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)
Rhea-AI Summary
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.
Positive
- 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
Negative
- Small patient sample size (36) in UAE Phase 2 trial
- Still in early clinical development phase
- Multiple competing trials may extend development timeline
News Market Reaction
On the day this news was published, MDCX gained 12.16%, reflecting a significant positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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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