{"id":239,"date":"2024-04-30T00:18:51","date_gmt":"2024-04-29T17:18:51","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=239"},"modified":"2024-04-30T00:18:51","modified_gmt":"2024-04-29T17:18:51","slug":"technoderma-medicines-advances-tdm-180935-atopic-dermatitis-clinical-program-with-phase-2-trial","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=239","title":{"rendered":"Technoderma Medicines Advances TDM-180935 Atopic Dermatitis Clinical Program with Phase 2 Trial"},"content":{"rendered":"<p><span class=\"legendSpanClass\"><span class=\"xn-location\">CHENGDU, China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">April 29, 2024<\/span><\/span> \/PRNewswire\/ &#8212; Technoderma\u00a0Medicines,\u00a0Inc.\u00a0(&#8220;the Company&#8221;),\u00a0a\u00a0clinical stage\u00a0biopharmaceutical company,\u00a0is\u00a0pleased to\u00a0report the Company\u00a0has\u00a0begun\u00a0dosing\u00a0patients in its\u00a0Phase 2a clinical trial\u00a0(NCT06363461) of topical TDM-180935 ointment. This\u00a0clinical trial\u00a0in\u00a0the\u00a0Atopic\u00a0Dermatitis\u00a0(AD)\u00a0program\u00a0includes 8 weeks dosing of two different\u00a0active\u00a0formulation\u00a0strengths\u00a0and\u00a0placebo\u00a0in a study entitled, &#8220;A\u00a0Randomized, Vehicle-Controlled,\u00a0Parallel Group Study\u00a0of Topical\u00a0TDM-180935 to\u00a0Evaluate the\u00a0Preliminary\u00a0Efficacy, Safety, Tolerability, and\u00a0Pharmacokinetics\u00a0in Atopic Dermatitis\u00a0Patients&#8221;.\u00a0It\u00a0is a\u00a0randomized, vehicle-controlled,\u00a0parallel group comparison study with\u00a0an open-label\u00a0PK sub-study.\u00a0 Objectives are to evaluate the\u00a0safety\u00a0and\u00a0efficacy of topical TDM-180935\u00a0as\u00a0well aspharmacokinetics. Seven\u00a0U.S. clinical sites\u00a0are\u00a0currently\u00a0participating\u00a0in this\u00a0study\u00a0under\u00a0an\u00a0open IND with\u00a0FDA.<\/p>\n<p>Arthur\u00a0P.\u00a0Bertolino,\u00a0MD,\u00a0PhD,\u00a0MBA, Chief\u00a0Medical Officer at Technoderma Medicines commented, &#8220;We expect the current study to support Proof-of-Concept for TDM-180935 regarding efficacy and to guide choice of formulation strength(s) appropriate for\u00a0continued development\u00a0in\u00a0our\u00a0AD\u00a0program. We\u00a0are\u00a0encouraged\u00a0by the selective advantages that\u00a0maybe\u00a0provided by TDM-180935 as\u00a0a\u00a0potent JAK1\/Tyk2 small\u00a0molecule\u00a0inhibitor.&#8221;<\/p>\n<p>&#8220;We are\u00a0pleased with the excellent toleration and\u00a0minimal systemic\u00a0absorption\u00a0already\u00a0exhibited\u00a0by\u00a0TDM-180935 ointment\u00a0in\u00a0Phase\u00a01 development and\u00a0now\u00a0look forward to\u00a0assessing\u00a0its\u00a0preliminary\u00a0efficacy\u00a0in Atopic\u00a0Dermatitis. The advancement of this second\u00a0program\u00a0in our\u00a0portfolio\u00a0into\u00a0Phase\u00a02\u00a0development validates\u00a0our capabilities\u00a0in developing\u00a0multiple\u00a0pipeline\u00a0products for treatment of\u00a0dermatologic diseases,&#8221; said\u00a0Zengquan Wang, Chief\u00a0Executive\u00a0Officer\u00a0at\u00a0Technoderma Medicines. &#8220;We are working to\u00a0bring a steady stream of\u00a0pipeline products\u00a0into\u00a0clinical testing.&#8221;<\/p>\n<p>About TDM-180935<\/p>\n<p>TDM-180935 is a small molecule drug candidate being developed as a topical drug for treatment of\u00a0Atopic\u00a0Dermatitis. As a\u00a0potent JAK1\/Tyk2 small\u00a0molecule inhibitor,\u00a0it\u00a0may offer significant\u00a0advantages regarding efficacy and safety compared to\u00a0existing topical\u00a0treatments.\u00a0Preclinical\u00a0assessment\u00a0of\u00a0TDM-180935\u00a0has demonstrated efficacy\u00a0in\u00a0multiple models and that\u00a0it\u00a0is well-suited for topical administration.\u00a0Functional cell assays demonstrate that TDM-180935 can\u00a0effectively\u00a0suppress\u00a0both\u00a0keratinocyte- and T cell-derived\u00a0pathogenic\u00a0pathways characteristic for Atopic\u00a0Dermatitis. Testing\u00a0in\u00a0rats and\u00a0minipigs demonstrated favorable toxicology and toxicokinetic\u00a0profiles.\u00a0Phase\u00a01 clinical testing\u00a0of\u00a0topical TDM-180935 ointment\u00a0has demonstrated excellent toleration and\u00a0minimal\u00a0systemic\u00a0absorption.<\/p>\n<p>About Atopic\u00a0Dermatitis (AD)<\/p>\n<p>Atopic\u00a0Dermatitis\u00a0(AD), also called eczema,\u00a0is a\u00a0chronic\u00a0relapsing\u00a0pruritic inflammatory skin disorder that typically affects the face, neck, hands and feet, and flexor aspects of extremities. Depending on disease stages (acute, subacute, chronic), typical AD lesions include redness, swelling, cracked or excoriated skin, scaly erythema or plaques with or without\u00a0exudates,\u00a0and\u00a0lichenification, accompanied by severe pruritus and skin dryness. Repeated scratching triggers a self-perpetuating itch-scratch cycle, which can have a significant impact on quality of life. The worldwide prevalence of AD is estimated to be 15-20% in\u00a0children and 1-3% in adults, and the incidence has increased by 2- to 3-fold during the past decades in industrialized countries. The pathogenesis of AD involves four major aspects: disruption of skin barrier\u00a0 function, exposure to allergens, microbial infection, and dysregulated\u00a0immune function. There\u00a0are\u00a0two\u00a0 major\u00a0risk factors of developing AD: one\u00a0is the genetic\u00a0defect\u00a0in the\u00a0gene\u00a0FLG\u00a0encoding\u00a0profilaggrin,\u00a0the precursor of filaggrin\u00a0protein\u00a0present\u00a0in the granular\u00a0layer of the epidermis where\u00a0it\u00a0brings\u00a0structural\u00a0proteins together to create a strong\u00a0barrier\u00a0matrix; the other\u00a0major\u00a0risk factor\u00a0is\u00a0a\u00a0family\u00a0history\u00a0of atopic diseases such as food allergy,\u00a0allergic rhinitis,\u00a0and\u00a0asthma.<\/p>\n<p>About Technoderma\u00a0Medicines<\/p>\n<p>Technoderma\u00a0Medicines,\u00a0Inc.\u00a0is a\u00a0privately\u00a0held clinical stage\u00a0biopharmaceutical company\u00a0located\u00a0in\u00a0Chengdu Tianfu\u00a0BioPark, <span class=\"xn-location\">Sichuan, China<\/span>. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic\u00a0Dermatitis,\u00a0Psoriasis and\u00a0Lupus\u00a0Erythematosus.\u00a0Its\u00a0&#8220;first-in- class&#8221; small\u00a0molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia\u00a0successfully completed\u00a0Phase 2a clinical testing and\u00a0is further\u00a0advancing in\u00a0development. Technoderma&#8217;s\u00a0novel\u00a0JAK1\/TYK2\u00a0inhibitor TDM-180935 for Atopic\u00a0Dermatitis\u00a0completed Phase\u00a01 clinical testing with a\u00a0favorable safety\u00a0profile\u00a0and\u00a0is\u00a0now entering\u00a0Ph2a testing. The\u00a0pipeline targets dermatologic indications.<\/p>\n<p>INVESTOR AND\u00a0MEDIA CONTACT<\/p>\n<p>Technoderma Medicines,\u00a0Inc.<br \/>Zengquan Wang,\u00a0PhD, CEO<br \/><a href=\"mailto:info@tkskin.com\" target=\"_blank\" rel=\"noopener\">info@tkskin.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>CHENGDU, China, April 29, 2024 \/PRNewswire\/ &#8212; Tec [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":[],"rop_publish_now_history":[],"rop_publish_now_status":"pending","footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-239","post","type-post","status-publish","format-standard","hentry","category-cision-pr-newswire","category-cision-pr-newswire-en"],"_links":{"self":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/239","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=239"}],"version-history":[{"count":0,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=\/wp\/v2\/posts\/239\/revisions"}],"wp:attachment":[{"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=239"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=239"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/thaipropertynews.com\/feeds\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=239"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}