Medicus Pharma Ltd. Announces First Patient Treated in United Arab Emirates (UAE) Sknjct-004 Phase 2 Clinical Study to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin
Medicus Pharma (NASDAQ:MDCX) announced the first patient enrolled in the UAE for its SKNJCT-004 Phase 2 randomized, double-blind, placebo-controlled study to non-invasively treat basal cell carcinoma (BCC) using dissolvable Doxorubicin-containing microneedle arrays (D-MNA).
The 36-subject UAE study will run across six sites including Cleveland Clinic Abu Dhabi and is coordinated by IROS. Medicus also reported ongoing U.S. Phase 2 SKNJCT-003 with a March 2025 interim showing >60% clinical clearance and FDA Type C feedback supporting a 505(b)(2) pathway. In August 2025 Medicus completed acquisition of Antev, adding Teverelix TFA for advanced prostate cancer.
Medicus Pharma (NASDAQ:MDCX) ha annunciato il primo paziente arruolato negli UAE per lo studio randomizzato di fase 2 in cieco doppio, controllato da placebo SKNJCT-004 volto a trattare non invasivamente il carcinoma basocellulare (BCC) utilizzando array di microinnesti dissolvibili contenenti doxorubicina (D-MNA).
Lo studio UAE con 36 soggetti si svolgerà in sei centri tra cui la Cleveland Clinic Abu Dhabi ed è coordinato da IROS. Medicus ha riportato anche lo stato di avanzamento della fase 2 statunitense SKNJCT-003 con un interim di marzo 2025 che mostra >60% di clearing clinico e feedback della FDA tipo C a supporto di una via 505(b)(2). Nell'agosto 2025 Medicus ha completato l'acquisizione di Antev, aggiungendo Teverelix TFA per il cancro della prostata avanzato.
Medicus Pharma (NASDAQ:MDCX) anunció el primer paciente inscrito en los EAU para su estudio aleatorizado, doble ciego, controlado con placebo de fase 2 SKNJCT-004 para tratar no invasivamente el carcinoma de células basales (BCC) utilizando matrices de microagujas disolubles que contienen doxorubicina (D-MNA).
El estudio en los EAU con 36 sujetos se realizará en seis sitios, incluyendo la Cleveland Clinic Abu Dhabi, y está coordinado por IROS. Medicus también informó sobre la fase 2 en EE. UU. SKNJCT-003 con una interim de marzo de 2025 que muestra >60% de aclaramiento clínico y comentarios de la FDA tipo C que respaldan una vía 505(b)(2). En agosto de 2025, Medicus completó la adquisición de Antev, añadiendo Teverelix TFA para el cáncer de próstata avanzado.
Medicus Pharma (NASDAQ:MDCX)는 UAE에서의 2상 무작위 이중맹검, 위약 대조 연구 SKNJCT-004의 첫 환자 등록을 발표했습니다. 이는 용해 가능한 다소로루비시산(Doxorubicin) 함유 마이크로니들 어레이(D-MNA)를 사용하여 피부 비침습적으로 기저세포암(BCC)을 치료합니다.
36명의 피험자를 대상으로 하는 UAE 연구는 클리블랜드 클리닉 아부다비를 포함한 6개 사이트에서 진행되며 IROS가 조정합니다. Medicus는 또한 미국에서의 2상 SKNJCT-003의 진행 상황을 보고했으며 2025년 3월 중간 결과에서 임상적 제거율이 60%를 초과했고 FDA 유형 C 피드백이 505(b)(2) 경로를 뒷받침합니다. 2025년 8월 Medicus는 Antev를 인수하여 전진성 전립선암 치료에 Teverelix TFA를 추가했습니다.
Medicus Pharma (NASDAQ:MDCX) a annoncé le premier patient enrôlé aux Émirats Arabes Unis pour son étude de phase 2 randomisée, en double aveugle et contrôlée par placebo SKNJCT-004 visant à traiter non invasivement le carcinome basocellulaire (BCC) à l'aide de réseaux de micro-aiguilles dissolvables contenant de la doxorubicine (D-MNA).
L'étude UAE avec 36 sujets se déroulera sur six sites, dont la Cleveland Clinic Abu Dhabi, et est coordonnée par IROS. Medicus a également signalé l'état d'avancement de la phase 2 américaine SKNJCT-003 avec un intermédiaire de mars 2025 montrant >60% de clairance clinique et des retours de la FDA de type C soutenant une voie 505(b)(2). En août 2025, Medicus a terminé l'acquisition d'Antev, ajoutant Teverelix TFA pour le cancer de la prostate avancé.
Medicus Pharma (NASDAQ:MDCX) gab den ersten eingeschriebenen Patienten in den VAE für seine randomisierte, doppelblinde, placebokontrollierte Phase-2-Studie SKNJCT-004 bekannt, um basaliom (BCC) nicht invasiv mittels löslicher Doxorubicin-haltiger Mikronadeln (D-MNA) zu behandeln.
Die UAE-Studie mit 36 Probanden wird an sechs Standorten, darunter die Cleveland Clinic Abu Dhabi, durchgeführt und von IROS koordiniert. Medicus berichtete auch über den laufenden US-Phase-2-Studienstand SKNJCT-003 mit einem Zwischenbericht von März 2025, der eine >60% klinische Clearance zeigt, und FDA Type-C-Feedback, das einen 505(b)(2)-Weg unterstützt. Im August 2025 hat Medicus die Übernahme von Antev abgeschlossen und Teverelix TFA für fortgeschrittenen Prostatakrebs hinzugefügt.
Medicus Pharma (NASDAQ:MDCX) أعلنت عن تسجيل أول مريض في الإمارات العربية المتحدة لدراستها من المرحلة الثانية العشوائية والمزدوجة التعمية والتي تتحكم فيها الدواء بالدواء الوهمي SKNJCT-004 لعلاج سرطان الخلايا الجلدية القاعدية(BCC) بشكل غير جراحي باستخدام صفائف ميكرونيدلز قابلة للذوبان تحتوي على دوكسوروبيسين (D-MNA).
ستنفذ الدراسة الإماراتية في 36 مشاركًا في ستة مواقع بما في ذلك كليفلاند كلينك أبوظبي وتتم تنسيقها من قبل IROS. كما أبلغت Medicus عن المرحلة الثانية الأمريكية SKNJCT-003 مع عرض وسيط في مارس 2025 يظهر أكثر من 60% إزالة مرضية ودعم من FDA بتغذية Type C تدعم مسار 505(b)(2). في أغسطس 2025 أكملت Medicus الاستحواذ على Antev، مضيفة Teverelix TFA لسرطان البروستاتا المتقدم.
Medicus Pharma (NASDAQ:MDCX) 宣布在阿联酋招募的首例患者参与其 SKNJCT-004 第2期随机、双盲、安慰剂对照研究，利用可溶解的含阿霉素微针阵列(D-MNA)非侵入性治疗基底细胞癌(BCC)。
这项在阿联酔的36名受试者研究将在六个地点进行，包括阿布扎比克利夫兰诊所，由IROS协调。Medicus还报告了美国第2期SKNJCT-003的进展情况，2025年3月的中期显示临床清除率>60%，FDA类型C反馈支持505(b)(2)途径。2025年8月，Medicus完成对Antev的收购，新增Teverelix TFA用于晚期前列腺癌。
- SKNJCT-003 interim >60% clinical clearance (March 2025)
- FDA Type C feedback supports 505(b)(2) pathway
- UAE SKNJCT-004 launched with 36 planned subjects
- Acquisition of Antev completed (August 2025)
- SKNJCT-003 interim findings are preliminary and not definitive
- SKNJCT-004 small 36-patient size limits statistical power
- Regulatory feedback is guidance, not marketing approval
Insights
Enrollment in UAE Phase 2, positive interim signals and FDA Type C feedback collectively advance clinical and regulatory pathways for Skinject.
The study expands randomized Phase 2 testing of dissolvable D-MNA for basal cell carcinoma to six UAE sites with the first patient treated at Cleveland Clinic Abu Dhabi, increasing geographic diversity and patient access while keeping the original 1:1:1 three-arm design (placebo, 100μg, 200μg). The program now runs parallel SKNJCT-003 (U.S.) and SKNJCT-004 (UAE) trials and follows a Phase 1 maximum dose of
Key dependencies and risks include enrollment pace across six UAE centers, the preliminary nature of the interim >
Watch for final efficacy and safety readouts from SKNJCT-003 and SKNJCT-004, formal FDA guidance or agreement on the 505(b)(2) plan, and enrollment milestones over the next 6–18 months; the SKNJCT-003 expansion to 90 subjects and >75% randomization progress provide near-term signals (
CLEVELAND CLINIC ABU DHABI (CCAD) IS THE PRINCIPAL INVESTIGATOR IN THIS 36 PARTICIPANT STUDY
PHILADELPHIA, PA / ACCESS Newswire / October 22, 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 the enrollment of the first patient in United Arab Emirates (UAE) SKNJCT-004 phase 2 clinical study, to non-invasively treat BCC of the skin.
The study is expected to randomize thirty-six (36) patients in six 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.
"Treating our first BCC patient at Cleveland Clinic Abu Dhabi is an important milestone in expanding our clinical study beyond the shores of United States", stated Dr. Raza Bokhari, Medicus's Executive Chairman & CEO "Non melanoma Skin diseases, especially BCC is not just an American problem but a global challenge which we believe represents more than US
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 is also conducting a Phase 2 clinical study for SKNJCT-003 in nine (9) clinical sites across the United States which commenced randomizing patients in August 2024. SKNJCT-003 is a double blinded, placebo controlled triple arm proof of concept Phase 2 clinical study, designed to non-invasively treat basal cell carcinoma (BCC) of the skin using novel, patent protected, dissolvable Doxorubicin-containing microneedle arrays (D-MNA). In March 2025, the Company announced a positively trending interim analysis for SKNJCT-003 demonstrating more than
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.
For further information contact:
Carolyn Bonner, President and Acting Chief Financial Officer
(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 potentially 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, the development of Teverelix 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 advancement 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
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FAQ
What is Medicus Pharma (MDCX) announcing on October 22, 2025?
How large is the SKNJCT-004 trial for MDCX and where will it run?
What did the interim analysis for MDCX SKNJCT-003 show and when?
Did the FDA give any guidance to Medicus (MDCX) about the Skinject program?
What strategic acquisition did Medicus complete in August 2025?
Who is coordinating the UAE SKNJCT-004 study for MDCX?
