Hoth Therapeutics Announces Positive Initial Data in Phase 2a Clinical Trial
Hoth Therapeutics (NASDAQ: HOTH) has reported positive interim data from the open-label portion of its Phase 2a CLEER-001 clinical trial for HT-001, a treatment targeting pruritus associated with EGFR inhibitor-induced skin toxicities in cancer patients.
The key interim results from Day 1-21 demonstrate:
- A 50% reduction in pruritus severity (mean scores decreased from 1.6 to 0.8)
- Rapid symptom improvement by Day 7 (mean score: 1.0)
- Complete pruritus resolution in some patients
- No treatment-related serious adverse events reported
The CLEER-001 study continues with both cohorts active, including the randomized, double-blind portion of the trial. The treatment aims to address quality of life issues and treatment compliance challenges faced by cancer patients using EGFR inhibitors.
Hoth Therapeutics (NASDAQ: HOTH) ha riportato dati positivi preliminari dalla fase open-label del suo studio clinico di Fase 2a CLEER-001 per HT-001, un trattamento mirato al prurito associato alle tossicità cutanee indotte dagli inibitori di EGFR nei pazienti oncologici.
I principali risultati intermedi dal Giorno 1 al 21 mostrano:
- Una riduzione del 50% della gravità del prurito (i punteggi medi sono diminuiti da 1,6 a 0,8)
- Un rapido miglioramento dei sintomi entro il Giorno 7 (punteggio medio: 1,0)
- Risoluzione completa del prurito in alcuni pazienti
- Nessun evento avverso grave correlato al trattamento riportato
Lo studio CLEER-001 prosegue con entrambi i gruppi attivi, inclusa la parte randomizzata e in doppio cieco della sperimentazione. Il trattamento mira a migliorare la qualità della vita e a facilitare l’aderenza alla terapia nei pazienti oncologici che utilizzano inibitori di EGFR.
Hoth Therapeutics (NASDAQ: HOTH) ha informado datos interinos positivos de la fase abierta de su ensayo clínico de fase 2a CLEER-001 para HT-001, un tratamiento dirigido al prurito asociado con toxicidades cutáneas inducidas por inhibidores de EGFR en pacientes con cáncer.
Los resultados clave interinos del Día 1 al 21 demuestran:
- Una reducción del 50% en la gravedad del prurito (las puntuaciones medias disminuyeron de 1,6 a 0,8)
- Mejora rápida de los síntomas para el Día 7 (puntuación media: 1,0)
- Resolución completa del prurito en algunos pacientes
- No se reportaron eventos adversos graves relacionados con el tratamiento
El estudio CLEER-001 continúa con ambas cohortes activas, incluyendo la parte aleatorizada y doble ciego del ensayo. El tratamiento busca abordar los problemas de calidad de vida y los desafíos de cumplimiento terapéutico que enfrentan los pacientes con cáncer que usan inhibidores de EGFR.
Hoth Therapeutics (NASDAQ: HOTH)는 EGFR 억제제로 인한 피부 독성과 관련된 가려움증을 치료하는 HT-001의 2a상 임상시험 CLEER-001의 공개 라벨 구간에서 긍정적인 중간 데이터를 보고했습니다.
1일차부터 21일차까지의 주요 중간 결과는 다음과 같습니다:
- 가려움증 심각도 50% 감소 (평균 점수가 1.6에서 0.8로 감소)
- 7일차까지 빠른 증상 개선 (평균 점수: 1.0)
- 일부 환자에서 가려움증 완전 해소
- 치료 관련 심각한 이상반응 보고 없음
CLEER-001 연구는 무작위 배정 및 이중맹검 구간을 포함하여 두 집단 모두 활성 상태로 계속 진행 중입니다. 이 치료는 EGFR 억제제를 사용하는 암 환자들이 겪는 삶의 질 문제와 치료 순응도 문제를 해결하는 것을 목표로 합니다.
Hoth Therapeutics (NASDAQ : HOTH) a rapporté des données intermédiaires positives de la phase en ouvert de son essai clinique de phase 2a CLEER-001 pour HT-001, un traitement ciblant le prurit associé aux toxicités cutanées induites par les inhibiteurs de l’EGFR chez les patients atteints de cancer.
Les résultats intermédiaires clés du jour 1 au jour 21 montrent :
- Une réduction de 50 % de la sévérité du prurit (les scores moyens sont passés de 1,6 à 0,8)
- Une amélioration rapide des symptômes dès le jour 7 (score moyen : 1,0)
- Une résolution complète du prurit chez certains patients
- Aucun événement indésirable grave lié au traitement rapporté
L’étude CLEER-001 se poursuit avec les deux cohortes actives, y compris la partie randomisée en double aveugle de l’essai. Le traitement vise à améliorer la qualité de vie et à faciliter l’observance thérapeutique chez les patients cancéreux utilisant des inhibiteurs de l’EGFR.
Hoth Therapeutics (NASDAQ: HOTH) hat positive Zwischenergebnisse aus dem offenen Teil seiner Phase-2a-Studie CLEER-001 für HT-001 veröffentlicht, einer Behandlung, die auf Juckreiz im Zusammenhang mit durch EGFR-Inhibitoren verursachten Hauttoxizitäten bei Krebspatienten abzielt.
Die wichtigsten Zwischenergebnisse von Tag 1 bis 21 zeigen:
- Eine 50%ige Reduktion der Juckreizintensität (durchschnittliche Werte sanken von 1,6 auf 0,8)
- Schnelle Symptomverbesserung bis Tag 7 (Durchschnittswert: 1,0)
- Vollständige Juckreizfreiheit bei einigen Patienten
- Keine berichteten schwerwiegenden behandlungsbedingten Nebenwirkungen
Die CLEER-001-Studie läuft weiterhin mit beiden Kohorten aktiv, einschließlich des randomisierten, doppelblinden Teils der Studie. Die Behandlung zielt darauf ab, Lebensqualitätsprobleme und Herausforderungen bei der Therapietreue von Krebspatienten, die EGFR-Inhibitoren verwenden, zu adressieren.
- 50% reduction in pruritus severity achieved in Phase 2a trial
- Rapid symptom improvement demonstrated within 7 days
- Complete resolution of symptoms in some patients
- No treatment-related serious adverse events reported
- Addresses significant unmet medical need in cancer treatment
- Early-stage trial data (Phase 2a) - still requires further clinical validation
- data from open-label portion only - double-blind results pending
Insights
Hoth Therapeutics' interim Phase 2a data for HT-001 shows promising efficacy in addressing EGFR inhibitor-induced pruritus, a significant challenge in cancer care. The 50% reduction in pruritus severity (from 1.6 to 0.8) by day 21 represents clinically meaningful symptom improvement.
What's particularly notable is the rapid onset of action, with scores improving to 1.0 by day 7, and some patients achieving complete symptom resolution. This quick relief addresses an urgent patient need, as EGFR inhibitor-related skin toxicities often lead to treatment discontinuation or dose reductions, potentially compromising cancer outcomes.
The clean safety profile, with no treatment-related serious adverse events, is equally important. For context, EGFR inhibitors are crucial therapies in several cancers including lung, colorectal, and head and neck malignancies, but up to
While these early results are encouraging, several contextual factors deserve consideration: this represents interim data from the open-label portion of the study, which lacks a control arm for comparison. The subsequent randomized, double-blind portion will provide more definitive evidence of efficacy. Additionally, the sample size isn't specified, which limits our ability to draw robust conclusions.
Nevertheless, if these results are confirmed in larger studies, HT-001 could significantly improve cancer patients' quality of life and potentially enhance adherence to life-saving EGFR inhibitor therapies.
Hoth's interim Phase 2a results for HT-001 represent a significant milestone for this micro-cap biotech (
The data's strength lies in three key metrics: the magnitude of symptom reduction, rapid onset of action (meaningful improvement by day 7), and the clean safety profile. These factors position HT-001 as a potential companion treatment to EGFR inhibitors, which generate billions in annual revenue treating various cancers.
For investors, this represents a meaningful de-risking event, though several hurdles remain. The company must still complete the randomized, controlled portion of this study and likely conduct larger Phase 3 trials before commercialization becomes possible. The focused indication represents a specialized market – significant enough to transform Hoth's prospects but not a blockbuster-sized opportunity.
While board member departures sometimes raise concerns, Mr. Springer's exit appears amicable and routine based on the company's statement. Financially, Hoth will need to secure additional funding to advance HT-001 through later-stage development, as micro-cap biotechs typically lack substantial revenue streams to self-fund clinical programs.
This positive data point could potentially attract partnership interest from larger pharmaceutical companies marketing EGFR inhibitors, who have vested interests in improving the tolerability of their cancer therapies.
Reports
Open-Label Portion of CLEER HT-001 Phase 2a clinical Trial for Cancer EGFR Inhibitor-
Induced Skin Toxicities
Key Interim Results (Day 1–21):
- Patients experienced a
50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21. - Rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7.
- Some patients achieved complete resolution of pruritus within the 21-day period.
- HT-001 was well tolerated, with no treatment-related serious adverse events reported.
EGFR inhibitors, widely used in oncology, are often associated with skin-related adverse effects, including intense itching, which can impair quality of life and reduce treatment compliance. HT-001 is designed to address this significant unmet need.
Key Interim Results (Day 1–21):
- Patients experienced a
50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21. - Rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7.
- Some patients achieved complete resolution of pruritus within the 21-day period.
- HT-001 was well tolerated, with no treatment-related serious adverse events reported.
"These findings support the potential of HT-001 to deliver meaningful relief for cancer patients experiencing EGFR-related pruritus," said Robb Knie Chief Executive Officer of Hoth Therapeutics. "Cutaneous toxicities can significantly impact quality of life and may interfere with treatment. Our goal is to provide a safe and effective therapy that enhances patient comfort and continuity of care. This data along with our initial results released in January give us further belief in the promise of HT-001."
The CLEER-001 study is ongoing, with both cohorts in effect including the randomized, double-blind portion of the trial.
Hoth would like to thank Mr. Graig Springer who will be leaving our board as his professional position and family life both expand. Mr. Springer has not only been a superb board member, but he has been a great sounding board for the company and we wish Graig much success in all his endeavors.
About HT-001
HT-001 is a proprietary, non-steroidal topical formulation under development for the treatment of pruritus and other inflammatory skin conditions associated with targeted cancer therapies. Designed for localized application, HT-001 aims to alleviate itching and irritation without the systemic side effects of traditional treatments.
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 any 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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SOURCE Hoth Therapeutics, Inc.
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