Medicus Pharma Provides Update on SKNJCT-003 Phase 2 Clinical Study for the Treatment of Nodular Basal Cell Carcinoma (BCC)
Medicus Pharma (NASDAQ: MDCX) announces significant expansion of its Phase 2 clinical study (SKNJCT-003) for treating nodular Basal Cell Carcinoma (BCC). The Institutional Review Board has approved increasing patient enrollment from 60 to 90 participants. The study, currently active in nine U.S. clinical sites, will expand to additional U.S. locations and two European sites.
The trial has already randomized more than 45 participants, with interim analysis showing promising results: over 60% complete clinical clearance rate. The study evaluates two dose levels of D-MNA (100μg and 200μg) against placebo, with both doses demonstrating good tolerability with no serious adverse events or dose-limiting toxicities.
The company plans to submit a Type C meeting request to the FDA before Q2 2025 end. Additionally, Medicus is pursuing global validation with pending approval in Abu Dhabi and potential collaboration in the Asia-Pacific region.
Medicus Pharma (NASDAQ: MDCX) annuncia un'importante espansione del suo studio clinico di Fase 2 (SKNJCT-003) per il trattamento del carcinoma basocellulare nodulare (BCC). Il Comitato Etico ha approvato l'aumento del numero di pazienti da 60 a 90 partecipanti. Lo studio, attualmente attivo in nove centri clinici negli Stati Uniti, si estenderà a ulteriori sedi negli USA e a due centri in Europa.
Il trial ha già randomizzato oltre 45 partecipanti e l'analisi intermedia mostra risultati promettenti: oltre il 60% di clearance clinica completa. Lo studio valuta due dosi di D-MNA (100μg e 200μg) rispetto al placebo, con entrambe le dosi che hanno dimostrato buona tollerabilità, senza eventi avversi gravi né tossicità limitante la dose.
L'azienda prevede di presentare una richiesta di incontro di tipo C alla FDA entro la fine del secondo trimestre 2025. Inoltre, Medicus sta perseguendo una convalida globale con approvazione in attesa ad Abu Dhabi e una possibile collaborazione nella regione Asia-Pacifico.
Medicus Pharma (NASDAQ: MDCX) anuncia una expansión significativa de su estudio clínico de Fase 2 (SKNJCT-003) para el tratamiento del carcinoma basocelular nodular (BCC). La Junta de Revisión Institucional ha aprobado aumentar la inscripción de pacientes de 60 a 90 participantes. El estudio, actualmente activo en nueve sitios clínicos en EE.UU., se ampliará a más ubicaciones en EE.UU. y a dos sitios en Europa.
El ensayo ya ha aleatorizado a más de 45 participantes, con un análisis intermedio que muestra resultados prometedores: más del 60% de tasa de aclaramiento clínico completo. El estudio evalúa dos niveles de dosis de D-MNA (100μg y 200μg) frente a placebo, con ambas dosis mostrando buena tolerabilidad sin eventos adversos graves ni toxicidades que limiten la dosis.
La compañía planea presentar una solicitud de reunión Tipo C a la FDA antes de finales del segundo trimestre de 2025. Además, Medicus busca la validación global con aprobación pendiente en Abu Dhabi y posible colaboración en la región Asia-Pacífico.
Medicus Pharma (NASDAQ: MDCX)는 결절성 기저세포암(BCC) 치료를 위한 2상 임상시험(SKNJCT-003)의 대규모 확장을 발표했습니다. 기관심사위원회(IRB)는 환자 등록 수를 60명에서 90명으로 늘리는 것을 승인했습니다. 현재 미국 내 9개 임상시험 기관에서 진행 중인 이 연구는 미국 내 추가 장소와 유럽 2개 기관으로 확대될 예정입니다.
임상시험은 이미 45명 이상의 참가자를 무작위 배정했으며, 중간 분석 결과 60% 이상의 완전 임상 관해율이라는 유망한 결과를 보였습니다. 이 연구는 D-MNA 100μg 및 200μg 두 가지 용량을 위약과 비교 평가하며, 두 용량 모두 심각한 부작용이나 용량 제한 독성 없이 우수한 내약성을 나타냈습니다.
회사는 2025년 2분기 말 이전에 FDA에 Type C 미팅 요청을 제출할 계획입니다. 또한 Medicus는 아부다비에서 승인 대기 중이며 아시아-태평양 지역과의 잠재적 협력을 통해 글로벌 검증을 추진하고 있습니다.
Medicus Pharma (NASDAQ : MDCX) annonce une expansion significative de son étude clinique de phase 2 (SKNJCT-003) pour le traitement du carcinome basocellulaire nodulaire (BCC). Le comité d'éthique institutionnel a approuvé l'augmentation du nombre de patients inscrits de 60 à 90 participants. L'étude, actuellement active dans neuf centres cliniques aux États-Unis, s'étendra à d'autres sites américains ainsi qu'à deux sites européens.
L'essai a déjà randomisé plus de 45 participants, avec une analyse intermédiaire montrant des résultats prometteurs : un taux de clairance clinique complète supérieur à 60 %. L'étude évalue deux doses de D-MNA (100μg et 200μg) par rapport au placebo, les deux doses ayant démontré une bonne tolérance sans événements indésirables graves ni toxicités limitant la dose.
La société prévoit de soumettre une demande de réunion de type C à la FDA avant la fin du deuxième trimestre 2025. Par ailleurs, Medicus poursuit une validation mondiale avec une approbation en attente à Abu Dhabi et une collaboration potentielle dans la région Asie-Pacifique.
Medicus Pharma (NASDAQ: MDCX) kündigt eine bedeutende Erweiterung seiner Phase-2-Studie (SKNJCT-003) zur Behandlung des nodulären Basalzellkarzinoms (BCC) an. Das Institutional Review Board hat die Erhöhung der Teilnehmerzahl von 60 auf 90 genehmigt. Die Studie, die derzeit an neun klinischen Standorten in den USA aktiv ist, wird auf weitere US-Standorte sowie zwei europäische Standorte ausgeweitet.
Die Studie hat bereits mehr als 45 Teilnehmer randomisiert, und eine Zwischenanalyse zeigt vielversprechende Ergebnisse: eine vollständige klinische Abheilungsrate von über 60 %. Untersucht werden zwei Dosierungsstufen von D-MNA (100μg und 200μg) im Vergleich zu Placebo, wobei beide Dosierungen eine gute Verträglichkeit ohne schwerwiegende Nebenwirkungen oder dosislimitierende Toxizitäten zeigen.
Das Unternehmen plant, vor Ende des zweiten Quartals 2025 eine Type-C-Meeting-Anfrage bei der FDA einzureichen. Zusätzlich strebt Medicus eine globale Validierung an, mit ausstehender Genehmigung in Abu Dhabi und potenzieller Zusammenarbeit in der Asien-Pazifik-Region.
- Interim analysis shows >60% complete clinical clearance rate
- Successfully enrolled 45+ patients with expansion to 90 approved
- Geographic expansion to Europe and pending UAE approval
- Both dose levels demonstrate good safety profile with no serious adverse events
- Phase 1 trial showed complete response in 6 participants
- Interim analysis results are preliminary and may not correlate with final findings
Insights
Medicus expands BCC trial with positive interim results showing >60% clearance rates and strong safety profile, advancing their non-invasive skin cancer treatment.
The expansion of Medicus Pharma's Phase 2 study for Nodular Basal Cell Carcinoma from 60 to 90 patients represents a significant development in their clinical program. BCC is the most common form of skin cancer globally, and the nodular subtype often requires surgical intervention. The IRB approval to increase patient enrollment and expand to European sites suggests the study is progressing well.
The interim analysis data shows encouraging signs with a complete clinical clearance rate exceeding 60% across the study arms. Importantly, the safety profile appears favorable with no dose-limiting toxicities or serious adverse events reported in either the 100μg or 200μg D-MNA dosage groups. This maintains consistency with their Phase 1 findings, where 6 participants with nodular BCC achieved complete responses.
The 1:1:1 randomization design comparing two active dose levels against placebo represents a robust approach to establishing dose-response relationship. The parallel regulatory strategy in the UAE, with planned sites at prestigious institutions like Cleveland Clinic Abu Dhabi, indicates a comprehensive global development approach.
However, as explicitly stated in the release, these interim findings are preliminary and may not correlate with the final study results. The planned FDA Type C meeting submission before the end of Q2 2025 will be an important milestone to watch for insights into the regulatory pathway.
Medicus's trial expansion demonstrates clinical progress, with positive interim efficacy, clean safety profile, and smart global regulatory strategy advancing their BCC treatment.
Medicus Pharma's strategic expansion of their SKNJCT-003 trial demonstrates meaningful progress in their clinical development program for D-MNA in basal cell carcinoma. With 45 participants already randomized, the company appears to be making steady enrollment progress toward the new 90-patient target. The geographic diversification into Europe and planned expansion to four UAE sites represents a sophisticated global development strategy.
The preliminary efficacy signal of >60% complete clinical clearance provides an encouraging indicator of potential therapeutic value. Equally important is the clean safety profile with no serious adverse events reported, consistent with their earlier Phase 1 results. For a small-cap pharmaceutical company (
The planned FDA Type C meeting submission in Q2 2025 will be a key regulatory interaction that could provide insights into the potential approval pathway. The multi-region approach with parallel submissions to health authorities in the UAE creates multiple opportunities for regulatory advancement.
This expansion comes with execution challenges, including maintaining consistency across international sites and managing increased operational complexity. However, the potential to develop a non-invasive treatment option for a common skin cancer represents a significant opportunity if the complete clinical study confirms these preliminary findings.
The Institutional Review Board Has Approved the Increase in Number of Patients from Sixty (60) to Ninety (90).
The Company to Expand the Study into Additional Trial Sites in Europe
Philadelphia, Pennsylvania--(Newsfile Corp. - April 21, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is pleased to announce that Institutional Review Board (IRB) has approved the increase in number of patients from sixty (60) to Ninety (90).
The phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States will expand into additional sites in United States, as well as two clinical trial sites in Europe.
The Company also announced that it has randomized more the forty-five (45) participants in the study and is on track to submit the package seeking a Type C meeting with the United States Food and Drug Administration (FDA) before the end of Q2 2025.
"Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very time appropriate," stated Dr. Raza Bokhari, Executive Chairman & CEO. "With our study design awaiting approval by the Department of Health in Abu Dhabi, and exploring collaboration in the Asia-pacific region, we are making promising progress in securing global validation of our novel, non-invasive treatment for BCC."
Earlier in March 2025, the Company's interim analysis showed that clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than
Clinical Trial Design
The clinical study is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 90 subjects presenting with BCC of the skin. The study evaluates 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, 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
Anna Baran-Djokovic, SVP Investor Relations
(305) 615-9162
adjokovic@medicuspharma.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). In July 2024, an updated package was submitted to the FDA. The study design is to evaluate the efficacy of two dose of two dose levels (100 and 200 ug) of D-MNA compared to placebo (P-MNA) in sixty (60) subjects with nodular BCC. Patient recruitment is currently underway in nine sites across the United States. In April 2025. Investigational review board increased the number of participants to Ninety (90) subjects. In March 2025 the company also announced a positively trending interim analysis for SKNJCT-003 demonstrating more the
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.
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FAQ
What are the interim results of Medicus Pharma's (MDCX) Phase 2 BCC trial?
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What is the geographic expansion plan for MDCX's SKNJCT-003 clinical trial?
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