETYK PSO-LTE (NCT04036435 )
.
.
In addition to POETYK PSO-1 and POETYK PSO-2, Bristol-Myers Squibb is conducting three other phase 3 studies on deucravacitinib: POETYK PSO-3 (NCT04167462), POETYK PSO-4 (NCT03924427), POETYK PSO-LTE (NCT04036435 )
.
The chemical structure of deucravacitinib (picture source: genome.
jp)
jp)
POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are two global phase 3 studies conducted in patients with moderate to severe plaque psoriasis to evaluate the relative For the safety and effectiveness of placebo and Otezla (apremilast)
.
Both studies are multi-center, randomized, double-blind trials, enrolling 666 and 1,020 patients, respectively, and evaluated deucravacitinib (6 mg, once a day), placebo and Otezla (30 mg, twice a day)
.
The POETYK PSO-2 study also has a random withdrawal and retreatment period after 24 weeks
.
.
Both studies are multi-center, randomized, double-blind trials, enrolling 666 and 1,020 patients, respectively, and evaluated deucravacitinib (6 mg, once a day), placebo and Otezla (30 mg, twice a day)
.
The POETYK PSO-2 study also has a random withdrawal and retreatment period after 24 weeks
.
The common primary endpoint of the two studies is: at the 16th week of treatment, compared with the placebo group, the proportion of patients in the deucravacitinib treatment group reached PASI75 and sPGA 0/1
.
Key secondary endpoints include: at week 16, the proportion of patients who achieved PASI75 and sPGA 0/1 in the deucravacitinib treatment group compared with the Otezla treatment group, and other indicators
.
.
Key secondary endpoints include: at week 16, the proportion of patients who achieved PASI75 and sPGA 0/1 in the deucravacitinib treatment group compared with the Otezla treatment group, and other indicators
.
The results showed that both studies reached the common primary endpoint: at the 16th week of treatment, compared with the placebo group, a significantly higher proportion of patients in the deucravacitinib treatment group achieved PASI75 and sPGA 0/1
.
In the two studies, the key secondary endpoints were evaluated using PASI75 and sPGA 0/1 at the 16th and 24th weeks, and deucravacitinib showed better skin lesion clearance than Otezla
.
Deucravacitinib is well tolerated, and the discontinuation rate due to adverse events (AE) is low
.
.
In the two studies, the key secondary endpoints were evaluated using PASI75 and sPGA 0/1 at the 16th and 24th weeks, and deucravacitinib showed better skin lesion clearance than Otezla
.
Deucravacitinib is well tolerated, and the discontinuation rate due to adverse events (AE) is low
.
Deucravacitinib clinical data
The specific results are:
——PASI75 response rates in the POETYK PSO-1 and POETYK PSO-2 studies : (1) At week 16, 58.
7% and 53.
6% of patients in the deucravacitinib treatment group achieved PASI75 responses, respectively, and 12.
7% in the placebo group, respectively.
9.
4% and Otezla treatment group were 35.
1% and 40.
2% respectively
.
(2) At the 24th week, 69.
0% and 59.
3% of patients in the deucavacitinib treatment group achieved PASI75 responses, and 38.
1% and 37.
8% in the Otezla treatment group, respectively
.
(3) 82.
5% and 81.
4% of patients who received deucravacitinib treatment reached a PASI75 response at week 24 and continued to receive deucravacitinib treatment, respectively, maintained a PASI75 response at week 52
.
——PASI75 response rate in POETYK PSO-1 and POETYK PSO-2 studies7% and 53.
6% of patients in the deucravacitinib treatment group achieved PASI75 responses, respectively, and 12.
7% in the placebo group, respectively.
9.
4% and Otezla treatment group were 35.
1% and 40.
2% respectively
.
(2) At the 24th week, 69.
0% and 59.
3% of patients in the deucavacitinib treatment group achieved PASI75 responses, and 38.
1% and 37.
8% in the Otezla treatment group, respectively
.
(3) 82.
5% and 81.
4% of patients who received deucravacitinib treatment reached a PASI75 response at week 24 and continued to receive deucravacitinib treatment, respectively, maintained a PASI75 response at week 52
.
——The sPGA 0/1 response rate in the POETYK PSO-1 and POETYK PSO-2 studies : (1) At week 16, 53.
6% and 50.
3% of the deucravacitinib treatment group achieved sPGA 0/1 response, placebo Groups were 7.
2%, 8.
6%, Otezla treatment group were 32.
1%, 34.
3%
.
(2) At the 24th week, 58.
4% and 50.
4% of patients in the deucavacitinib treatment group achieved sPGA 0/1 response, respectively, and 31.
0% and 29.
5% in the Otezla treatment group, respectively
.
-SPGA 0/1 response rate in the POETYK PSO-1 and POETYK PSO-2 studies6% and 50.
3% of the deucravacitinib treatment group achieved sPGA 0/1 response, placebo Groups were 7.
2%, 8.
6%, Otezla treatment group were 32.
1%, 34.
3%
.
(2) At the 24th week, 58.
4% and 50.
4% of patients in the deucavacitinib treatment group achieved sPGA 0/1 response, respectively, and 31.
0% and 29.
5% in the Otezla treatment group, respectively
.
-Deucravacitinib shows strong efficacy compared with placebo and Otezla : including superiority to placebo in the common primary endpoint, and superior to Otezla in the key secondary endpoint
.
In addition to the PASI75 and sPGA 0/1 indicators, deucravacitinib was superior to Otezla in multiple secondary endpoints of the two studies, indicating a significant and clinically significant improvement in the symptoms of burden of symptoms and quality of life indicators
.
——Deucravacitinib shows strong efficacy compared with placebo and Otezla.
In addition to the PASI75 and sPGA 0/1 indicators, deucravacitinib was superior to Otezla in multiple secondary endpoints of the two studies, indicating a significant and clinically significant improvement in the symptoms of burden of symptoms and quality of life indicators
.
——Safety and tolerability : In 2 studies, deucravacitinib is safe and well tolerated
.
After 16 weeks of treatment, 2.
9% of the placebo group (n=419), 1.
8% of the deucravacitinib group (n=842), and 1.
2% of the Otezla group (n=422) experienced serious adverse events (SAE), respectively 3.
8%, 2.
4% and 5.
2% of patients experienced adverse events (AE) leading to discontinuation
.
After 52 weeks of treatment, the adjusted SAE (incidence per 100 patient-years after exposure adjustment [EAIR]) was 5.
7 in the placebo group, 5.
7 in the deucravacitinib group, and 4.
0 in the Otezla group
.
During the same time period of the two studies, the EAIR that caused the discontinuation of the drug was 9.
4 in the placebo group, 4.
4 in the deucravacitinib group, and 11.
6 in the Otezla group
.
No new safety signals were observed in weeks 16-52
.
Two studies, malignant tumors , major adverse cardiovascular events (MACE), lower venous thromboembolism (VTE) and the incidence of serious infections, and basically the same in the active treatment group
.
Within 52 weeks, no clinically significant changes were observed in a number of laboratory indicators (including anemia , blood cells, blood lipids and liver enzymes)
.
()
——Safety and tolerable tumor anemia.
After 16 weeks of treatment, 2.
9% of the placebo group (n=419), 1.
8% of the deucravacitinib group (n=842), and 1.
2% of the Otezla group (n=422) experienced serious adverse events (SAE), respectively 3.
8%, 2.
4% and 5.
2% of patients experienced adverse events (AE) leading to discontinuation
.
After 52 weeks of treatment, the adjusted SAE (incidence per 100 patient-years after exposure adjustment [EAIR]) was 5.
7 in the placebo group, 5.
7 in the deucravacitinib group, and 4.
0 in the Otezla group
.
During the same time period of the two studies, the EAIR that caused the discontinuation of the drug was 9.
4 in the placebo group, 4.
4 in the deucravacitinib group, and 11.
6 in the Otezla group
.
No new safety signals were observed in weeks 16-52
.
Two studies, malignant tumors , major adverse cardiovascular events (MACE), lower venous thromboembolism (VTE) and the incidence of serious infections, and basically the same in the active treatment group
.
Within 52 weeks, no clinically significant changes were observed in a number of laboratory indicators (including anemia , blood cells, blood lipids and liver enzymes)
.
()
Original source: Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla? (apremilast)
