Hoth Therapeutics Announces Positive Results for HT-001 in Treating EGFR Inhibitor-Associated Papulopustular Eruptions Findings to be Presented at the American Academy of Dermatology 2025 Annual Meeting
Hoth Therapeutics (NASDAQ: HOTH) has announced positive results for HT-001, their topical neurokinin 1 receptor antagonist, in treating EGFR inhibitor-associated skin conditions. A case study demonstrated remarkable efficacy where a 59-year-old metastatic breast cancer patient experienced complete resolution of skin lesions after one week of twice-daily HT-001 2% cream application, with no recurrence in the following three weeks.
The therapy works by blocking the pro-inflammatory SP-NK1R pathway. The company is currently conducting a Phase 2A clinical trial to evaluate HT-001's efficacy and safety in a broader patient population with varying severities of EGFR inhibitor-induced skin reactions.
These findings will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting from March 7-11, 2025, positioning HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.
Hoth Therapeutics (NASDAQ: HOTH) ha annunciato risultati positivi per HT-001, il loro antagonista topico del recettore neurochinina 1, nel trattamento delle condizioni cutanee associate agli inibitori dell'EGFR. Uno studio di caso ha dimostrato un'efficacia notevole, dove una paziente di 59 anni affetta da cancro al seno metastatico ha sperimentato una completa risoluzione delle lesioni cutanee dopo una settimana di applicazione della crema HT-001 al 2% due volte al giorno, senza ricadute nelle tre settimane successive.
La terapia agisce bloccando il percorso pro-infiammatorio SP-NK1R. L'azienda sta attualmente conducendo un trial clinico di Fase 2A per valutare l'efficacia e la sicurezza di HT-001 in una popolazione di pazienti più ampia con diverse gravità delle reazioni cutanee indotte dagli inibitori dell'EGFR.
Questi risultati saranno presentati al Congresso Annuale dell'Accademia Americana di Dermatologia (AAD) 2025 dal 7 all'11 marzo 2025, posizionando HT-001 come una potenziale terapia innovativa per le tossicità dermatologiche indotte dagli inibitori dell'EGFR.
Hoth Therapeutics (NASDAQ: HOTH) ha anunciado resultados positivos para HT-001, su antagonista tópico del receptor de neuroquinina 1, en el tratamiento de condiciones cutáneas asociadas a inhibidores de EGFR. Un estudio de caso demostró una eficacia notable, donde una paciente de 59 años con cáncer de mama metastásico experimentó una resolución completa de las lesiones cutáneas después de una semana de aplicación de crema HT-001 al 2% dos veces al día, sin recaídas en las tres semanas siguientes.
La terapia funciona bloqueando la vía proinflamatoria SP-NK1R. La empresa está llevando a cabo un ensayo clínico de Fase 2A para evaluar la eficacia y seguridad de HT-001 en una población de pacientes más amplia con diferentes severidades de reacciones cutáneas inducidas por inhibidores de EGFR.
Estos hallazgos se presentarán en la Reunión Anual de la Academia Americana de Dermatología (AAD) 2025 del 7 al 11 de marzo de 2025, posicionando a HT-001 como una posible terapia innovadora para las toxicidades dermatológicas inducidas por inhibidores de EGFR.
Hoth Therapeutics (NASDAQ: HOTH)는 EGFR 억제제와 관련된 피부 질환 치료를 위한 국소 신경키닌 1 수용체 길항제 HT-001의 긍정적인 결과를 발표했습니다. 한 사례 연구에서는 59세의 전이성 유방암 환자가 하루 두 번 HT-001 2% 크림을 일주일간 적용한 후 피부 병변이 완전히 해결되었으며, 이후 3주 동안 재발이 없었습니다.
이 요법은 염증 유발 SP-NK1R 경로를 차단함으로써 작용합니다. 현재 회사는 다양한 중증도의 EGFR 억제제 유도 피부 반응을 가진 더 넓은 환자 집단에서 HT-001의 효능과 안전성을 평가하기 위한 2A상 임상 시험을 진행하고 있습니다.
이 결과는 2025년 3월 7일부터 11일까지 열리는 미국 피부과 학회(AAD) 2025 연례 회의에서 발표될 예정이며, HT-001을 EGFR 억제제 유도 피부 독성에 대한 잠재적인 혁신 치료제로 자리매김하게 될 것입니다.
Hoth Therapeutics (NASDAQ: HOTH) a annoncé des résultats positifs pour HT-001, leur antagoniste topique du récepteur neurokinine 1, dans le traitement des affections cutanées associées aux inhibiteurs de l'EGFR. Une étude de cas a démontré une efficacité remarquable, où une patiente de 59 ans atteinte d'un cancer du sein métastatique a connu une résolution complète des lésions cutanées après une semaine d'application de crème HT-001 à 2 % deux fois par jour, sans récidive au cours des trois semaines suivantes.
La thérapie agit en bloquant la voie pro-inflammatoire SP-NK1R. L'entreprise mène actuellement un essai clinique de Phase 2A pour évaluer l'efficacité et la sécurité de HT-001 dans une population de patients plus large présentant des réactions cutanées induites par des inhibiteurs de l'EGFR de différentes gravités.
Ces résultats seront présentés lors de la Réunion Annuelle de l'Académie Américaine de Dermatologie (AAD) 2025 du 7 au 11 mars 2025, positionnant HT-001 comme une thérapie potentiellement révolutionnaire pour les toxicités dermatologiques induites par les inhibiteurs de l'EGFR.
Hoth Therapeutics (NASDAQ: HOTH) hat positive Ergebnisse für HT-001, ihren topischen Neurokinin-1-Rezeptor-Antagonisten, bei der Behandlung von Hauterkrankungen, die mit EGFR-Inhibitoren verbunden sind, bekannt gegeben. Eine Fallstudie zeigte eine bemerkenswerte Wirksamkeit, als eine 59-jährige Patientin mit metastasierendem Brustkrebs nach einer Woche der zweimal täglichen Anwendung von HT-001 2% Creme eine vollständige Abheilung der Hautläsionen erlebte, ohne dass es in den folgenden drei Wochen zu einem Rückfall kam.
Die Therapie wirkt, indem sie den proinflammatorischen SP-NK1R-Weg blockiert. Das Unternehmen führt derzeit eine Phase 2A klinische Studie durch, um die Wirksamkeit und Sicherheit von HT-001 in einer breiteren Patientengruppe mit unterschiedlichen Schweregraden von durch EGFR-Inhibitoren induzierten Hautreaktionen zu bewerten.
Diese Ergebnisse werden auf dem Jahreskongress der American Academy of Dermatology (AAD) 2025 vom 7. bis 11. März 2025 präsentiert, wodurch HT-001 als potenzielle bahnbrechende Therapie für durch EGFR-Inhibitoren induzierte dermatologische Toxizitäten positioniert wird.
- Complete symptom resolution in case study patient within 1 week
- No recurrence of symptoms for 3 weeks post-treatment
- Advancement to Phase 2A clinical trials
- Potential breakthrough therapy status for unmet medical need
- data from single patient case study
- Early-stage clinical development - not yet market ready
Insights
Hoth Therapeutics' HT-001 shows promising efficacy in treating EGFR inhibitor-associated skin toxicities - a significant unmet need in cancer supportive care. The case study involving a metastatic breast cancer patient demonstrated complete symptom resolution after only one week of treatment with no recurrence over the subsequent three weeks.
This finding is clinically meaningful as dermatologic toxicities from EGFR inhibitors often lead to therapy dose reductions, interruptions, or discontinuations, potentially compromising cancer treatment outcomes. HT-001's mechanism targeting the Substance P-NK1R inflammatory pathway addresses the underlying pathophysiology rather than just symptomatically treating these reactions.
The advancement to Phase 2A clinical trials represents a significant developmental milestone, moving beyond preclinical and early safety studies. However, investors should recognize that while this single case report is encouraging, comprehensive efficacy and safety data from the ongoing Phase 2A trial will be more definitive in establishing HT-001's therapeutic value.
For context, EGFR inhibitor-associated rashes affect 70-80% of patients receiving these targeted cancer therapies. Current management options are and often inadequate, potentially creating a substantial market opportunity if HT-001 maintains this efficacy profile in larger studies.
For Hoth Therapeutics (market cap:
HT-001 targets the substantial supportive care market in oncology - specifically the estimated 300,000+ patients annually who develop EGFR inhibitor-induced skin toxicities. This represents a focused but potentially lucrative commercial opportunity with competition from specifically-designed therapeutics.
The progression to Phase 2A trials demonstrates developmental momentum, though investors should note several critical value-inflection points remain before commercialization. The rapid efficacy signal (full symptom resolution within one week) could differentiate HT-001 in the market if replicated in larger trials.
From a competitive standpoint, current management approaches for these dermatologic toxicities primarily involve symptom management with topical steroids, antibiotics, and dose modifications - none specifically targeting the underlying NK1R pathway. This novel approach could potentially command premium pricing if approved.
While encouraging, investors should recognize that full Phase 2A results will be more determinative of HT-001's commercial potential than this single case study, and that several years of development likely remain before potential commercialization.
The data will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, which takes place March 7-11, 2025, highlighting HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.
The recent case study will be highlighted that demonstrated the efficacy of HT-001
The data will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, which takes place March 7-11, 2025, highlighting HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.
A recent case study demonstrated the efficacy of HT-001
"These findings demonstrate the potential of HT-001 as a safe and effective therapy for EGFR inhibitor-associated skin toxicities," said Robb Knie, CEO at Hoth Therapeutics. "With a significant unmet need for long-term, well-tolerated treatment options, HT-001 could offer relief to cancer patients experiencing debilitating skin reactions."
HT-001 works by blocking the pro-inflammatory effects of the Substance P (SP)-NK1R pathway, a key mediator of neurogenic inflammation. Preclinical research has shown that HT-001 reduces inflammation and hair loss associated with EGFR inhibitor therapy. These latest clinical observations further support its potential role in dermatologic oncology.
Hoth Therapeutics is currently conducting a Phase 2A clinical trial to evaluate the efficacy and safety of HT-001 in a broader patient population. The trial will assess the treatment's effectiveness across varying severities of EGFRi PPEs and explore its impact on other dermatologic manifestations induced by EGFR inhibitors.
For more information about HT-001 and ongoing clinical trials, visit www.hoththerapeutics.com
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations, which may 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's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, 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'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 "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" 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 results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth'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'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.
Investor Contact:
LR Advisors LLC Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-announces-positive-results-for-ht-001-in-treating-egfr-inhibitor-associated-papulopustular-eruptions-findings-to-be-presented-at-the-american-academy-of-dermatology-2025-annual-meeting-302393579.html
SOURCE Hoth Therapeutics, Inc.
FAQ
What are the clinical results of Hoth Therapeutics' HT-001 treatment for EGFR inhibitor skin reactions?
How does Hoth Therapeutics' HT-001 work to treat EGFR inhibitor-associated skin conditions?
What is the current development stage of HOTH's HT-001 treatment?
When will HOTH present the HT-001 clinical findings?
