Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects
Hoth Therapeutics (NASDAQ: HOTH) announced breakthrough interim results for its HT-001 Phase 2a clinical trial, achieving a 100% response rate in at least one primary endpoint for treating EGFR inhibitor-induced skin toxicities. The trial demonstrated that over 65% of patients reported reduced pain and itching, with no patients requiring dose reduction or discontinuation of their cancer treatment.
HT-001, a once-daily topical gel containing an FDA-approved NK1 receptor antagonist, targets inflammatory pathways triggered by EGFR inhibition. The therapy showed significant efficacy in preclinical studies and is being developed under the 505(b)(2) regulatory pathway, positioning it to potentially become the first FDA-approved treatment specifically for EGFRI-related skin toxicities, which affect up to 90% of cancer patients receiving EGFR inhibitors.
Hoth Therapeutics (NASDAQ: HOTH) ha annunciato risultati intermedi rivoluzionari per il suo studio clinico HT-001 di fase 2a, raggiungendo un tasso di risposta del 100% in almeno un endpoint primario nel trattamento delle tossicità cutanee indotte dagli inibitori EGFR. Lo studio ha dimostrato che oltre il 65% dei pazienti ha riportato una riduzione di dolore e prurito, senza che nessun paziente abbia dovuto ridurre la dose o interrompere il trattamento oncologico.
HT-001, un gel topico da applicare una volta al giorno contenente un antagonista del recettore NK1 approvato dalla FDA, agisce sulle vie infiammatorie attivate dall’inibizione EGFR. La terapia ha mostrato un’efficacia significativa negli studi preclinici ed è sviluppata secondo il percorso regolatorio 505(b)(2), posizionandosi come potenziale primo trattamento approvato dalla FDA specificamente per le tossicità cutanee correlate agli EGFRI, che colpiscono fino al 90% dei pazienti oncologici in trattamento con inibitori EGFR.
Hoth Therapeutics (NASDAQ: HOTH) anunció resultados intermedios revolucionarios para su ensayo clínico de fase 2a HT-001, alcanzando una tasa de respuesta del 100% en al menos un criterio principal para el tratamiento de toxicidades cutáneas inducidas por inhibidores de EGFR. El ensayo demostró que más del 65% de los pacientes reportaron reducción del dolor y picazón, sin que ningún paciente necesitara reducir la dosis o suspender su tratamiento contra el cáncer.
HT-001, un gel tópico de aplicación diaria que contiene un antagonista del receptor NK1 aprobado por la FDA, actúa sobre las vías inflamatorias desencadenadas por la inhibición de EGFR. La terapia mostró una eficacia significativa en estudios preclínicos y se está desarrollando bajo la vía regulatoria 505(b)(2), posicionándose como el primer tratamiento aprobado por la FDA específicamente para toxicidades cutáneas relacionadas con EGFRI, que afectan hasta al 90% de los pacientes oncológicos que reciben inhibidores de EGFR.
Hoth Therapeutics (NASDAQ: HOTH)는 HT-001 2a상 임상시험의 획기적인 중간 결과를 발표했으며, EGFR 억제제로 인한 피부 독성 치료에서 최소 하나의 주요 평가 지표에서 100% 반응률을 달성했습니다. 시험 결과 65% 이상의 환자가 통증과 가려움이 감소했다고 보고했으며, 암 치료의 용량 감소나 중단이 필요하지 않았습니다.
HT-001은 FDA 승인 NK1 수용체 길항제를 함유한 하루 한 번 도포하는 국소 젤로, EGFR 억제에 의해 촉발된 염증 경로를 표적으로 합니다. 이 치료법은 전임상 연구에서 유의미한 효능을 보였으며, 505(b)(2) 규제 경로를 통해 개발 중으로, EGFRI 관련 피부 독성에 대해 FDA 최초 승인 치료제가 될 가능성이 있습니다. EGFR 억제제를 받는 암 환자의 최대 90%가 영향을 받습니다.
Hoth Therapeutics (NASDAQ : HOTH) a annoncé des résultats intermédiaires révolutionnaires pour son essai clinique de phase 2a HT-001, atteignant un taux de réponse de 100 % pour au moins un critère principal dans le traitement des toxicités cutanées induites par les inhibiteurs de l’EGFR. L’essai a démontré que plus de 65 % des patients ont signalé une réduction de la douleur et des démangeaisons, sans qu’aucun patient n’ait eu besoin de réduire la dose ou d’interrompre son traitement anticancéreux.
HT-001, un gel topique à application quotidienne contenant un antagoniste du récepteur NK1 approuvé par la FDA, cible les voies inflammatoires déclenchées par l’inhibition de l’EGFR. Ce traitement a montré une efficacité significative lors d’études précliniques et est développé selon la procédure réglementaire 505(b)(2), ce qui pourrait en faire le premier traitement approuvé par la FDA spécifiquement pour les toxicités cutanées liées aux EGFRI, qui touchent jusqu’à 90 % des patients cancéreux recevant des inhibiteurs de l’EGFR.
Hoth Therapeutics (NASDAQ: HOTH) gab bahnbrechende Zwischenergebnisse für seine HT-001 Phase-2a-Studie bekannt und erzielte eine 100%ige Ansprechrate bei mindestens einem primären Endpunkt zur Behandlung von durch EGFR-Inhibitoren verursachten Hauttoxizitäten. Die Studie zeigte, dass über 65% der Patienten eine Verringerung von Schmerzen und Juckreiz berichteten, ohne dass bei Patienten eine Dosisreduktion oder ein Abbruch der Krebstherapie erforderlich war.
HT-001, ein einmal täglich anzuwendendes topisches Gel mit einem von der FDA zugelassenen NK1-Rezeptorantagonisten, zielt auf entzündliche Signalwege ab, die durch die EGFR-Hemmung ausgelöst werden. Die Therapie zeigte in präklinischen Studien eine signifikante Wirksamkeit und wird über den 505(b)(2)-Zulassungsweg entwickelt, wodurch sie potenziell die erste von der FDA zugelassene Behandlung speziell für EGFRI-bedingte Hauttoxizitäten werden könnte, die bis zu 90% der Krebspatienten betreffen, die EGFR-Inhibitoren erhalten.
- 100% of patients achieved at least one primary endpoint of clinical dermatologic improvement
- Over 65% of patients experienced reduced pain and itching symptoms
- 0% of patients required dose reduction or discontinuation of cancer treatment
- No serious adverse events reported, demonstrating strong safety profile
- Potential to be first FDA-approved therapy for EGFRI-related skin toxicities
- None.
Insights
Hoth's HT-001 shows promising 100% response rate in Phase 2a trial addressing critical EGFR inhibitor side effects that often disrupt cancer treatment.
The interim Phase 2a results for Hoth Therapeutics' HT-001 represent a potentially significant advancement in supportive oncology care. The reported 100% response rate in at least one primary endpoint for EGFR inhibitor-induced skin toxicities addresses a widespread clinical challenge - up to 90% of cancer patients on EGFR inhibitors experience these dermatologic side effects, which frequently necessitate dose reductions or treatment discontinuation.
What makes these results particularly compelling is that none of the patients required dose reduction or discontinuation of their cancer therapy during treatment with HT-001. This is crucial because maintaining full therapeutic dosing of EGFR inhibitors directly impacts cancer treatment efficacy and patient outcomes. The additional finding that over 65% of patients experienced reductions in pain and pruritus suggests meaningful quality-of-life improvements.
From a mechanistic perspective, HT-001's approach targeting the neuroinflammatory pathway via NK1 receptor antagonism represents a novel strategy. Rather than causing immunosuppression, it specifically addresses the Substance P-driven inflammatory cascade triggered by EGFR inhibition.
The development under the 505(b)(2) regulatory pathway is strategically advantageous, potentially accelerating approval by leveraging existing safety data for the active compound. If successful, HT-001 would become the first FDA-approved therapy specifically for EGFRI-related skin toxicities, filling a significant unmet need across multiple cancer types including non-small cell lung cancer, pancreatic, breast, colorectal, and head and neck cancers.
Hoth Therapeutics' HT-001 Achieves
Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at 3:30PM EST to 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 Jonathan Hale Zippin M.D., Ph.D., and Adam 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. Access/join the event through the following link: https://zoom.us/j/91353016981.
Phase 2a Trial Highlights (CLEER-001)
100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement- Over
65% reported reductions in pain and pruritus (itching) 0% required dose reduction or discontinuation of their EGFRI therapy.- Topical therapy was well tolerated with no serious adverse events.
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
"HT-001 is a breakthrough candidate with the potential to be the first FDA-approved therapy specifically targeting these EGFRI-related skin toxicities," said Robb Knie, CEO of Hoth Therapeutics. "The ability to preserve full-dose cancer treatment while improving patient quality of life addresses a critical unmet need across oncology."
Phase 2a Trial Highlights (CLEER-001)
100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement- Over
65% reported reductions in pain and pruritus (itching) 0% required dose reduction or discontinuation of their EGFRI therapy.- Topical therapy was well tolerated with no serious adverse events.
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.
Supporting Preclinical Data
In preclinical rat models co-treated with erlotinib (5.85 mg/kg/day), HT-001 significantly reduced:
- Dermatitis and alopecia severity
- Inflammatory markers including Substance P and neutrophil activity
- Disease progression even when HT-001 was introduced after symptom onset.
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.
Regulatory and Development Pathway
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:
- IND opened and chronic toxicology completed.
- Phase 2a trial (CLEER-001) currently underway in the
U.S. - Phase 2b/3 trial planning in progress
About Hoth Therapeutics
Hoth Therapeutics, Inc. (NASDAQ: HOTH) is a biopharmaceutical company developing innovative therapies for patients with unmet medical needs. The Company's pipeline includes treatments targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions. For more information, visit: www.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
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FAQ
What are the key results from Hoth Therapeutics' (NASDAQ: HOTH) HT-001 Phase 2a trial?
How does Hoth Therapeutics' HT-001 work to treat EGFR inhibitor skin toxicities?
What percentage of cancer patients experience skin toxicities from EGFR inhibitors?
What is the regulatory pathway for Hoth Therapeutics' HT-001?
What types of cancers are treated with EGFR inhibitors that could benefit from HT-001?
