Efficacy of p62-expressing plasmid in treatment of canine ATOPIC DERMATITIS: A Pilot study IN companion dogs

Efficacy of p62-expressing plasmid in treatment of canine ATOPIC DERMATITIS: A Pilot study IN companion dogs | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Efficacy of p62-expressing plasmid in treatment of canine ATOPIC DERMATITIS: A Pilot study IN companion dogs Vladimir Gabai, Evgeny Bakin, Maxim Langs, Robert Delvin, Alexis Nahama, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9223428/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background : Canine Atopic Dermatitis (AD) is a genetically predisposed chronic inflammatory and pruritic allergic skin disease. Despite several drugs for treatment of AD, there are still unmet needs for therapies that have significant clinical response, yet minimal adverse effects. Objective : We have recently developed a plasmid DNA encoding SQSTM1/p62, which demonstrated efficacy in preclinical models of inflammatory diseases as well as in osteoarthritis pain in dogs. Here we test a hypothesis that the p62 plasmid may alleviate severity of AD symptoms associated with the chronic inflammatory nature of the disease. Animals : Twenty privately owned animals with diagnosed severe chronic AD Materials and methods : This was single arm open label study. All dogs were treated with p62 plasmid (1 mg) weekly either intramuscular or subcutaneously (10 dogs in each group) and AD severity by pVAS score was assessed weekly for 11 wks. Results : Treatment with p62 plasmid decreased pVAS score from baseline 8.05+/- 1.36 to 5.52+/- 1.8 (mean+/-SD) with a highly significant statistical difference (P=10 -5 ). The effect of the p62 plasmid treatment were developed over time, starting within 2 weeks and with a maximum effect after 7 weeks. Estimated average decrease in pVAS score was 0.23 per week with high statistical significance (). There were no side effects reported. Given the severity of AD, some owners were allowed to continue administration of the same AD medications (steroids or Apoquel®), which they used before. No potential interaction (positive or negative) with p62 plasmid was observed. conclusion and clinical relevance: The p62 plasmid demonstrated modest but statistically significant alleviation of AD in dogs without observed side effects. These results are encouraging to conduct further trials. Translational Medicine DNA vaccine inflammation clinical trial plasmid immunotherapy canine Full Text Additional Declarations The authors declare potential competing interests as follows: VG, RD, AN and AS were employed by CureLab Veterinary Inc. SG was employed by BELVITUNIFARM. EB was employed by CytoReason LTD. Ethics Statement Formal ethical approval was not required for this study under Belarusian legislation or institutional policy. National regulations specify that research involving client‑owned animals undergoing routine diagnostic or therapeutic procedures does not require review by an animal ethics committee. All procedures were performed as part of standard clinical care, and written informed consent was obtained from all owners prior to enrollment. This is consistent with international guidance for veterinary clinical research in privately owned animals, including the principles outlined by the World Organisation for Animal Health and the International Association of Veterinary Editors. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9223428","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":612663471,"identity":"2902dbc3-3db9-44d1-a773-e037dc846be4","order_by":0,"name":"Vladimir Gabai","email":"","orcid":"","institution":"CureLab Veterinary, Boston, USA","correspondingAuthor":false,"prefix":"","firstName":"Vladimir","middleName":"","lastName":"Gabai","suffix":""},{"id":612673966,"identity":"8f0d557f-9270-41a5-878d-0d2ad017b681","order_by":1,"name":"Evgeny Bakin","email":"","orcid":"","institution":"CytoReason LTD, Tel-Aviv, Israel","correspondingAuthor":false,"prefix":"","firstName":"Evgeny","middleName":"","lastName":"Bakin","suffix":""},{"id":612675205,"identity":"82a9596d-7fa4-4337-acf3-20a3d47b147f","order_by":2,"name":"Maxim Langs","email":"","orcid":"","institution":"Miramonte High School, CA, USA","correspondingAuthor":false,"prefix":"","firstName":"Maxim","middleName":"","lastName":"Langs","suffix":""},{"id":612675206,"identity":"7e9071d3-073a-43e3-985d-eaea56946daf","order_by":3,"name":"Robert Delvin","email":"","orcid":"","institution":"CureLab Veterinary, Boston, USA","correspondingAuthor":false,"prefix":"","firstName":"Robert","middleName":"","lastName":"Delvin","suffix":""},{"id":612675207,"identity":"f312280e-3ea7-4344-9340-5857c98e3a93","order_by":4,"name":"Alexis Nahama","email":"","orcid":"","institution":"CureLab Veterinary, Boston, USA","correspondingAuthor":false,"prefix":"","firstName":"Alexis","middleName":"","lastName":"Nahama","suffix":""},{"id":612683052,"identity":"6e400cc9-e82a-415b-bee6-c473195fb191","order_by":5,"name":"Sergei Krasny","email":"","orcid":"","institution":"N.N. 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SG was employed by BELVITUNIFARM. EB was employed by CytoReason LTD.\u003c/p\u003e\n\u003cp\u003eEthics Statement Formal ethical approval was not required for this study under Belarusian legislation or institutional policy. National regulations specify that research involving client‑owned animals undergoing routine diagnostic or therapeutic procedures does not require review by an animal ethics committee. All procedures were performed as part of standard clinical care, and written informed consent was obtained from all owners prior to enrollment. This is consistent with international guidance for veterinary clinical research in privately owned animals, including the principles outlined by the World Organisation for Animal Health and the International Association of Veterinary Editors.\u003c/p\u003e","formattedTitle":"\u003cp\u003e\u003cstrong\u003eEfficacy of p62-expressing plasmid in treatment of canine ATOPIC DERMATITIS: A Pilot study IN companion dogs\u003c/strong\u003e\u003c/p\u003e","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"CureLab Veterinary","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"DNA vaccine, inflammation, clinical trial, plasmid, immunotherapy, canine","lastPublishedDoi":"10.21203/rs.3.rs-9223428/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9223428/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Canine Atopic Dermatitis (AD) is a genetically predisposed chronic inflammatory and pruritic allergic skin disease. Despite several drugs for treatment of AD, there are still unmet needs for therapies that have significant clinical response, yet minimal adverse effects.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e: We have recently developed a plasmid DNA encoding SQSTM1/p62, which demonstrated efficacy in preclinical models of inflammatory diseases as well as in osteoarthritis pain in dogs. Here we test a hypothesis that the p62 plasmid may alleviate severity of AD symptoms associated with the chronic inflammatory nature of the disease.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnimals\u003c/strong\u003e: Twenty privately owned animals with diagnosed severe chronic AD\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and methods\u003c/strong\u003e: This was single arm open label study. All dogs were treated with p62 plasmid (1 mg) weekly either intramuscular or subcutaneously (10 dogs in each group) and AD severity by pVAS score was assessed weekly for 11 wks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Treatment with p62 plasmid decreased pVAS score from baseline 8.05+/- 1.36 to 5.52+/- 1.8 (mean+/-SD) with a highly significant statistical difference (P=10\u003csup\u003e-5\u003c/sup\u003e). The effect of the p62 plasmid treatment were developed over time, starting within 2 weeks and with a maximum effect after 7 weeks. Estimated average decrease in pVAS score was 0.23 per week with high statistical significance (). There were no side effects reported. Given the severity of AD, some owners were allowed to continue administration of the same AD medications (steroids or Apoquel®), which they used before. 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