Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX), a biotechnology company specializing in non-invasive dermatological treatments, is gearing up for a pivotal year in 2025.
The company is advancing SkinJect, its flagship asset for basal cell carcinoma, while planning significant expansions to its drug pipeline.
SkinJect, a non-invasive treatment utilizing patented micro-needle array technology, targets the more than 5 million new cases of basal cell carcinoma diagnosed annually in the US.
Following promising Phase 1 trial results—where six out of 13 patients achieved complete clinical responses—the company is conducting a Phase 2 trial involving 60 patients at nine US sites.
CEO Raza Bokhari outlined the company’s plans for the coming year at a recent investor road show in New York.
Medicus plans to hold a Type C meeting with the FDA in the second quarter of 2025, aiming to secure fast-track designation for SkinJect, a key step toward transitioning the trial into a pivotal study.
Expanding patient recruitment globally, including in Asia-Pacific and the Middle East, is also on the horizon to support the program's progression.
In addition to its work on basal cell carcinoma, Medicus is leveraging its expertise to address other significant conditions. Plans are underway to initiate studies for non-melanoma skin diseases, including actinic keratosis and squamous cell carcinoma in situ.
The company also seeks to extend its technology to veterinary applications, with a focus on squamous cell carcinoma in horses. By leveraging an orphan drug designation, Medicus aims to capitalize on this niche market while demonstrating the versatility of its platform.
Since its public debut in 2023, Medicus Pharma (NASDAQ:MDCX, TSX-V:MDCX) has raised $21.1 million, which has fueled its ongoing clinical trials and pipeline expansion. As part of its growth strategy, the company is actively exploring potential partnerships with big pharmaceutical companies.
“Our goal is to advance SkinJect through proof of concept and position it for collaboration or acquisition by a larger partner that excels in commercialization,” Bokhari explained.
With ambitious clinical and regulatory milestones on the agenda, the company is poised to advance SkinJect while building a broader portfolio of dermatological treatments.
“With such a full plate, we continue to actively seek a collaborative partner to transition the program while also exploring opportunities to acquire novel assets,” Bokhari said.
“We are excited about achieving these milestones and advancing toward our goals.”