Medicus Pharma reports over 50% patient enrollment in Phase 2 study for basal cell carcinoma treatment, aiming for FDA fast-track approval.
Quiver AI Summary
Medicus Pharma Ltd. announced that over 50% of the 60 patients are now enrolled in its phase 2 clinical study (SKNJCT-003) across nine U.S. sites, which aims to evaluate the efficacy of D-MNA for treating basal cell carcinoma (BCC) of the skin. The company plans to conduct an interim data analysis by the end of Q1 2025 and will submit its findings to the FDA for a Type C meeting in Q2 2025 to discuss the clinical pathway and potential fast-tracking of the development program. The study is randomized, double-blind, and placebo-controlled, comparing two doses of D-MNA to a placebo. Previous Phase 1 results indicated D-MNA was well-tolerated, with participants showing promising responses. Medicus Pharma is focused on innovative therapeutics, with SkinJect Inc. as its subsidiary targeting non-invasive BCC treatments via a microneedle patch.
Potential Positives
- Medicus Pharma has successfully randomized over 50% of the patients required for its phase 2 clinical study, demonstrating effective progress in clinical trials.
- The company is on track to complete an interim data analysis by the end of Q1 2025, which could provide crucial insights into the study’s outcomes.
- The planned Type C meeting with the FDA in Q2 2025 aims to gain alignment on the product development path, potentially facilitating faster approval processes.
- The investigational product D-MNA has shown promising efficacy, with six participants achieving complete response in the study, indicating positive treatment effects.
Potential Negatives
- The press release includes extensive cautionary language regarding forward-looking statements, indicating potential risks and uncertainties that may affect the company's plans and future performance.
- Despite completion of Phase 1 studies, the company is still in the process of patient recruitment for the Phase 2 study, which may reflect delays or challenges in clinical development.
- The company's future success heavily relies on FDA approval, which is inherently uncertain and could significantly impact its clinical development plans and market confidence.
FAQ
What is the purpose of the phase 2 clinical study SKNJCT-003?
The study aims to evaluate the efficacy of D-MNA for treating basal cell carcinoma (BCC) of the skin.
How many patients are enrolled in the clinical trial?
More than 50% of the 60 patients expected to be enrolled have been randomized in the study.
When will the interim data analysis be completed?
The interim data analysis is on track to be completed before the end of Q1 2025.
What type of meeting will Medicus Pharma request with the FDA?
Medicus Pharma plans to request a Type C meeting to discuss the product development and clinical pathway.
What were the results of the Phase 1 safety study SKNJCT-001?
SKNJCT-001 met its primary objective, showing safety and tolerability with no serious adverse events among participants.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
PHILADELPHIA, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is also pleased to announce that its phase 2 clinical study (SKNJCT-003) which is currently underway in nine (9) clinical sites in United States, has now randomized more than 50% of the 60 patients expected to be enrolled in the study.
The Company also announced that it is on track to complete an interim data analysis before the end of Q1 2025 and to submit its findings to the United States Food and Drug Administration (FDA) as part of a package seeking a Type C meeting with the FDA in Q2 2025.
The purpose of the Type C meeting is to formally discuss the product development and gain further alignment on the clinical pathway. The Company’s aim is to gain FDA’s consent to fast-track the clinical development program.
Clinical Trial Design
The clinical study, SKNJCT-003, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multi-center study enrolling up to 60 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 thirteen (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.
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 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-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.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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