Explore the efficacy and safety of targeted small molecule drug TYK2 inhibitors in combination with and without calcipotriol betamethasone for the treatment of adult moderate to severe plaque psoriasis.

Start Date01 Nov 2024

Sponsor / Collaborator-

CTR20223222

/ CompletedPhase 3

一项在中国稳定性斑块状银屑病成人受试者中比较LEO 90100和得肤宝 ®软膏治疗4周的有效性和安全性的III期、随机、研究者设盲、活性药物对照、平行分组、多中心试验

[Translation] A Phase III, randomized, investigator-blinded, active-controlled, parallel-group, multicenter trial comparing the efficacy and safety of LEO 90100 and Depo-Perot® Ointment for 4 weeks in Chinese adult subjects with stable plaque psoriasis

主要目的：评价LEO 90100与得肤宝®软膏相比对稳定性斑块状银屑病严重程度和范围的有效性。次要目的：评价LEO 90100与得肤宝®软膏相比治疗稳定性斑块状银屑病的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of LEO 90100 compared with Defubain® Ointment on the severity and extent of stable plaque psoriasis. Secondary objective: To evaluate the safety of LEO 90100 compared with Defubain® Ointment in the treatment of stable plaque psoriasis.

Start Date21 Jun 2023

Sponsor / Collaborator

LEO Laboratories Ltd.

[+2]

NCT05919082

/ CompletedPhase 3

A Phase 3, Randomised, Investigator-blind, Active-controlled, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet® Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis

This study is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects, compared to Daivobet® ointment.

Start Date21 Jun 2023

Sponsor / Collaborator

Leo Pharma, Inc.

100 Clinical Results associated with Betamethasone Dipropionate/Calcipotriene

100 Translational Medicine associated with Betamethasone Dipropionate/Calcipotriene

100 Patents (Medical) associated with Betamethasone Dipropionate/Calcipotriene

Literatures (Medical) associated with Betamethasone Dipropionate/Calcipotriene

01 Mar 2024·Dermatology and therapy

Improvements in Plaque Psoriasis Associated with Calcipotriol/Betamethasone Aerosol Foam Treatment: A Post Hoc Analysis of Non-interventional Studies and Clinical Experience

Article

Author: Jablonski Bernasconi, Marie Y ; Halioua, Bruno ; Lazaridou, Elizabeth ; Krogager Eeg, Martin ; Pesiridis, Georgios ; Campanati, Anna ; Ratzinger, Gudrun ; Gerdes, Sascha

INTRODUCTION:

Plaque psoriasis is a chronic relapsing inflammatory skin disease that is associated with extensive disease burden that often requires long-term therapy. Treatment of psoriasis with 4 weeks of the aerosol foam formulation of calcipotriol/betamethasone dipropionate (Cal/BD; Enstilar®, LEO Pharma) has been demonstrated to be effective, well tolerated, and associated with high patient satisfaction. Cal/BD foam is approved as a first-line treatment in multiple countries, where several non-interventional studies (NIS) have corroborated the beneficial efficacy and safety profiles determined in the randomized clinical trials. Heterogenicity in these NIS, however, prevents the use of a data pooling strategy for comparisons of effectiveness outcomes across different patient populations.

METHODS:

Therefore, here, we report on a post hoc analysis of effectiveness data consolidated from six prospective NIS to discern any differences in improvement in signs and symptoms of psoriasis attributable to Cal/BD foam treatment across the countries. In addition, we provide real-world experience of clinicians with Cal/BD foam treatment, factoring in changes in usage since these NIS were performed in their local markets.

RESULTS:

This post hoc analysis of Cal/BD foam NIS brings together data outside of randomized clinical trials from six countries to provide real-world evidence in 1388 patients showing that 4 weeks of Cal/BD foam is an effective and safe treatment option with quick onset of action for patients with psoriasis.

CONCLUSION:

These results show that regardless of NIS location, Cal/BD foam remains a well-tolerated, efficacious option for patient care that could be used as a first-line topical therapy for mild-to-severe psoriasis.

31 Dec 2023·The Journal of dermatological treatment

Potential biomarkers for psoriasis topical treatment by in-depth serum proteomics

Article

Author: Yu, Xiaobo ; Deng, Hao ; Zhang, Xiaomei ; Yu, Jingjie ; Lu, Chuanjian ; Yao, Danni ; Deng, Jingwen ; Cui, Jingwen ; Ye, Shuyan ; Yan, Yuhong ; Han, Ling

BACKGROUND:

Psoriasis is a chronic skin disease, and topical sequential therapy with a combination of calcipotriol and calcipotriol betamethasone is currently approved topical treatment. However, the exact mechanism by which this treatment regimen relieves psoriasis is unknown.

METHOD:

We assembled a cohort of 65 psoriasis patients and divided post-treatment cohort into responder group and non-responder group according to the Psoriasis Area Severity Index (PASI) score after 12-week treatment. We measured the expression levels of proteins in collected 130 serum samples using our in-depth proteomics platform with a data-independent acquisition mass spectrometer and antibody microarray. We performed bioinformatics analyses of the biologic processes and signaling pathways that were changed in the responder group and constructed a proteomics landscape of psoriasis pathogenesis response to treatment. We then validated the biomarkers of disease severity in an independent cohort of 88 samples using an enzyme-linked immunosorbent assay.

RESULTS:

We first identified 174 differentially expressed proteins (DEPs) for comparative analysis of proteins between responders and non-responders at baseline (p < 0.05). Then pathway analysis showed that the responders focused more on signaling molecules and interaction, complement and coagulation cascades, whereas the non-responders more on signal transduction and IL-17 signaling pathways. We further identified four candidate biomarkers (COLEC11, C1QA, BNC2, ITIH4) response to treatment. We also found 125 DEPs (p < 0.05) after treatment compared with before treatment in responder group. Pathway analysis showed an enrichment in pathways related to complement and coagulation cascades, phagosome, ECM-receptor interaction, cholesterol metabolism, vitamin digestion and absorption. CD14 was validated as potential biomarkers for the disease severity of psoriasis and treatment targets.

CONCLUSION:

In this work, we analyzed the response to topical sequential therapy and finally identified four biomarkers. Additionally, we found that topical sequential therapy may alleviate psoriasis by regulating lipid metabolism and modulating the immune response by affecting the complement activation process.

01 Nov 2023·European review for medical and pharmacological sciences

The role of the foam formulation in improving psoriasis treatment acceptability: a real-life experience and a literature review.

Review

Author: Papa, S ; Gasparini, S ; Martella, A ; Giovene, G L

BACKGROUND:

Topical therapies represent the first-line treatment for mild-to-moderate psoriasis. Among various topical options, the fixed-dose combination of calcipotriene (Cal) and betamethasone dipropionate (BD) foam (Enstilar®, LEO Pharma, Ballerup, Denmark) showed superior efficacy to Cal and BD monotherapy and ointment and gel formulations. In addition, the Cal/BD foam is the only topical treatment allowed for either reactive treatment of relapse or twice-weekly maintenance use. Since treatment acceptability is crucial to optimize adherence, this paper presents a case series from a multicenter experience using the Cal/BD foam, to further characterize the use of this therapeutic approach. In addition, a narrative review of studies evaluating the acceptability of the Cal/BD foam, even compared with other formulations, is provided.

CASE SERIES:

The case series involved adult patients with mild-to-moderate psoriasis treated with the Cal/BD foam from October 2021 to June 2022. A clinical and dermoscopic evaluation of plaques was provided for all patients. Data from the clinical practice report complete clinical resolution of plaques in most patients after 4 weeks of active treatment with the Cal/BD foam, and the dermoscopic clearance after a maximum of 8 weeks. Full adherence to treatment was also reported. Literature evidence suggests that the Cal/BD foam is easy to apply and presents high cosmetic acceptance, rapid onset of action, high efficacy, optimal safety, and a high patient preference. The high satisfaction obtained with Cal/BD foam suggests that this formulation is better accepted than others.

CONCLUSIONS:

The Cal/BD foam represents a valuable approach for managing mild-to-moderate psoriasis, both in short and long-term treatment.

News (Medical) associated with Betamethasone Dipropionate/Calcipotriene

15 Nov 2024

·www.prnewswire.com

Endo Announces Agreement for Paladin Pharma to Commercialize Wynzora® Cream in Canada

MALVERN, Pa., Nov. 15, 2024 /PRNewswire/ -- Endo, Inc. (OTCQX: NDOI) announced today that it has entered into a definitive agreement with MC2 Therapeutics ("MC2") to commercialize Wynzora® Cream (calcipotriene and betamethasone dipropionate) in Canada through Endo's subsidiary Paladin Pharma Inc. "We look forward to working with MC2 to make Wynzora® Cream available to Canadians who suffer from plaque psoriasis," said Livio Di Francesco, Vice President and General Manager of Paladin. "If approved by Health Canada, Wynzora® Cream's unique formulation and clinical profile will offer patients a new treatment option designed for convenience of use in daily routines." "Paladin has an experienced and dedicated team, and we're pleased to work with them to introduce Wynzora® Cream in Canada," said Jesper J. Lange, Chief Executive Officer, MC2 Therapeutics. "The agreement aligns with our strategy to make Wynzora® Cream available to as many patients suffering from plaque psoriasis as possible globally." Wynzora® Cream was approved in the US by the FDA on July 20, 2020 and launched in Europe on February 18, 2022. About Wynzora® Cream Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis, including scalp psoriasis, in adults. Its dual mode of action is targeting the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF-α expression in a single product. Wynzora® Cream is uniquely enabled by MC2's formulation and drug delivery system PAD Technology™, allowing a convenient-to-use aqueous formulation. About Endo and Paladin Pharma Endo is a diversified specialty pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Paladin Pharma Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing, medical and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo, Inc. For more information, visit . About MC2 Therapeutics () MC2 Therapeutics is a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation. Its pioneering approach in immunology is anchored in a deep understanding of skin biology, clinical expertise and cross-silo thinking. Besides Wynzora® Cream, MC2 has a pipeline that includes two first-in-class drug candidates, both in Phase 2 clinical development. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Messrs. Di Francesco and Lange and any statements relating to product development and commercialization, treatment options and therapies, regulatory approval, efficacy and product availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, unfavorable or delayed regulatory review, uncertainties in and the timing for regulatory approval, changes in competitive, market or regulatory conditions, and consumer and physician acceptance of current and new products. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in Endo's press releases and in its public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/inPhase 2

14 Nov 2024

·mc2therapeutics.com

MC2 Therapeutics Announces License and Commercialization Agreement for Wynzora® Cream in Canada

Copenhagen, November 14, 2024 – MC2 Therapeutics, a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation, announces today an agreement with Endo, Inc. (OTCQX: NDOI), through its subsidiary Paladin Pharma Inc., under which they have been granted exclusive rights to commercialize MC2’s Wynzora® Cream for the treatment of plaque psoriasis for adults in Canada. MC2 Therapeutics will receive upfront and milestone payments as well as royalties on the Canadian net sales of Wynzora® Cream. “Paladin is acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With its ambition and strategy to grow its dermatology franchise it is an excellent partner for MC2 to leverage Wynzora® in Canada” said Jesper J. Lange, Chief Executive Officer of MC2 Therapeutics. “This deal substantiates our strategy to make Wynzora® available to as many patients suffering from plaque psoriasis as possible globally, as we continue to develop and expand our pipeline of innovative first-in-class drug candidates within immunology and inflammation.” “We look forward to working with MC2 to make Wynzora® Cream available to Canadians who suffer from plaque psoriasis,” said Livio Di Francesco, Vice President and General Manager of Paladin. “If approved by Health Canada, Wynzora® Cream’s unique formulation and clinical profile will offer patients a new treatment option designed for convenience of use in daily routines.” About Wynzora® Cream Wynzora® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis, including scalp psoriasis, in adults. Its dual mode of action is targeting the hallmark cytokines IL-23 and IL-17A/F immune axis and TNF-α expression in a single product. Wynzora® Cream is uniquely enabled by MC2’s formulation and drug delivery system PAD Technology™, allowing an effective convenient-to-use aqueous formulation. Wynzora® Cream was approved in the US by the FDA on July 20th, 2020, and in the first country in Europe on July 9th, 2021. About MC2 Therapeutics A/S MC2 Therapeutics is a commercial stage biotech company focused on developing novel treatment paradigms within immunology and inflammation. Its pioneering approach in immunology is anchored in a deep understanding of skin biology, clinical expertise and cross-silo thinking. Its pipeline includes two first-in-class drug candidates both in Phase 2 clinical development, with novel modes of action and potential in multiple indications (“I&I pipeline in a product”). For additional information on MC2 Therapeutics, please visit https://www.mc2therapeutics.com Contact: Lonni Goltermann, +45 2018 1111, investor@mc2therapeutics.com About Paladin Pharma Inc. Paladin Pharma Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing, medical and sales organization that has helped it evolve into one of Canada’s leading specialty pharmaceutical companies. Paladin is an operating company of Endo, Inc. For additional information, please visit https://www.paladin-pharma.com BACK

License out/inDrug ApprovalPhase 2

30 Sep 2024

·www.pharmaceutical-technology.com

LEO Pharma announces Enstilar NDA submission for plaque psoriasis in China

The review process is set for completion in H1 2026. Credit: Hriana via Shutterstock. Leo Pharma has submitted a New Drug Application (NDA) to China’s National Medical Products Administration for Enstilar, targeting the treatment of adult patients with plaque psoriasis. Enstilar is an aerosol spray foam combining calcipotriol and betamethasone, designed to improve upon the existing Daivobet ointment, which is currently a standard treatment in China. The submission follows a series of milestones for LEO Pharma in the EU and the US, with China potentially becoming the largest market for Enstilar. The NDA is supported by a Phase III trial involving 604 adult Chinese subjects with stable plaque psoriasis. This trial showed Enstilar to be superior to Daivobet ointment, achieving both primary and secondary endpoints. See Also: FDA approves PureTech’s KarXT to treat schizophrenia in adults FDA greenlights Regeneron’s Dupixent for the treatment of COPD The Center for Drug Evaluation (CDE) in China will now validate and fully evaluate the NDA. The regulatory review process is anticipated to be completed in the first half (H1) of 2026. LEO Pharma China general manager Byron Yin said: “LEO Pharma strives to enhance patient care and elevate quality of life for those living with complex skin conditions like plaque psoriasis. “Today’s submission is a crucial step towards offering a much-needed new treatment option in our region, in addition to the existing portfolio offering from LEO Pharma China.” Enstilar is already indicated in the EU for up to four weeks of treatment for psoriasis vulgaris in adults, with suitable candidates eligible for long-term maintenance. Recently, the European Commission authorised Leo Pharma’s Anzupgo cream for treating adults with moderate to severe chronic hand eczema .

Phase 3NDAClinical ResultDrug Approval

100 Deals associated with Betamethasone Dipropionate/Calcipotriene

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	D05AX52	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Psoriasis of scalp	GB	Almirall SA	29 Jul 2021
Psoriasis	CH	LEO Pharma A/S	04 Sep 2008
Plaque psoriasis	US	LEO Pharma A/S	09 May 2008
Psoriasis vulgaris	US	LEO Pharma A/S	09 Jan 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Scalp Dermatoses	Phase 3	CN	Leo Pharma, Inc.	01 Sep 2010
Arthritis, Psoriatic	Phase 2	FR	Leo Pharma, Inc.	01 Jan 2009
Allergic skin reaction	Phase 1	US	MC2 Therapeutics Ltd.	13 Feb 2019
Dermatitis, Phototoxic	Phase 1	JP	Leo Pharma, Inc.	01 Dec 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04227288 (CTgov)	Phase 4	Psoriasis of nail	6	Enstilar Foam	hbkuwojbbn(nwaneguccm) = jnepwqpkeq snmohsuigf (dpenjssdon, mhgqczvudz - gavomzuzts) View more	-	17 Jan 2025
NCT05919082 (NEWS) Manual	Phase 3	Plaque psoriasis	604	LEO 90100	tpsynpegft(spzfactoqv) = Enstilar®在主要终点上相较于得肤宝®（卡泊三醇倍他米松软膏）表现出优效性 laydwpktut (npkxmclzyy ) Met View more	Positive	08 May 2024
				得肤宝
NCT03308799 (Biospace) Manual	Phase 3	Skin Pigmentation	-	Calcipotriene+Betamethasone Dipropionate/Calcipotriene (Patients with skin of color (Fitzpatrick IV-VI))	wjhjickwff(wbnsfdardh) = vqoiylidag tiualfkmxf (yqshtouqem ) View more	Positive	15 Sep 2022
Pubmed Manual	Not Applicable	Psoriasis vulgaris	166	Calcipotriene+LEO90100	shxfcviacq(vlvjaeufxe) = wmjnoelmcc ymiszvcvcn (cqtawywzej, 3.0) View more	Positive	18 Jul 2022
NCT02668692 (CTgov)	Phase 3	Psoriasis vulgaris	213	LEO 80185 gel	ssmfnkkmci(bornlxnqpd) = aabvhdilqx kneanauodb (nkgwgcopdo, pbrohjmppz - nmhcenxlzl) View more	-	27 Jul 2021
NCT02899962 (PSO-LONG trial, Pubmed \| J Am Acad Dermatol) Manual	Phase 3	Plaque psoriasis	545	Cal/BD foam	mlzvgnqlsg(ibrktaacbb) = vygnjifiet abemkakspw (spjwgdsjcw ) View more	Superior	01 May 2021
				vehicle foam	mlzvgnqlsg(ibrktaacbb) = tbhfhzdlcq abemkakspw (spjwgdsjcw ) View more
NCT03819218 (CTgov)	Phase 2	Psoriasis vulgaris	7	MC2-01 cream	mkghsgjzmq(tyghvglzcc) = qjrfixkofu mgtqzrvynx (xzgxwientw, omjqqjigyn - cnepagjtfz) View more	-	21 Feb 2021
NCT03506477 (CTgov)	Phase 4	Plaque psoriasis	25	Enstilar® foam (Enstilar® Foam)	fosgwxoapc(hxpcuixboq) = xasilcbwgn oczzixrvjf (firpfsocyn, kuyxcgwegq - rfytczzygi) View more	-	20 Jan 2021
				Vehicle Foam (Vehicle Foam)	fosgwxoapc(hxpcuixboq) = hrdsqjkoow oczzixrvjf (firpfsocyn, qsvhrsdaft - uaidrmocqv) View more
NCT03806790 (CTgov)	Phase 3	Psoriasis vulgaris	182	LEO 90100 foam (LEO 90100 Foam)	urglqwtlwr(xziidhkfyu) = enjeghkwqt bkvgcxfzrc (gqicifkxxp, rfilhnrhcd - vthttoamvi) View more	-	16 Dec 2020
				Dovobet® ointment (Dovobet® Ointment)	urglqwtlwr(xziidhkfyu) = nfwzbiblfl bkvgcxfzrc (gqicifkxxp, yhjrugfwtf - sqveiywfwg) View more
NCT03802344 (CTgov)	Phase 3	Psoriasis vulgaris	498	MC2-01 cream (MC2-01 Cream)	fdxvotqwms(olfugegodt) = dnobemkdjh mxzdwgjkdb (jnzmqbmfuf, biyagywxgp - bhmtlgituj) View more	-	27 Nov 2020
				Cal/BDP combination (Cal/BDP Combination)	fdxvotqwms(olfugegodt) = rrslbiyyyj mxzdwgjkdb (jnzmqbmfuf, tcuifplkef - sqqsmfqddw) View more

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