Medicus Pharma Ltd. Expands Clinical Study in Asia Pacific
Medicus Pharma Ltd. (NASDAQ: MDCX) has exciting news to share regarding its collaboration with Swanielle Inc. This partnership aims to explore the expansion of the ongoing Phase 2 clinical study for the innovative treatment of Basal Cell Carcinoma (BCC) within the Asia-Pacific region.
Collaboration with Swanielle Inc.
The collaboration agreement allows Swanielle, a specialized healthcare consulting firm, to facilitate connections with pharmaceutical or biotech companies in Southeast Asia. This initiative will support Medicus in its ambition to broaden the Phase 2 clinical study, which is vital for gathering more comprehensive data on the treatment's safety and efficacy.
Current Phase 2 Clinical Study Progress
The Phase 2 clinical study, designated SKNJCT-003, is currently active across nine clinical sites in the United States. So far, the study has successfully randomized over 25% of the expected 60 participants. Looking ahead, Medicus plans to conduct an interim data analysis in the early months of 2025, followed by submitting findings to the FDA as part of preparations for a Type C meeting. This meeting aims to establish a clear path for the clinical development program, with the goal of transitioning from an exploratory trial to a pivotal trial.
Design and Objectives of the Clinical Trial
The SKNJCT-003 study is crafted as a randomized, double-blind, placebo-controlled trial intended to enroll up to 60 participants diagnosed with BCC of the skin. This clinical trial seeks to evaluate the treatment efficacy of two dose levels of D-MNA juxtaposed against a placebo control. Randomization will place subjects into one of three groups: a control group receiving a placebo, a low-dose group administering 100?g of D-MNA, and a high-dose group utilizing 200?g of D-MNA.
Safety and Tolerability Findings
Significantly, the 200?g dose of D-MNA was identified as the maximum dose employed in the previous Phase 1 safety and tolerability study (SKNJCT-001) concluded successfully in early 2021. The earlier trial met its key objective, demonstrating that D-MNA was well-tolerated by all participants without any dose-limiting toxicities or severe adverse events. Furthermore, assessments revealed no concerning systemic effects or significant abnormal laboratory findings.
Looking Forward
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, expressed enthusiasm about the advancements in their clinical development program. He emphasized the importance of collaborating with Swanielle to gather crucial data on the treatment's efficacy and safety. This partnership aims to enhance the evaluation of the pivotal trial that Medicus plans to embark upon shortly.
The agreement with Swanielle spans an initial duration of one year, starting from the beginning of December. Under this agreement, Swanielle will receive a retainer fee of $22,500, coupled with a variable success fee of 1% to 5%, contingent upon securing a definitive agreement with a reputable partner.
Contact Information
For inquiries regarding this partnership and ongoing trials, individuals can reach out to:
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. is a dedicated biotech and life sciences company focused on introducing innovative and transformative therapeutic assets to the market. Through its wholly-owned subsidiary, SkinJect Inc., Medicus works on commercializing a groundbreaking non-invasive treatment for basal cell skin cancer. Utilizing a patented dissolvable microneedle patch allows for the targeted delivery of the chemotherapeutic agent designed to eradicate tumor cells effectively. The Phase 1 study conducted previously has encouraged the company to move forward with the IND clinical protocol for Phase 2 trials, continuing to uphold a commitment to advancing treatment methodologies in oncology.
Frequently Asked Questions
What is the goal of the collaboration between Medicus Pharma and Swanielle?
The collaboration aims to explore the expansion of the Phase 2 clinical study for Basal Cell Carcinoma treatment in the Asia-Pacific region.
What are the main findings from the Phase 1 study of D-MNA?
The Phase 1 study showed D-MNA was well-tolerated, with no severe adverse events or dose-limiting toxicities among participants.
What is the design of the SKNJCT-003 clinical trial?
The trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy of two dosing levels of D-MNA compared to a placebo.
When can we expect updates on the interim data analysis?
An interim data analysis is scheduled for early 2025, with findings to be submitted to the FDA thereafter.
How can I contact Medicus Pharma for more information?
Interested parties can contact Carolyn Bonner at (610) 636-0184 or via email at cbonner@medicuspharma.com.
