Delving into the Latest Updates on Deucravacitinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Deucravacitinib (USAN), BMS-986165, BMS-986165-01

+ [3]

Target

TYK2

Mechanism

TYK2 inhibitors(Tyrosine-protein kinase 2 inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesInfectious Diseases+ [4]

Active Indication

Erythrodermic psoriasisPsoriasis vulgarisPustular psoriasis+ [12]

Inactive Indication

Gilbert DiseaseKidney Failure, ChronicLupus Nephritis

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

Mayo ClinicBristol-Myers Squibb Pharma EEIG

+ [4]

Inactive Organization

Bristol-Myers Squibb (China) Investment Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

US (09 Sep 2022),

Plaque psoriasis

RegulationSpecial Review Project (CN)

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Structure

Molecular FormulaC20H22N8O3

InChIKeyBZZKEPGENYLQSC-FIBGUPNXSA-N

CAS Registry1609392-27-9

The purpose of this study is to evaluate the safety and effectiveness of Deucravacitinib (BMS-986165) in Pityriasis Rubra Pilaris as assessed by the change in Investigator Global Assessment (IGA), PASI- 50, 75, 90, DLQI, NRS itch, and Skindex-16 at week 24. To predict responses through the identification of unique biomarkers of PRP utilizing single-cell RNA sequencing.

Start Date01 Jul 2024

Sponsor / Collaborator

Mayo Clinic

NCT06258668 / Not yet recruitingNot Applicable

Sotyktu (Deucravacitinib) Post-Marketing Surveillance in Korean Patients With Moderate-to-Severe Plaque Psoriasis

The purpose of this observational study is to describe the safety and effectiveness of deucravacitinib in participants in Korea that have been diagnosed with moderate-to-severe plaque psoriasis.

Start Date01 Jul 2024

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Deucravacitinib

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100 Translational Medicine associated with Deucravacitinib

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100 Patents (Medical) associated with Deucravacitinib

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98

Literatures (Medical) associated with Deucravacitinib

31 Dec 2024·The Journal of dermatological treatment

Effectiveness and safety of deucravacitinib treatment for moderate-to-severe psoriasis in real-world clinical practice in Japan

Article

Author: Hagino, Teppei ; Fujimoto, Eita ; Saeki, Hidehisa ; Kanda, Naoko

BACKGROUND:

Deucravacitinib is a selective oral tyrosine kinase 2 (TYK2) inhibitor recently approved for psoriasis.

OBJECTIVES:

We aimed to evaluate the real-world effectiveness and safety of deucravacitinib for psoriasis.

METHODS:

We analyzed 33 Japanese patients with psoriasis (23 with plaque psoriasis, eight with psoriatic arthritis, and two with erythrodermic psoriasis) from January 2023 to October 2023. All patients received deucravacitinib 6 mg daily until week 16.

RESULTS:

At week 8, 12, or 16, the achievement rate of PASI 75 was 60.9%, 73.9%, or 78.3%, that of PASI 90 was 13.0%, 39.1%, or 52.2%, that of PASI 100 was 0%, 8.7%, or 13.0%, that of absolute PASI ≤2 was 34.8%, 65.2%, or 78.3%, respectively. The achievement rate of dermatology life quality index 0/1 at week 16 was 42.9%. Fourteen patients (42%) complained pruritus. Peak pruritus-numerical rating scale in patients with pruritus decreased by median [interquartile] 71.4 [50-80] % of baseline at week 2. Adverse events occurred in 18.2% of patients, which were mild and manageable.

CONCLUSIONS:

Deucravacitinib for patients with psoriasis was well-tolerated and gave favorable therapeutic effects in the real-world practice. Deucravacitinib treatment rapidly reduced pruritus.

01 May 2024·Current opinion in rheumatology

Emerging biologic therapies for systemic lupus erythematosus

Review

Author: Kato, Hiroshi ; Kahlenberg, J. Michelle

Purpose of review:

The approval of belimumab and anifrolumab has expanded the scope of treatment for systemic lupus erythematosus (SLE) patients. However, many patients remain refractory to currently available therapies and suffer from drug toxicities. This review will discuss approved and target-specific therapeutics in development that bring hope for better SLE treatments.

Recent findings:

Since the last review on this subject in the journal, the FDA has approved anifrolumab and belimumab for SLE and lupus nephritis (LN), respectively. A fully humanized anti-CD20, obinutuzumab, met the primary end point in a phase II trial in LN. A Tyk2 inhibitor, deucravacitinib, and an antibody targeting plasmacytoid dendritic cells, litifilimab, met the primary end point in phase II trials in SLE and cutaneous lupus erythematosus (CLE). Ustekinumab and baricitinib met the primary end point in phase II but not in phase III trials.

Summary:

While many drug candidates which met the end points in phase II trials have failed phase III trials, the number of target-specific therapies for SLE has continued to expand.

01 Feb 2024·Journal of drugs in dermatology : JDD

Deucravacitinib for Moderate-to-Severe Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Review

Author: de Carvalho, Caio C ; Toth, Otavio A S ; Kracik, Jose L S ; Machado, Pablo G ; Mease, Philip J ; Guzatti, Joao V L ; Meldola, Patrick F ; Schnorrenberger, Erick ; Chiarelli, Gabriel F C

There is contrasting evidence regarding the efficacy and safety of JAK (Janus kinase) inhibitors in the treatment of psoriasis. This systematic review and meta-analysis assessed deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, as the therapy of choice for moderate-to-severe psoriasis. PubMed, Embase, and Cochrane databases were searched for randomized controlled trials, including patients with moderate-to-severe psoriasis. Outcomes of interest were serious adverse events (SAEs), the severity of illness, as measured by the validated questionnaires: Psoriasis Area and Severity Index (PASI) and scalp-specific Physician's Global Assessment (ss-PGA); and quality of life, measured by the Dermatology Life Quality Index (DLQI). Four studies with 1663 patients were included in the meta-analysis, of whom 1123 (67.5%) were treated with deucravacitinib during a 12-to-16-week follow-up. The mean age was 45.4 ± 13.3 years, and 70.2% were male. Two-thirds had a history of scalp psoriasis. Achievement of PASI 75 was significantly higher in the deucravacitinib group, as compared with placebo (RR 5.7; 95% CI 4.32-7.53; P<0.001). Similarly, ss-PGA 0/1 (RR 3.86; 95%CI 3.02-4.94; P<0.001) and DLQI 0/1 (RR 3.89; 2.89-5.22; P<0.001) were also significantly more frequent in the deucravacitinib group. The incidence of SAEs was similar between groups. These findings suggest that patients with moderate-to-severe psoriasis treated with deucravacitinib for 12 to 16 weeks had significantly decreased severity of illness and improved quality of life, without a concerning increase in the incidence of SAEs. J Drugs Dermatol. 2024;23(2):67-73. doi:10.36849/JDD.7539.

137

News (Medical) associated with Deucravacitinib

14 Jun 2024

·www.fiercepharma.com

Fierce Pharma Asia—AbbVie's TL1A deal; Ex-Takeda staffer's guilty plea; Kyowa Kirin's $530M plant investment

AbbVie's TL1A deal with FutureGen Biopharma, an ex-Takeda staffer's scam scheme and Kyowa Kirin's hefty investment in North Carolina made our news this week. Through a licensing deal with a Chinese biotech, AbbVie is the latest Big Pharma to bet on TL1A in immunology. A former Takeda employee has pleaded guilty to scamming the Japanese drugmaker through a fake consulting firm. Kyowa Kirin will invest up to $530 million in a biologics plant in North Carolina. And more. 1. AbbVie joins TL1A race via $150M upfront deal with China's FutureGen AbbVie is paying $150 million upfront for a preclinical inflammatory bowel disease candidate from China’s FutureGen Biopharmaceutical, with $1.56 billion in potential milestones. The drug targets TL1A, the same focus of Roche’s $7 billion acquisition of Telavant and Merck’s $11 billion takeover of Prometheus Biosciences last year. AbbVie believes its asset is different from first-generation antibodies. 2. Ex-staffer pleads guilty to scamming Takeda out of $2.3M through fake consulting firm A former senior level employee at Takeda has pleaded guilty to charges around how she and a co-conspirator allegedly defrauded the drugmaker into paying $2.3 million for fake consulting work. The scheme began in 2022, when the ex-staffer incorporated the sham consulting practice. The two allegedly used the money to buy a diamond ring, a condo and a Mercedes-Benz and to make a down payment on a wedding venue. 3. Kyowa Kirin to expand manufacturing footprint with $530M biologics plant in North Carolina Kyowa Kirin is pouring up to $530 million into building a 171,700-square-foot biologics facility in Sanford, North Carolina, as the Japanese company’s first manufacturing site in North Amerca. The size of the investment was significantly larger than the previously announced $200 million. The site is expected to create more than 100 jobs and is expected to be fully operational by 2027. 4. WuXi shares jump after BIOSECURE Act's exclusion from defense spending bill WuXi AppTec and WuXi Biologics got a temporary reprieve as uncertainty grows around the BIOSECURE Act’s legislative path. The bill was denied consideration in the annual National Defense Authorization Act, which determines the Department of Defense’s budget each year. Rep. Brad Wenstrup, the lead GOP sponsor of the bipartisan bill, told Axios that he would seek other routes to move the bill forward. 5. Would BIO support a biosecurity bill targeting drug developers? Hear CEO John Crowley’s response Meanwhile, the Biotechnology Innovation Organization’s CEO John Crowley said he has expressed to Congress that any potential new targets under the BIOSEUCRE Act must be based on “very clear and convincing evidence.” A recent request for an intelligence briefing on GenScript and its related businesses raised the faintest possibility of a potential expansion of the bill. However, Kevin Noonan, Ph.D., from law firm MBHB argued that the bill wouldn’t target drug developers. 6. Analysts tip Lilly's Alzheimer's launch to boost rival Leqembi Eli Lilly tipped to leapfrog Eisai, Biogen and take control of $13B Alzheimer's market As Eli Lilly’s donanemab sailed through an FDA advisory committee meeting, Bloomberg Intelligence analysts figured the drug could beat Eisai and Biogen’s Leqembi on sales in 12 months after a potential approval in part because of its more convenient dosing and the ability to stop treatment. Nevertheless, William Blair analysts viewed donanemab’s potential approval as an opportunity to boost the overall Alzheimer’s disease market for anti-amyloid drugs. 7. Alumis sets out IPO ambitions to fund TYK2 inhibitor through phase 3 psoriasis trials Alumis is looking for an IPO to accelerate the development of its immunology pipeline. The company’s lead asset, a TYK2 inhibitor coded ESK-001, was in-licensed from China’s Haisco Pharma back in 2021 for up to $180 million in upfront and potential milestone payments. The California biotech now aims to advance the drug—a potential competitor to Bristol Myers Squibb’s Sotyktu—into phase 3 trials in plaque psoriasis later this year. Other News of Note: 8. European antitrust watchdog accuses API manufacturer Alchem of engaging in price-fixing scheme 9. FDA accepts Eisai's monthly dosing application for Leqembi, sets Jan. 25 decision date 10. Lotus Pharma picks up Teva's Thailand operations for undisclosed sum 11. Junshi, Coherus' PD-1 inhibitor Loqtorzi scores in phase 3 liver cancer trial 12. Takeda extends Partners in Health collab to improve access to care in Massachusetts

Phase 3AcquisitionLicense out/in

10 Jun 2024

·www.fiercebiotech.com

Alumis sets out IPO ambitions to fund TYK2 inhibitor through phase 3 psoriasis trials

Back in March, Alumis CEO Martin Babler told Fierce that an IPO was one of many options to consider for the future. Not content with bringing in one of the largest private biotech fundraises of 2024 so far, Alumis has now become the latest drug developer to set its sights on the public markets. The California-based company has yet to disclose how many shares will be sold or at what price but said in a June 7 Securities and Exchange Commission filing that proceeds would be used to accelerate a pipeline of oral therapies designed to tackle immune dysfunction. Specifically, Alumis plans to use part of the IPO haul to advance the development of its lead asset, an allosteric tyrosine kinase 2 (TYK2) inhibitor called ESK-001, into multiple phase 3 trials in moderate to severe plaque psoriasis later this year. Alumis will also complete ongoing phase 2 trials in a type of eye inflammation called uveitis as well as in systemic lupus erythematosus. Some of the money will be used to push ahead with a phase 1 trial of another allosteric TYK2 inhibitor, dubbed A-005, in healthy volunteers, the company explained in the filing. A-005 is being lined up as a possible treatment for neuroinflammatory and neurodegenerative diseases. The announcement of IPO ambitions comes just three months after Alumis brought in a $259 million series C financing that saw Lilly Asia Ventures join a list of investors headed up by Foresite Capital, Samsara BioCapital and venBio Partners. It was the largest private biotech fundraise of the year at that point, although it was soon overtaken by Mirador Therapeutics’ $400 million series A. At the time, Alumis President and CEO Martin Babler told Fierce Biotech that the fundraise reflected investors’ confidence in the biotech’s team, assets, strategy and technology. “I think that we're fortunate that we are actually more advanced with our molecule,” Babler added in the same March interview. “That has helped—companies that have proof-of-concept and are more advanced are probably having it a little bit easier to raise money today.” Babler didn’t discount the possibility of an IPO down the line, only telling Fierce at the time that it was one of many options to consider for the future. A couple of days after the financing, Alumis’ confidence in ESK-001—which Babler had described as an “extremely well-behaved molecule”—was affirmed when the drug met its primary endpoint of improving psoriasis in a phase 2 study. When set against data for Bristol Myers Squibb’s approved plaque psoriasis therapy Sotyktu, Alumis said at the time that ESK-001 had demonstrated “potential to be a best in class oral TYK2 inhibitor.” Alumis’ IPO announcement Friday is the latest in a trickle of summer biotech offerings. Third Rock’s Rapport Therapeutics went public on the same day with an upsized $154 million offering, capping off a week that also saw Australia-listed Telix Pharmaceuticals set out plans to bring in over $200 million via a Nasdaq debut. The string of announcements back up the predictions of Medicxi Partner Francesco De Rubertis, Ph. D., who told Fierce last month that he expected the biotech IPO window to reopen this summer.

Phase 2IPOPhase 1Phase 3Clinical Result

10 Jun 2024

·firstwordpharma.com

With $600M in private funding, Alumis gears up to go public

On the heels of a $259-million March megaround, inflammation-focused Alumis is now gunning to pivot its private success – having garnered more than $600 million in total funding – in the public markets. The biotech joined the IPO queue on Monday and also shared updated timelines for its two clinical candidates, which are in development for several autoimmune and neurodegenerative diseases.Alumis’ lead compound is ESK-001, an oral TYK2 inhibitor that the company is setting up to compete with Bristol Myers Squibb’s Sotyktu (deucravacitinib) in the oral psoriasis treatment space. For more, see KOL Views Q&A: Leading dermatologist lays out decision tree for psoriasis treatments.In March, Alumis shared 12-week, Phase II data for the experimental treatment at the American Academy of Dermatology (AAD) annual meeting showing that, among moderate-to-severe plaque psoriasis patients treated with 40mg of ESK-001 twice-daily, 64.1% achieved PASI-75, 38.5% achieved PASI-90, and 15.4% achieved PASI-100. The benefit improved further over time, as an ongoing label-extension study demonstrated. At 16 weeks, 90% of patients reached PASI-75, 57% saw PASI-90, and 35% achieved PASI-100, comparing favourably to the Phase III data on Sotyktu’s label.Alumis plans to start a Phase III trial next half of ESK-001 in patients with moderate-to-severe plaque psoriasis. Beyond psoriasisThe company is also evaluating ESK-001 in two separate, ongoing Phase II trials. The OPTYK-1 proof-of-concept trial in non-infectious uveitis is expected to report topline data by year-end, and the LUMUS study in systemic lupus erythematosus will read out in 2026.Alumis’ portfolio also includes A-005, a brain-penetrant compound in development for neuro-inflammatory diseases such as multiple sclerosis (MS). Data from a Phase I trial in healthy volunteers are due by year-end. According to Alumis, genetic data have shown that “naturally occurring TYK2 loss-of-function genetic variant has a protective effect in MS." The company said it has also demonstrated that protective effect in in vivo models of neuroinflammation.

Phase 2Clinical Result

100 Deals associated with Deucravacitinib

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External Link

KEGG	Wiki	ATC	Drug Bank
D11817	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Erythrodermic psoriasis	JP	Bristol-Myers Squibb KK	26 Sep 2022
Psoriasis vulgaris	JP	Bristol-Myers Squibb KK	26 Sep 2022
Pustular psoriasis	JP	Bristol-Myers Squibb KK	26 Sep 2022
Plaque psoriasis	US	Bristol Myers Squibb Co.	09 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sjogren's Syndrome	Phase 3	US	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	JP	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	AR	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	AU	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	AT	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	BE	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	BR	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	BG	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	CA	Bristol Myers Squibb Co.	11 Sep 2023
Sjogren's Syndrome	Phase 3	CL	Bristol Myers Squibb Co.	11 Sep 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04036435 (POETYK PSO-LTE, Company_Website) Manual	Phase 3	Plaque psoriasis	1,221	Sotyktu (deucravacitinib) 6 mg	uvehialjai(vibrgvgtsl) = yxerzewrws exjualnoxx (fxgghesyeg ) View more	Positive	16 May 2024
NCT04036435 (POETYK PSO-1 and PSO-2, Pubmed)	Phase 3	Plaque psoriasis	1,519	Deucravacitinib 6 mg	kumnaprpht(lnmpsuvvkt) = EAIRs for COVID-19 infections were higher at 2 years than at 1 year (5.1 vs 0.5) due to the peak of the global COVID-19 pandemic occurring during the LTE ftodisdgrj (jlrjxrfyuk )	Positive	16 Jan 2024
ACR2023	Phase 2	Systemic Lupus Erythematosus antinuclear antibody \| anti-double-stranded DNA \| anti-Smith antibody	363	Deucravacitinib 3 mg BID	woeajvrscx(sfzqxtbmit) = edlviigipa bgaeubyeqm (xvrcstasvn, 12.6) View more	Positive	14 Nov 2023
ACR2023	Phase 2		363	Deucravacitinib 6 mg BID	woeajvrscx(sfzqxtbmit) = jlzissklks bgaeubyeqm (xvrcstasvn, 13.1) View more	Positive	14 Nov 2023
NCT04036435 (POETYK LTE, ACR2023)	Phase 3	Plaque psoriasis Maintenance	513	Deucravacitinib 6 mg QD	xzdsjglmoz(jwlaxuassx) = zxfynffqrz shgoakcgps (nosxuivrzh, 57.0 - 65.6) View more	Positive	13 Nov 2023
NCT03252587 (Phase 2 Trial in Systemic Lupus Erythematosus (SLE), ACR2023)	Phase 2	Systemic Lupus Erythematosus	363	Deucravacitinib 3 mg BID	mgbaqewgmj(ubackdbyaa) = hataalevht jhfxjfdpjt (ztsoswrehg )	Positive	12 Nov 2023
	Phase 2	Systemic Lupus Erythematosus	363	Deucravacitinib 6 mg BID	mgbaqewgmj(ubackdbyaa) = oxolxdjots jhfxjfdpjt (ztsoswrehg )	Positive	12 Nov 2023
NCT04036435 (POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751), ACR2023)	Phase 3	Plaque psoriasis	1,519	Deucravacitinib 6 mg once daily	iqfozlwgdh(phjuyolyfs) = dpdjxkjakr vmrshkhulz (djmluesxbm, 68.7 - 77.8) View more	Positive	12 Nov 2023
NCT03624127 \| NCT03611751 ( POETYK PSO-2, EADV2023) Manual	Phase 3	Plaque psoriasis	1,519	deucravacitinib	cfjorkwoqm(jjewpwdjbz) = kcphwkvyps ncczzvwwdh (boqoazaqai, 56.6 - 65.6) View more	Positive	12 Oct 2023
NCT04036435 (POETYK PSO, NEWS) Manual	Phase 3	Plaque psoriasis	-	Sotyktu (deucravacitinib)	sritwxlndu(odbkcqsnep) = vudmnefbyk otcagsbrvd (eprctxrhqz ) View more	Positive	11 Oct 2023
POETYK PSO-1 (EADV2023)	Not Applicable	Plaque psoriasis	-	Deucravacitinib	heyvbwpkzj(unjlvmfars) = kldlpmjkno gcbyhtmgsz (xklzflmntp ) View more	-	11 Oct 2023
POETYK PSO-1 (EADV2023)	Not Applicable	Plaque psoriasis	-	Apremilast	heyvbwpkzj(unjlvmfars) = trvizdbbmw gcbyhtmgsz (xklzflmntp ) View more	-	11 Oct 2023
NCT04167462 (POETYK PSO-3, EADV2023)	Phase 3	Plaque psoriasis	-	Deucravacitinib 6 mg once daily	ddhbmydxgq(lkgntypvvm) = kjvfdzswgy nfoifdqjss (oeuyyluwiy )	Positive	11 Oct 2023
NCT04167462 (POETYK PSO-3, EADV2023)	Phase 3	Plaque psoriasis	-	Placebo	ddhbmydxgq(lkgntypvvm) = ctuybfazki nfoifdqjss (oeuyyluwiy )	Positive	11 Oct 2023