Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC)
Medicus Pharma (NASDAQ: MDCX) reports progress in its Phase 2 clinical study (SKNJCT-003) for treating nodular Basal Cell Carcinoma (BCC). The study has successfully randomized over 50% of the planned 60 patients across nine U.S. clinical sites. The company expects to complete interim data analysis by Q1 2025 and plans to submit findings to the FDA for a Type C meeting in Q2 2025.
The study evaluates two dose levels of D-MNA (100μg and 200μg) against placebo in a 1:1:1 randomization. This follows successful Phase 1 results from March 2021, where the treatment showed safety and tolerability with no serious adverse events, and achieved complete responses in 6 participants with nodular BCC.
Medicus Pharma (NASDAQ: MDCX) riporta progressi nel suo studio clinico di Fase 2 (SKNJCT-003) per il trattamento del carcinoma basocellulare nodulare (BCC). Lo studio ha randomizzato con successo oltre il 50% dei 60 pazienti previsti in nove siti clinici negli Stati Uniti. L'azienda prevede di completare l'analisi dei dati intermedi entro il primo trimestre del 2025 e ha in programma di presentare i risultati alla FDA per un incontro di Tipo C nel secondo trimestre del 2025.
Lo studio valuta due livelli di dosaggio di D-MNA (100μg e 200μg) rispetto al placebo in una randomizzazione 1:1:1. Questo segue i risultati positivi della Fase 1 di marzo 2021, dove il trattamento ha mostrato sicurezza e tollerabilità senza eventi avversi gravi, e ha ottenuto risposte complete in 6 partecipanti con BCC nodulare.
Medicus Pharma (NASDAQ: MDCX) informa sobre el progreso en su estudio clínico de Fase 2 (SKNJCT-003) para el tratamiento del carcinoma basocelular nodular (BCC). El estudio ha randomizado con éxito más del 50% de los 60 pacientes planificados en nueve sitios clínicos en EE. UU. La compañía espera completar el análisis de los datos intermedios para el primer trimestre de 2025 y planea presentar los hallazgos a la FDA para una reunión de Tipo C en el segundo trimestre de 2025.
El estudio evalúa dos niveles de dosis de D-MNA (100μg y 200μg) frente al placebo en una randomización 1:1:1. Esto sigue a los resultados exitosos de la Fase 1 de marzo de 2021, donde el tratamiento mostró seguridad y tolerabilidad sin eventos adversos graves, y logró respuestas completas en 6 participantes con BCC nodular.
Medicus Pharma (NASDAQ: MDCX)는 결절성 기저세포암(BCC) 치료를 위한 2상 임상 연구(SKJNCT-003)의 진행 상황을 보고합니다. 이 연구는 미국 9개 임상 사이트에서 계획된 60명의 환자 중 50% 이상을 성공적으로 무작위 배정했습니다. 회사는 2025년 1분기까지 중간 데이터 분석을 완료할 것으로 예상하며, 2025년 2분기에 FDA에 Type C 미팅을 위한 결과를 제출할 계획입니다.
이 연구는 D-MNA의 두 가지 용량 수준(100μg 및 200μg)을 플라시보와 비교하여 1:1:1 무작위 배정으로 평가합니다. 이는 2021년 3월의 1상 결과가 성공적이었던 것에 이어지는 것으로, 치료는 심각한 부작용 없이 안전성과 내약성을 보여주었으며, 결절성 BCC 환자 6명에서 완전 반응을 달성했습니다.
Medicus Pharma (NASDAQ: MDCX) fait état des progrès de son étude clinique de Phase 2 (SKNJCT-003) pour le traitement du carcinome basocellulaire nodulaire (BCC). L'étude a réussi à randomiser plus de 50 % des 60 patients prévus dans neuf sites cliniques aux États-Unis. La société s'attend à terminer l'analyse des données intermédiaires d'ici le premier trimestre 2025 et prévoit de soumettre ses résultats à la FDA pour une réunion de Type C au deuxième trimestre 2025.
L'étude évalue deux niveaux de dose de D-MNA (100μg et 200μg) par rapport à un placebo dans une randomisation 1:1:1. Cela fait suite à des résultats positifs de la Phase 1 en mars 2021, où le traitement a montré sécurité et tolérance sans événements indésirables graves, et a obtenu des réponses complètes chez 6 participants atteints de BCC nodulaire.
Medicus Pharma (NASDAQ: MDCX) berichtet über Fortschritte in seiner Phase-2-Studie (SKNJCT-003) zur Behandlung von nodulärem Basalzellkarzinom (BCC). Die Studie hat erfolgreich über 50% der geplanten 60 Patienten an neun klinischen Standorten in den USA randomisiert. Das Unternehmen erwartet, die Zwischenanalyse der Daten bis zum ersten Quartal 2025 abzuschließen und plant, die Ergebnisse im zweiten Quartal 2025 der FDA für ein Typ-C-Meeting vorzulegen.
Die Studie bewertet zwei Dosisstufen von D-MNA (100μg und 200μg) im Vergleich zu Placebo in einer 1:1:1-Randomisierung. Dies folgt auf die erfolgreichen Ergebnisse der Phase 1 im März 2021, bei denen die Behandlung Sicherheit und Verträglichkeit ohne schwerwiegende unerwünschte Ereignisse zeigte und bei 6 Teilnehmern mit nodulärem BCC vollständige Antworten erzielte.
- Over 50% patient enrollment achieved in Phase 2 clinical trial
- Previous Phase 1 study showed complete response in 6 out of 13 participants
- Phase 1 demonstrated no dose-limiting toxicities or serious adverse events
- Company on track for FDA submission and Type C meeting in Q2 2025
- Small patient sample size (60 patients) in Phase 2 trial
- Results from interim analysis not yet available
Insights
The interim data analysis timeline and 50% enrollment milestone in Medicus Pharma's Phase 2 SKNJCT-003 trial represents a important inflection point for their novel BCC treatment. The previous Phase 1 results showing 6 complete responses with no serious adverse events provides a strong foundation for Phase 2 success, particularly noteworthy given the diverse patient profile and 100% response rate in nodular BCC cases.
The trial design incorporating two dose levels (100μg and 200μg) is strategically important, as it could help establish optimal dosing while potentially demonstrating a dose-dependent response - a key factor for FDA consideration. The selection of the 200μg maximum dose, based on Phase 1 safety data, reflects a conservative approach that balances efficacy with risk management.
The planned Type C meeting with FDA in Q2 2025 is particularly significant as it could accelerate the development timeline. If the interim data is compelling, there's potential to convert this exploratory trial into a pivotal study, which could substantially reduce time to market. The non-invasive microneedle delivery system addresses a critical unmet need in BCC treatment, where current options often involve surgery or topical treatments with efficacy.
From a market perspective, the focus on nodular BCC - one of the more aggressive subtypes - positions the treatment for a significant market opportunity. The dissolvable microneedle patch technology could represent a paradigm shift in skin cancer treatment, offering a more patient-friendly approach compared to traditional surgical excision.
The company is on track to complete the interim data analysis before the end of Q1 2025 and to submit the findings to the U.S. Food And Drug Administration (FDA)
PHILADELPHIA, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is also pleased to announce that its phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States, has now randomized more than
The Company also announced that it is on track to complete an interim data analysis before the end of Q1 2025 and to submit its findings to the United States Food and Drug Administration (FDA) as part of a package seeking a Type C meeting with the FDA in Q2 2025.
The purpose of the Type C meeting is to formally discuss the product development and gain further alignment on the clinical pathway. The Company’s aim is to gain FDA’s consent to fast-track the clinical development program.
Clinical Trial Design
The clinical study, SKNJCT-003, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA.
The high-dose, 200μg D-MNA, proposed in the study is the maximum dose that was used in the Company’s Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021.
SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants (6/6) had nodular subtype of BCC.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jfeffer@lifesciadvisors.com
About Medicus Pharma Ltd:
Medicus Pharma Ltd. (Nasdaq: MDCX) is a biotech/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.
SkinJect Inc. a wholly owned subsidiary of Medicus Pharma Ltd, is a development stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumors cells. The Company has completed a phase 1 safety & tolerability study (SKNJCT-001) in March of 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six (6) participants experiencing complete response on histological examination of the resected lesion. The Company submitted a Phase 2 IND clinical protocol to the FDA in January 2024 for a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) that is expected to randomize up to 60 patients. The study is designed to evaluate the efficacy of two dose levels (100 and 200 ug) of D-MNA compared to placebo (P-MNA) in subjects with nodular BCC. Patient recruitment is currently underway in nine sites across the United States.
Cautionary Notice on Forward-Looking Statements
Certain information in this news release constitutes "forward-looking information" under applicable securities laws. "Forward-looking information" is defined as disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action and includes, without limitation, statements regarding the Company’s plans and expectations concerning, and future outcomes relating to, the submission and advancement of the phase 2 clinical protocol, the randomization of patients and size of the study, the Company’s intention to complete and submit an interim data analysis to the FDA and to request a Type C meeting and the timing thereof, the Company’s aim to fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial, and approval from the FDA and the timing thereof. Forward-looking statements are often but not always, identified by the use of such terms as "may", “on track”, “aim”, "might", "will", "will likely result", "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target" or the negative and/or inverse of such terms or other similar expressions.
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FAQ
What are the key findings from MDCX's Phase 1 trial for BCC treatment?
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