Medicus Pharma Ltd. Provides Update on United Arab Emirates (UAE) SKNJCT-004 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Medicus Pharma (NASDAQ:MDCX) has initiated patient recruitment for its SKNJCT-004 Phase 2 clinical study at Cleveland Clinic Abu Dhabi (CCAD) to treat Basal Cell Carcinoma (BCC) of the skin. The study will enroll 36 participants across multiple UAE sites in a randomized, double-blind, placebo-controlled trial evaluating two dose levels of D-MNA.
The company's parallel U.S. study, SKNJCT-003, has already enrolled 75% of its 90 targeted participants and showed promising interim results with over 60% clinical clearance. This represents a potential $2 billion market opportunity. Additionally, Medicus recently acquired UK-based Antev Limited and entered a non-binding MoU with Helix Nanotechnologies for potential mRNA platform development.
Medicus Pharma (NASDAQ:MDCX) ha avviato il reclutamento di pazienti per lo studio clinico di Fase 2 SKNJCT-004 presso il Cleveland Clinic Abu Dhabi (CCAD) per il trattamento del carcinoma basocellulare (BCC) della pelle. Lo studio arruolerà 36 partecipanti in più sedi negli Emirati Arabi Uniti in un trial randomizzato, in doppio cieco e controllato con placebo, che valuta due livelli di dose di D-MNA.
Lo studio parallelo dell'azienda negli USA, SKNJCT-003, ha già arruolato il 75% dei 90 partecipanti previsti e ha mostrato risultati intermedi promettenti con oltre il 60% di clearance clinica. Ciò indica un potenziale mercato da 2 miliardi di dollari. Inoltre, Medicus ha recentemente acquisito la britannica Antev Limited e ha siglato un MoU non vincolante con Helix Nanotechnologies per lo sviluppo potenziale di una piattaforma mRNA.
Medicus Pharma (NASDAQ:MDCX) ha iniciado el reclutamiento de pacientes para su estudio clínico de Fase 2 SKNJCT-004 en Cleveland Clinic Abu Dhabi (CCAD) para tratar el carcinoma basocelular (BCC) de la piel. El estudio inscribirá a 36 participantes en varios centros de los EAU en un ensayo aleatorizado, doble ciego y controlado con placebo que evalúa dos niveles de dosis de D-MNA.
El estudio paralelo de la compañía en EE. UU., SKNJCT-003, ya ha inscrito al 75% de los 90 participantes previstos y mostró resultados interinos prometedores con más del 60% de aclaramiento clínico. Esto representa una oportunidad de mercado potencial de 2.000 millones de dólares. Además, Medicus adquirió recientemente la británica Antev Limited y firmó un MoU no vinculante con Helix Nanotechnologies para el posible desarrollo de una plataforma de mRNA.
Medicus Pharma (NASDAQ:MDCX)는 피부 기저세포암(BCC) 치료를 위한 SKNJCT-004 2상 임상시험 환자 모집을 아부다비 클리블랜드 클리닉(CCAD)에서 시작했습니다. 이 연구는 D-MNA의 두 용량 수준을 평가하는 무작위 배정, 이중맹검, 위약 대조 연구로 아랍에미리트 내 여러 기관에서 36명의 참가자를 등록할 예정입니다.
회사의 미국 병행 연구인 SKNJCT-003는 이미 목표 90명 중 75%를 등록했으며 중간 결과에서 60% 이상 임상적 제거율이라는 고무적인 성과를 보였습니다. 이는 잠재적 20억 달러 규모의 시장 기회를 의미합니다. 또한 Medicus는 최근 영국의 Antev Limited를 인수했으며, 잠재적 mRNA 플랫폼 개발을 위해 Helix Nanotechnologies와 비구속적 양해각서(MoU)를 체결했습니다.
Medicus Pharma (NASDAQ:MDCX) a lancé le recrutement de patients pour son essai clinique de phase 2 SKNJCT-004 au Cleveland Clinic Abu Dhabi (CCAD) pour traiter le carcinome basocellulaire (BCC) de la peau. L'étude recrutera 36 participants sur plusieurs sites aux Émirats arabes unis dans un essai randomisé, en double aveugle et contrôlé par placebo, évaluant deux niveaux de dose de D‑MNA.
L'étude parallèle de la société aux États‑Unis, SKNJCT-003, a déjà recruté 75 % des 90 participants ciblés et a montré des résultats intermédiaires prometteurs avec plus de 60 % d_clearance clinique. Cela représente une opportunité de marché potentielle de 2 milliards de dollars. De plus, Medicus a récemment acquis la société britannique Antev Limited et signé un protocole d'accord non contraignant avec Helix Nanotechnologies en vue d'un éventuel développement d'une plateforme d'ARNm.
Medicus Pharma (NASDAQ:MDCX) hat mit der Patientenrekrutierung für die Phase‑2‑Studie SKNJCT-004 am Cleveland Clinic Abu Dhabi (CCAD) zur Behandlung von Basalzellkarzinom (BCC) der Haut begonnen. Die Studie wird in mehreren Standorten der VAE 36 Teilnehmer in einer randomisierten, doppelblinden, placebokontrollierten Studie einschließen und zwei Dosisstufen von D‑MNA untersuchen.
Die parallele US‑Studie des Unternehmens, SKNJCT-003, hat bereits 75% der angestrebten 90 Teilnehmer eingeschlossen und zeigte vielversprechende Zwischenresultate mit über 60% klinischer Clearance. Dies entspricht einer potenziellen Marktchance von 2 Milliarden US‑Dollar. Zusätzlich hat Medicus kürzlich das britische Unternehmen Antev Limited übernommen und ein unverbindliches Memorandum of Understanding mit Helix Nanotechnologies zum möglichen Aufbau einer mRNA‑Plattform unterzeichnet.
- Interim analysis of SKNJCT-003 shows >60% clinical clearance rate
- 75% enrollment completion in U.S. trial with 90 participants
- Potential $2 billion market opportunity identified
- Strategic acquisition of Antev Limited expanding product pipeline
- Study expansion to multiple prestigious UAE medical centers
- MoU with Helix Nanotechnologies is non-binding with no guaranteed outcome
- Interim analysis results may not correlate with final study findings
- Multiple concurrent clinical trials may strain company resources
Insights
Medicus advances BCC treatment trials with UAE patient recruitment progress and promising interim US results showing 60%+ clinical clearance.
Medicus Pharma has reached a significant milestone in its clinical development program for treating basal cell carcinoma (BCC) with the commencement of patient recruitment at Cleveland Clinic Abu Dhabi for its SKNJCT-004 Phase 2 trial. This UAE-based study will evaluate a non-invasive treatment for skin BCC across multiple prestigious medical centers in the region.
The trial design is particularly robust, featuring a randomized, double-blind, placebo-controlled structure with 36 participants across three groups: placebo, low-dose (100μg D-MNA), and high-dose (200μg D-MNA). This methodology will provide comparative efficacy data across different dosing levels against a control group.
What's most encouraging is the parallel progress in their US-based SKNJCT-003 study, which has already shown promising interim results with >60% clinical clearance rate. That study has now randomized over 75% of its expanded 90-participant target, demonstrating strong execution capability.
From an oncology perspective, developing non-invasive alternatives for BCC treatment addresses a significant unmet need. Current standard treatments like surgical excision, while effective, can be disfiguring and problematic for certain anatomical locations. The market opportunity cited (
The company's methodical approach to clinical development, including dose-finding and expansion of trial sites internationally, suggests scientific rigor in their development program. If successful, this could represent a meaningful advancement in dermatological oncology treatment options.
CLEVELAND CLINIC ABU DHABI (CCAD) HAS COMMENCED RECRUITMENT IN THIS 36 PARTICIPANT STUDY
PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / September 8, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, is pleased to announce that the SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin, has commenced patient recruitment in Cleveland clinic Abu Dhabi (CCAD). Earlier this year, in May 2025, SKNJCT-004 received "study may proceed" approval from the UAE Department of Health.
The study is expected to randomize thirty-six (36) patients in four sites in UAE. In addition to Cleveland Clinic Abu Dhabi (CCAD), the study is also expected to commence patient recruitment in Sheikh Shakbout Medical City (SSMC), Burjeel Medical City (BMC), Rashid Hospital (RH), Clemenceau Medical Center (CMC) 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.
"Commencing patient recruitment in the SKNJCT-004 clinical study at Cleveland Clinic Abu Dhabi is a promising step forward towards our goal to bring to market a first in class novel non-invasive alternative to treat BCC ", stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO "We have already randomized more than seventy five percent (
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.
The Company also has the SKNJCT-003 Phase 2 clinical study currently underway in nine (9) clinical sites across United States which commenced randomizing patients in August 2024. In March 2025, the Company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more than
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "MoU") with Helix Nanotechnologies, Inc. ("HelixNano"), a Boston Based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
In August 2025, the Company completed the acquisition of Antev Limited ("Antev"), a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
For further information contact:
Carolyn Bonner, President
(610) 636-0184
cbonner@medicuspharma.com
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicspharma.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. The Company is actively engaged in multiple countries, spread over three continents.
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 a patented dissolvable microneedle patch to deliver a chemotherapeutic agent to eradicate tumors cells. The Company 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 is currently conducting a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-003) in the United States and Europe. The Company has also commenced a randomized, controlled, double-blind, multicenter clinical study (SKNJCT-004) in the United Arab Emirates.
In August 2025, the Company announced its entry into a non-binding memorandum of understanding (the "MoU") with Helix Nanotechnologies, Inc. ("HelixNano"), a Boston Based biotech company focused on developing a proprietary advanced mRNA platform, in respect of their shared mutual interest in the development or commercial arrangement contemplated by the MoU. The MoU is non-binding and shall not be construed to obligate either party to proceed with a joint venture or any further development or commercial arrangement, unless and until definitive agreements are executed.
In August 2025, the Company completed the acquisition of Antev, a UK-based late clinical stage biotech company, developing Teverelix, a next generation GnRH antagonist, as a first in market product for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate.
Antev's flagship drug candidate is Teverelix trifluoroacetate (Teverelix TFA), a long-acting gonadotrophin-releasing hormone (GnRH) antagonist. Unlike GnRH agonists, which can cause an initial surge in testosterone levels, Teverelix directly suppresses sex hormone production without this surge, potentially reducing cardiovascular risks. This mechanism is particularly beneficial for patients with existing cardiovascular conditions. Teverelix is formulated as a microcrystalline suspension, allowing for sustained release and a six-week dosing interval, which may improve patient compliance and outcomes.
In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in fifty (50) patients with advanced prostate cancer (APC), where Teverelix achieved the primary endpoint of greater than
In January 2023, the FDA, reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This milestone supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.
In December 2023, FDA approved the Phase 2b study design in advanced prostate cancer covering 40 patients.
In November 2024, FDA approved the Phase 2b study design in acute urinary retention covering 390 patients.
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 potential benefits of the Antev transaction, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of Teverelix for AURr and high CV risk prostate cancer, and the potential market opportunities related thereto, the MOU, including the potential signing of definitive agreements between Medicus and HelixNano and the development of thermostable infectious diseases vaccines by combining HelixNano's proprietary mRNA vaccine platform with Medicus's proprietary microneedle array (MNA) delivery platform, 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, plans and expectations concerning, and future outcomes relating to, the development, advancement and commercialization of SkinJect through SKNJCT-003 and SKNJCT-004, and the potential market opportunities related thereto, the commencement of the SKNJCT-004 study and the potential results of and benefits of such study. 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", "could," "designed," "would", "should", "estimate", "plan", "project", "forecast", "intend", "expect", "anticipate", "believe", "seek", "continue", "target", "potential" 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 annual report on form 10-K for the year ended December 31, 2024 (the "Annual Report"), and in the Company's other public filings on EDGAR and SEDAR+, 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 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.
SOURCE: Medicus Pharma Ltd
View the original press release on ACCESS Newswire
FAQ
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