Medicus Pharma Ltd Announces Submission of Phase 2 Clinical Design (SKNJCT-004) to United Arab Emirates (UAE) Department of Health (DOH) to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Medicus Pharma (NASDAQ: MDCX) has submitted a Phase 2 clinical design (SKNJCT-004) to UAE's Department of Health for non-invasive treatment of Basal Cell Carcinoma (BCC). The study will randomize 36 patients across four UAE clinical sites, testing two dose levels of D-MNA against placebo.
The trial follows successful Phase 1 results (SKNJCT-001) completed in March 2021, which demonstrated safety and tolerability with no serious adverse events across all dose levels. Notably, 6 participants showed complete responses in treating nodular BCC.
Additionally, Medicus has a parallel Phase 2 study (SKNJCT-003) ongoing in the US across 9 clinical sites, targeting 60 patients, with over 50% already randomized. The company plans an interim data analysis in Q1 2025 and aims to seek FDA's consent for fast-tracking the clinical development program through a Type C meeting in Q2 2025.
Medicus Pharma (NASDAQ: MDCX) ha presentato un progetto clinico di Fase 2 (SKNJCT-004) al Dipartimento della Salute degli Emirati Arabi Uniti per un trattamento non invasivo del Carcinoma Basocellulare (BCC). Lo studio randomizzerà 36 pazienti in quattro centri clinici degli Emirati, testando due livelli di dose di D-MNA rispetto al placebo.
Il trial segue i risultati positivi della Fase 1 (SKNJCT-001) completati a marzo 2021, che hanno dimostrato sicurezza e tollerabilità senza eventi avversi gravi a tutti i livelli di dose. In particolare, 6 partecipanti hanno mostrato risposte complete nel trattamento del BCC nodulare.
Inoltre, Medicus ha uno studio parallelo di Fase 2 (SKNJCT-003) in corso negli Stati Uniti in 9 centri clinici, che mira a 60 pazienti, con oltre il 50% già randomizzati. L'azienda prevede un'analisi intermedia dei dati nel primo trimestre del 2025 e intende richiedere il consenso della FDA per accelerare il programma di sviluppo clinico attraverso un incontro di Tipo C nel secondo trimestre del 2025.
Medicus Pharma (NASDAQ: MDCX) ha presentado un diseño clínico de Fase 2 (SKNJCT-004) al Departamento de Salud de los EAU para un tratamiento no invasivo del Carcinoma Basocelular (BCC). El estudio aleatorizará a 36 pacientes en cuatro sitios clínicos de los EAU, probando dos niveles de dosis de D-MNA frente a un placebo.
El ensayo sigue los resultados exitosos de la Fase 1 (SKNJCT-001) completados en marzo de 2021, que demostraron seguridad y tolerabilidad sin eventos adversos graves en todos los niveles de dosis. Notablemente, 6 participantes mostraron respuestas completas en el tratamiento del BCC nodular.
Además, Medicus tiene un estudio paralelo de Fase 2 (SKNJCT-003) en curso en EE. UU. en 9 sitios clínicos, con un objetivo de 60 pacientes, de los cuales más del 50% ya han sido aleatorizados. La compañía planea realizar un análisis intermedio de datos en el primer trimestre de 2025 y espera solicitar el consentimiento de la FDA para acelerar el programa de desarrollo clínico a través de una reunión de Tipo C en el segundo trimestre de 2025.
Medicus Pharma (NASDAQ: MDCX)는 UAE 보건부에 비침습적 기저세포암(BCC) 치료를 위한 2상 임상 설계(SKNJCT-004)를 제출했습니다. 이 연구는 UAE의 4개 임상 사이트에서 36명의 환자를 무작위 배정하여 D-MNA의 두 가지 용량 수준을 위약과 비교합니다.
이 시험은 2021년 3월에 완료된 1상 결과(SKNJCT-001)를 따르며, 모든 용량 수준에서 심각한 부작용 없이 안전성과 내약성을 입증했습니다. 특히, 6명의 참가자가 결절성 BCC 치료에서 완전 반응을 보였습니다.
또한, Medicus는 미국에서 9개 임상 사이트에서 60명의 환자를 대상으로 하는 2상 연구(SKNJCT-003)를 진행 중이며, 이미 50% 이상이 무작위 배정되었습니다. 이 회사는 2025년 1분기에 중간 데이터 분석을 계획하고 있으며, 2025년 2분기에 FDA의 빠른 임상 개발 프로그램 승인을 요청할 예정입니다.
Medicus Pharma (NASDAQ: MDCX) a soumis un design clinique de Phase 2 (SKNJCT-004) au Département de la Santé des Émirats Arabes Unis pour un traitement non invasif du Carcinome Basocellulaire (BCC). L'étude randomisera 36 patients à travers quatre sites cliniques aux Émirats, testant deux niveaux de dose de D-MNA par rapport à un placebo.
L'essai suit les résultats positifs de la Phase 1 (SKNJCT-001) complétés en mars 2021, qui ont démontré la sécurité et la tolérance sans événements indésirables graves à tous les niveaux de dose. Notamment, 6 participants ont montré des réponses complètes dans le traitement du BCC nodulaire.
De plus, Medicus a une étude parallèle de Phase 2 (SKNJCT-003) en cours aux États-Unis dans 9 sites cliniques, ciblant 60 patients, dont plus de 50% ont déjà été randomisés. L'entreprise prévoit une analyse intermédiaire des données au premier trimestre 2025 et vise à demander le consentement de la FDA pour accélérer le programme de développement clinique lors d'une réunion de Type C au deuxième trimestre 2025.
Medicus Pharma (NASDAQ: MDCX) hat ein klinisches Design der Phase 2 (SKNJCT-004) beim Gesundheitsministerium der VAE für eine nicht-invasive Behandlung des Basalzellkarzinoms (BCC) eingereicht. Die Studie wird 36 Patienten an vier klinischen Standorten in den VAE randomisieren und zwei Dosierungsstufen von D-MNA gegen ein Placebo testen.
Die Studie folgt auf die erfolgreichen Ergebnisse der Phase 1 (SKNJCT-001), die im März 2021 abgeschlossen wurden und Sicherheit sowie Verträglichkeit ohne schwerwiegende unerwünschte Ereignisse auf allen Dosierungsstufen zeigten. Bemerkenswerterweise zeigten 6 Teilnehmer vollständige Reaktionen bei der Behandlung von nodulärem BCC.
Zusätzlich führt Medicus eine parallele Phase-2-Studie (SKNJCT-003) in den USA an 9 klinischen Standorten durch, die 60 Patienten anvisiert, von denen bereits über 50% randomisiert wurden. Das Unternehmen plant eine Zwischenanalyse der Daten im ersten Quartal 2025 und beabsichtigt, die FDA um Zustimmung zur beschleunigten klinischen Entwicklung durch ein Typ-C-Meeting im zweiten Quartal 2025 zu bitten.
- Phase 1 trial showed 100% safety profile with no serious adverse events
- 46% efficacy rate in Phase 1 with 6 complete responses
- Over 50% patient recruitment completed in US Phase 2 trial
- Geographic expansion of clinical trials to UAE market
- Small patient sample size (36) in UAE Phase 2 trial
- Still in early clinical development phase
- Multiple competing trials may extend development timeline
Insights
Medicus Pharma's submission of a second Phase 2 clinical trial design to the UAE Department of Health represents a strategic expansion of their development program for basal cell carcinoma (BCC). This parallel trial approach—running studies simultaneously in the US and UAE—could potentially accelerate their regulatory pathway while generating complementary datasets across diverse patient populations.
The company's SKNJCT-004 UAE trial mirrors their ongoing US study with a three-arm design (placebo, 100μg, and 200μg doses), suggesting confidence in their protocol based on promising Phase 1 results where 6 patients showed complete histological clearance of nodular BCC tumors. With over 50% of patients already enrolled in their US trial and interim analysis expected by Q1 2025, Medicus is positioning for a critical FDA Type C meeting that could potentially streamline their development timeline.
The market opportunity is substantial—BCC affects millions of patients annually as the world's most common cancer. Current standard treatments are primarily surgical, often resulting in scarring and recurrence rates of 5-10%. A non-invasive alternative using dissolvable microneedle technology represents a potentially disruptive approach to this
For investors, several key milestones warrant attention: the upcoming interim analysis, FDA Type C meeting outcome in Q2 2025, and enrollment progress in both trials. With a modest
Medicus Pharma's expansion of their BCC clinical program to the UAE represents a significant advancement in non-invasive skin cancer treatment. Their dissolvable microneedle technology (D-MNA) delivers chemotherapeutic agents precisely to tumor sites with minimal surrounding tissue exposure—a important advantage over conventional topical applications that struggle with drug penetration through the skin barrier.
The Phase 1 results showing complete histological clearance in 6 patients with nodular BCC is particularly noteworthy. Nodular BCC, representing 60-80% of all cases, is characterized by well-circumscribed tumor nests extending into the dermis, making it an ideal candidate for this microneedle approach. The absence of dose-limiting toxicities across all treatment levels suggests a favorable safety profile compared to existing non-surgical alternatives like imiquimod (which causes significant inflammation) or photodynamic therapy (associated with considerable pain).
The parallel Phase 2 trials in both the US and UAE will likely assess not only tumor clearance rates but also cosmetic outcomes—a critical consideration as current surgical approaches often result in visible scarring, particularly in cosmetically sensitive areas like the face where over 80% of BCCs occur. The randomized, placebo-controlled design with two dose levels will help establish the optimal therapeutic regimen.
For patients, a non-invasive treatment that preserves normal tissue architecture would represent a paradigm shift in BCC management. Current surgical approaches (Mohs, excision, curettage) all disrupt tissue integrity and require healing periods. While this technology shows promise for superficial and nodular subtypes, more aggressive infiltrative variants would likely still require surgical intervention.
The interim analysis of the US trial expected in Q1 2025 will provide important efficacy signals that could significantly impact the development trajectory. If positive, this technology could potentially address the estimated 3.6 million cases of BCC diagnosed annually in the US alone, though long-term recurrence rates will ultimately determine its position in the treatment algorithm.
The Clinical Study is Expected to Randomize 36 Participants in Cleveland Clinic Abu Dhabi (CCAD) and Three Other Clinical Sites in UAE
PHILADELPHIA, Feb. 27, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce that it has submitted a clinical design (SKNJCT-004) to UAE DOH to non-invasively treat BCC of the skin.
The study is expected to randomize thirty-six (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).
Insights Research Organization and Solutions (IROS), a UAE-based contract research organization, is coordinating the clinical study for the Company. IROS is a M42 portfolio company.
Clinical Trial Design (SKNJCT-004)
The clinical study, SKNJCT-004, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 36 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 SKNJCT-003 Phase 2 clinical study currently underway in 9 clinical sites in the United States, which is expected to randomize 60 patients. The patient recruitment in this study, which began in August 2024, has now randomized more than
“We are making substantial progress in expanding the clinical development program of our novel non-invasive treatment to cure the most common cancer in the world, beyond the shores of United States,” stated Dr. Raza Bokhari, Executive Chairman & CEO. “UAE is rapidly emerging as a significant hub for Pharmaceutical R&D, driven by strategic investments, public-private partnerships and a commitment to innovation. A clinical study in the Middle East will help us gather useful efficacy and safety data. It will also help us strengthen our clinical development program, as we aspire to bring to market not only the first-in-class, but also the best-in-class, novel non-invasive treatment regimen for 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 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 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
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