Medicus Pharma Ltd Announces Positively Trending Interim Analysis for SKNJCT-003 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Medicus Pharma (NASDAQ: MDCX) has announced positive interim results from its SKNJCT-003 Phase 2 clinical study for treating basal cell carcinoma (BCC) non-invasively. The study, conducted across 9 U.S. clinical sites with a target of 60 patients, shows over 60% complete clinical clearance in interim analysis.
The trial evaluates two dose levels of D-MNA (100μg and 200μg) against placebo, with patients randomized 1:1:1. Both dose levels demonstrated good tolerability with no dose-limiting toxicities or serious adverse events. The company plans to submit these findings to the FDA and seek a Type C meeting in Q2 2025 to discuss expediting clinical development.
Additionally, Medicus has submitted a clinical design (SKNJCT-004) to UAE's Department of Health, planning to randomize 36 patients across four UAE medical facilities.
Medicus Pharma (NASDAQ: MDCX) ha annunciato risultati intermedi positivi dal suo studio clinico di fase 2 SKNJCT-003 per il trattamento non invasivo del carcinoma basocellulare (BCC). Lo studio, condotto in 9 centri clinici negli Stati Uniti con un obiettivo di 60 pazienti, mostra oltre il 60% di clearance clinica completa nell'analisi intermedia.
Il trial valuta due livelli di dosaggio di D-MNA (100μg e 200μg) contro placebo, con pazienti randomizzati 1:1:1. Entrambi i livelli di dosaggio hanno dimostrato una buona tollerabilità senza tossicità limitanti per il dosaggio o eventi avversi seri. L'azienda prevede di presentare questi risultati alla FDA e richiedere un incontro di Tipo C nel secondo trimestre del 2025 per discutere l'accelerazione dello sviluppo clinico.
Inoltre, Medicus ha presentato un design clinico (SKNJCT-004) al Dipartimento della Salute degli Emirati Arabi Uniti, pianificando di randomizzare 36 pazienti in quattro strutture mediche degli EAU.
Medicus Pharma (NASDAQ: MDCX) ha anunciado resultados intermedios positivos de su estudio clínico de fase 2 SKNJCT-003 para el tratamiento no invasivo del carcinoma basocelular (BCC). El estudio, realizado en 9 sitios clínicos en EE. UU. con un objetivo de 60 pacientes, muestra más del 60% de aclaramiento clínico completo en el análisis intermedio.
El ensayo evalúa dos niveles de dosis de D-MNA (100μg y 200μg) frente a placebo, con pacientes aleatorizados 1:1:1. Ambos niveles de dosis demostraron buena tolerancia sin toxicidades limitantes de dosis ni eventos adversos graves. La compañía planea presentar estos hallazgos a la FDA y solicitar una reunión de Tipo C en el segundo trimestre de 2025 para discutir la aceleración del desarrollo clínico.
Además, Medicus ha presentado un diseño clínico (SKNJCT-004) al Departamento de Salud de los EAU, planeando aleatorizar a 36 pacientes en cuatro instalaciones médicas de los EAU.
메디쿠스 제약 (NASDAQ: MDCX)는 비침습적으로 기저세포암(BCC)을 치료하기 위한 SKNJCT-003 2상 임상 연구의 긍정적인 중간 결과를 발표했습니다. 이 연구는 60명의 환자를 목표로 하여 미국의 9개 임상 사이트에서 수행되었으며, 중간 분석에서 60% 이상의 완전한 임상적 제거를 보여줍니다.
시험은 D-MNA의 두 가지 용량 수준(100μg 및 200μg)을 대조군과 비교하며, 환자는 1:1:1로 무작위 배정됩니다. 두 용량 수준 모두 용량 제한 독성이나 심각한 이상 반응 없이 좋은 내약성을 보여주었습니다. 회사는 이러한 결과를 FDA에 제출하고 2025년 2분기에 임상 개발 가속화를 논의하기 위한 Type C 회의를 요청할 계획입니다.
추가로, 메디쿠스는 UAE 보건부에 임상 설계(SKNJCT-004)를 제출했으며, UAE의 네 개 의료 시설에서 36명의 환자를 무작위 배정할 계획입니다.
Medicus Pharma (NASDAQ: MDCX) a annoncé des résultats intermédiaires positifs de son étude clinique de phase 2 SKNJCT-003 pour le traitement non invasif du carcinome basocellulaire (BCC). L'étude, réalisée sur 9 sites cliniques aux États-Unis avec un objectif de 60 patients, montre plus de 60 % de clairance clinique complète dans l'analyse intermédiaire.
L'essai évalue deux niveaux de dose de D-MNA (100μg et 200μg) par rapport à un placebo, les patients étant randomisés dans un rapport de 1:1:1. Les deux niveaux de dose ont montré une bonne tolérance sans toxicités limitantes de dose ni événements indésirables graves. La société prévoit de soumettre ces résultats à la FDA et de demander une réunion de type C au deuxième trimestre 2025 pour discuter de l'accélération du développement clinique.
De plus, Medicus a soumis un design clinique (SKNJCT-004) au ministère de la Santé des Émirats Arabes Unis, prévoyant de randomiser 36 patients dans quatre établissements médicaux des EAU.
Medicus Pharma (NASDAQ: MDCX) hat positive Zwischenresultate aus seiner Phase-2-Studie SKNJCT-003 zur nicht-invasiven Behandlung von Basalzellkarzinomen (BCC) bekannt gegeben. Die Studie, die an 9 klinischen Standorten in den USA mit einem Ziel von 60 Patienten durchgeführt wurde, zeigt über 60% vollständige klinische Clearance in der Zwischenanalyse.
Die Studie bewertet zwei Dosisstufen von D-MNA (100μg und 200μg) im Vergleich zu Placebo, wobei die Patienten im Verhältnis 1:1:1 randomisiert wurden. Beide Dosisstufen zeigten eine gute Verträglichkeit ohne dosislimitierende Toxizität oder schwerwiegende unerwünschte Ereignisse. Das Unternehmen plant, diese Ergebnisse der FDA vorzulegen und im zweiten Quartal 2025 ein Type-C-Meeting zu beantragen, um die Beschleunigung der klinischen Entwicklung zu besprechen.
Zusätzlich hat Medicus ein klinisches Design (SKNJCT-004) beim Gesundheitsministerium der VAE eingereicht und plant, 36 Patienten in vier medizinischen Einrichtungen in den VAE zu randomisieren.
- 60% complete clinical clearance rate in interim analysis
- No dose-limiting toxicities or serious adverse events reported
- Study expanding internationally with UAE clinical sites
- Previous Phase 1 showed complete response in 6 participants
- Interim results may not correlate with final study findings
- Still requires FDA approval for fast-track development
Insights
The interim Phase 2 results for Medicus Pharma's dissolvable microneedle patch (D-MNA) represent a potentially significant advancement in non-invasive basal cell carcinoma treatment. A
What makes this particularly interesting is the safety profile - no dose-limiting toxicities or serious adverse events at either the 100μg or 200μg dose levels. This favorable tolerability, combined with the non-invasive delivery mechanism, addresses a genuine unmet need for patients seeking alternatives to surgery, particularly for cosmetically sensitive areas.
The study design is methodologically sound: randomized, double-blind, placebo-controlled across multiple centers with appropriate dose comparison groups. The company's previous Phase 1 study demonstrated both safety and preliminary efficacy signals with 6 complete responses, suggesting consistency in outcomes.
The planned FDA Type C meeting represents a logical regulatory step, though "fast-tracking" would require demonstration of significant advantages over existing treatments or addressing an unmet medical need. While surgical approaches remain the gold standard for efficacy, this non-invasive alternative could find substantial clinical utility among patients reluctant to undergo surgery or with multiple or recurrent lesions.
These interim Phase 2 results significantly de-risk Medicus Pharma's lead clinical program in basal cell carcinoma. For a
The
The company's dual-geography strategy (US and UAE clinical sites) demonstrates regulatory sophistication and could accelerate time-to-market. The planned FDA Type C meeting in Q2 2025 to discuss potential development acceleration represents a near-term catalyst, though investors should note that accelerated pathways are never guaranteed.
The clean safety profile across both dose levels substantially reduces clinical development risk. With the Phase 1 already showing complete responses in 6 participants and this larger dataset trending positively, the probability of technical success has meaningfully improved.
For non-invasive treatment of the common cancer BCC, market potential is substantial. Should the final data package confirm these interim results, Medicus would have a differentiated product addressing a large market with non-invasive competitors, potentially supporting significant valuation re-rating.
The Interim Analysis Showed Complete Clinical Clearance of More Than Sixty (
PHILADELPHIA, March 06, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce a positively trending interim analysis for SKNJCT-003 Phase 2 clinical study to non-invasively treat basal cell carcinoma of the skin (BCC).
The SKNJCT-003 clinical study is currently underway in nine (9) clinical sites in United States and is expected to randomize 60 patients. The interim analysis was conducted after more than
The interim analysis shows the clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than
The Company plans to submit the interim analysis 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.
“We are immensely encouraged by the positively trending interim analysis”, stated Dr. Raza Bokhari, Executive Chairman & CEO. “The interim analysis brings us one step closer to delivering a novel, non-invasive treatment for BCC”.
Clinical Trial Design
The clinical study 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 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.
The Company also has submitted a clinical design (SKNJCT-004) to United Arab Emirates (UAE) Department of Health (DOH). The study is expected to randomize 36 patients in four sites in UAE, which are Cleveland Clinic Abu Dhabi (CCAD), Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), and American Hospital of Dubai (AHD).
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 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 results of the interim analysis, which may or may not correlate with the findings of the clinical study report that will be compiled following completion of the phase 2 study, 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 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.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including those risk factors described in the Company's public filings on SEDAR+ and on EDGAR, which may impact, among other things, the trading price and liquidity of the Company's common shares. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect our expectations as of the date hereof, and thus are subject to change thereafter. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Readers are cautioned that the foregoing list is not exhaustive and readers are encouraged to review the Company’s long form prospectus accessible on the Company's profile on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Readers are further cautioned not to place undue reliance on forward-looking statements as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
FAQ
What are the interim results of MDCX's Phase 2 BCC treatment study?
How many patients are enrolled in MDCX's SKNJCT-003 Phase 2 trial?
When will MDCX meet with the FDA regarding their BCC treatment?
What are the dosage levels being tested in MDCX's Phase 2 BCC study?
Is MDCX expanding their BCC treatment trials internationally?
