{"id":863283,"date":"2025-06-24T10:51:38","date_gmt":"2025-06-24T14:51:38","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\/"},"modified":"2025-06-24T10:51:38","modified_gmt":"2025-06-24T14:51:38","slug":"hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\/","title":{"rendered":"Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects"},"content":{"rendered":"<div class=\"xn-newslines\">\n<p class=\"xn-distributor\">PR Newswire<\/p>\n<\/p><\/div>\n<div class=\"xn-content\">\n<p class=\"prntac\">\n        <b><br \/>\n          <i>Hoth Therapeutics&#8217; HT-001 Achieves 100% Response Rate\u00a0in at least one endpoint\u00a0in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities<\/i>.<\/b>\n      <\/p>\n<p>Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at\u00a03:30PM EST\u00a0to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists\u00a0Jonathan Hale Zippin M.D.,\u00a0Ph.D., and\u00a0Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients.\u00a0 Access\/join the event through the following link:\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4455869-1&amp;h=3734374131&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4454206-1%26h%3D3911180385%26u%3Dhttps%253A%252F%252Fzoom.us%252Fj%252F91353016981%26a%3Dhttps%253A%252F%252Fzoom.us%252Fj%252F91353016981&amp;a=https%3A%2F%2Fzoom.us%2Fj%2F91353016981\" target=\"_blank\" rel=\"nofollow\"><b>https:\/\/zoom.us\/j\/91353016981<\/b><\/a>.<\/p>\n<p>\n        <b>Phase 2a Trial Highlights (CLEER-001)<\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement<\/li>\n<li>Over 65% reported reductions in pain and pruritus (itching)<\/li>\n<li>0% required dose reduction or discontinuation of their EGFRI therapy.<\/li>\n<li>Topical therapy was well tolerated with no serious adverse events.<\/li>\n<\/ul>\n<p>\n        <span class=\"legendSpanClass\"><br \/>\n          <span class=\"xn-location\">NEW YORK<\/span><br \/>\n        <\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">June 24, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing targeted therapies for rare and serious inflammatory conditions, today announced that its investigational candidate HT-001 met the primary efficacy endpoint\u00a0in at least one metric\u00a0in 100% of patients in its ongoing Phase 2a clinical study (CLEER-001) evaluating treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities.<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<p>\n          <a href=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.html\" target=\"_blank\" rel=\"nofollow\"><br \/>\n            <img decoding=\"async\" src=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg\" title=\"(PRNewsfoto\/Hoth Therapeutics Inc.)\" alt=\"(PRNewsfoto\/Hoth Therapeutics Inc.)\" \/><br \/>\n          <\/a>\n        <\/p>\n<\/p><\/div>\n<p>EGFR inhibitors, used widely to treat non-small cell lung cancer (NSCLC), pancreatic, breast, colorectal, and head and neck cancers, are associated with dermatologic side effects in up to 90% of patients, often resulting in painful rashes, pruritus, dryness, nail changes, and alopecia. These adverse events frequently force dose reductions or treatment discontinuation, limiting therapeutic efficacy and patient outcomes.<\/p>\n<p>&#8220;HT-001 is a breakthrough candidate with the potential to be the first FDA-approved therapy specifically targeting these EGFRI-related skin toxicities,&#8221; said <span class=\"xn-person\">Robb Knie<\/span>, CEO of Hoth Therapeutics. &#8220;The ability to preserve full-dose cancer treatment while improving patient quality of life addresses a critical unmet need across oncology.&#8221;<\/p>\n<p>\n        <b>Phase 2a Trial Highlights (CLEER-001)<\/b>\n      <\/p>\n<ul type=\"disc\">\n<li>100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement<\/li>\n<li>Over 65% reported reductions in pain and pruritus (itching)<\/li>\n<li>0% required dose reduction or discontinuation of their EGFRI therapy.<\/li>\n<li>Topical therapy was well tolerated with no serious adverse events.<\/li>\n<\/ul>\n<p>HT-001 is a once-daily topical gel formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA). This mechanism mitigates inflammatory pathways triggered by EGFR inhibition, particularly Substance P-driven responses that lead to skin breakdown. By targeting the neuroinflammatory axis, HT-001 reduces symptoms without immunosuppression or systemic toxicity.<\/p>\n<p>\n        <b>Supporting Preclinical Data<\/b>\n      <\/p>\n<p>In preclinical rat models co-treated with erlotinib (5.85 mg\/kg\/day), HT-001 significantly reduced:<\/p>\n<ul type=\"disc\">\n<li>Dermatitis and alopecia severity<\/li>\n<li>Inflammatory markers including Substance P and neutrophil activity<\/li>\n<li>Disease progression even when HT-001 was introduced after symptom onset.<\/li>\n<\/ul>\n<p>Additionally, in compassionate-use human cases, complete symptom resolution was observed within one week, with no recurrence for up to three weeks post-treatment discontinuation.<\/p>\n<p>\n        <b>Regulatory and Development Pathway<\/b>\n      <\/p>\n<p>HT-001 is being advanced under the 505(b)(2) regulatory pathway, enabling the use of existing safety data to accelerate development. Key milestones include:<\/p>\n<ul type=\"disc\">\n<li>IND opened and chronic toxicology completed.<\/li>\n<li>Phase 2a trial (CLEER-001) currently underway in the U.S.<\/li>\n<li>Phase <span class=\"xn-money\">2b<\/span>\/3 trial planning in progress<\/li>\n<\/ul>\n<p>\n        <b>About\u00a0Hoth Therapeutics<br \/><\/b>Hoth Therapeutics, Inc. (NASDAQ: HOTH) is a biopharmaceutical company developing innovative therapies for patients with unmet medical needs. The Company&#8217;s pipeline includes treatments targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions. For more information, visit: <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4455869-1&amp;h=2101110738&amp;u=http%3A%2F%2Fwww.hoththerapeutics.com%2F&amp;a=www.hoththerapeutics.com\" target=\"_blank\" rel=\"nofollow\">www.hoththerapeutics.com<\/a><\/p>\n<p>\n        <b>Forward-Looking Statement<br \/><\/b>This\u00a0press\u00a0release includes\u00a0forward-looking\u00a0statements\u00a0based\u00a0upon\u00a0Hoth&#8217;s current\u00a0expectations,\u00a0which\u00a0may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth&#8217;s business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates\u00a0and\u00a0any\u00a0other\u00a0product candidates\u00a0we\u00a0may\u00a0develop,\u00a0and\u00a0the\u00a0labeling under\u00a0any\u00a0approval we\u00a0may obtain;\u00a0the\u00a0timing\u00a0and\u00a0costs\u00a0of\u00a0clinical\u00a0trials, and\u00a0the\u00a0timing and\u00a0costs\u00a0of\u00a0other\u00a0expenses;\u00a0market\u00a0acceptance of\u00a0our\u00a0products;\u00a0the\u00a0ultimate\u00a0impact of\u00a0the\u00a0current\u00a0coronavirus\u00a0pandemic, or\u00a0any\u00a0other\u00a0health\u00a0epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management&#8217;s expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as &#8220;could,&#8221; &#8220;believe,&#8221; &#8220;anticipate,&#8221; &#8220;intend,&#8221; &#8220;estimate,&#8221; &#8220;expect,&#8221; &#8220;may,&#8221; &#8220;continue,&#8221; &#8220;predict,&#8221; &#8220;potential,&#8221; &#8220;project&#8221; or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual\u00a0results\u00a0may\u00a0differ\u00a0materially\u00a0from\u00a0those\u00a0indicated\u00a0by\u00a0these\u00a0forward-looking\u00a0statements\u00a0as\u00a0a\u00a0result\u00a0of various\u00a0important\u00a0factors,\u00a0including,\u00a0without\u00a0limitation, market\u00a0conditions\u00a0and\u00a0the factors\u00a0described\u00a0in\u00a0the section titled &#8220;Risk Factors&#8221; in Hoth&#8217;s most recent Annual Report on Form 10-K and Hoth&#8217;s other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth&#8217;s current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.<\/p>\n<p>\n        <b>Investor Contact:<br \/><\/b>LR Advisors LLC\u00a0<br \/>Email:\u00a0<a href=\"mailto:investorrelations@hoththerapeutics.com\" target=\"_blank\" rel=\"nofollow\">investorrelations@hoththerapeutics.com<\/a><br \/><a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=4455869-1&amp;h=3887691482&amp;u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D3041986-1%26h%3D537704384%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D2889507-1%2526h%253D1377821239%2526u%253Dhttps%25253A%25252F%25252Fc212.net%25252Fc%25252Flink%25252F%25253Ft%25253D0%252526l%25253Den%252526o%25253D2823479-1%252526h%25253D536261162%252526u%25253Dhttp%2525253A%2525252F%2525252Fwww.hoththerapeutics.com%2525252F%252526a%25253Dwww.hoththerapeutics.com%2526a%253Dwww.hoththerapeutics.com%26a%3Dwww.hoththerapeutics.com&amp;a=www.hoththerapeutics.com\" target=\"_blank\" rel=\"nofollow\">www.hoththerapeutics.com<\/a><br \/>Phone: (678) 570-6791<\/p>\n<p id=\"PURL\">\n        <img loading=\"lazy\" decoding=\"async\" title=\"Cision\" width=\"12\" height=\"12\" alt=\"Cision\" src=\"https:\/\/c212.net\/c\/img\/favicon.png?sn=NY17293&amp;sd=2025-06-24\" \/> View original content to download multimedia:<a id=\"PRNURL\" rel=\"nofollow\" href=\"https:\/\/www.prnewswire.com\/news-releases\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects-302489805.html\" target=\"_blank\">https:\/\/www.prnewswire.com\/news-releases\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects-302489805.html<\/a><\/p>\n<p>SOURCE  Hoth Therapeutics, Inc.<\/p>\n<\/p><\/div>\n<p>    <img decoding=\"async\" alt=\"\" src=\"https:\/\/rt.prnewswire.com\/rt.gif?NewsItemId=NY17293&amp;Transmission_Id=202506241036PR_NEWS_USPR_____NY17293&amp;DateId=20250624\" style=\"border:0px;width:1px;height:1px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PR Newswire Hoth Therapeutics&#8217; HT-001 Achieves 100% Response Rate\u00a0in at least one endpoint\u00a0in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities. Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at\u00a03:30PM EST\u00a0to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists\u00a0Jonathan Hale Zippin M.D.,\u00a0Ph.D., and\u00a0Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients.\u00a0 Access\/join the event through the following link:\u00a0https:\/\/zoom.us\/j\/91353016981. Phase 2a Trial Highlights (CLEER-001) 100% of enrolled patients in open-label cohort achieved at least one &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-863283","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"PR Newswire Hoth Therapeutics&#8217; HT-001 Achieves 100% Response Rate\u00a0in at least one endpoint\u00a0in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities. Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at\u00a03:30PM EST\u00a0to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists\u00a0Jonathan Hale Zippin M.D.,\u00a0Ph.D., and\u00a0Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients.\u00a0 Access\/join the event through the following link:\u00a0https:\/\/zoom.us\/j\/91353016981. Phase 2a Trial Highlights (CLEER-001) 100% of enrolled patients in open-label cohort achieved at least one &hellip; Continue reading &quot;Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-24T14:51:38+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mma.prnewswire.com\/media\/644804\/Hoth_Therapeutics_Logo.jpg\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects\",\"datePublished\":\"2025-06-24T14:51:38+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\\\/\"},\"wordCount\":1077,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mma.prnewswire.com\\\/media\\\/644804\\\/Hoth_Therapeutics_Logo.jpg\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/hoth-therapeutics-ht-001-interim-results-first-in-class-topical-therapy-preserves-cancer-treatment-while-resolving-dermatologic-side-effects\\\/\",\"name\":\"Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects - 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