Medicus Pharma (NASDAQ:MDCX) said Monday it has received positive feedback from U.S. regulators that clears a path for the company to continue developing its experimental skin patch treatment for basal cell carcinoma, the most common form of skin cancer.
The Philadelphia-based biotech said the Food and Drug Administration agreed it can pursue approval of its Skinject patch under what is known as the 505(b)(2) regulatory pathway.
This route allows companies to rely in part on existing data from already-approved drugs, potentially saving both time and money compared with starting entirely from scratch.
Skinject uses a dissolvable microneedle array, essentially a patch lined with microscopic needles, that delivers doxorubicin, a widely used chemotherapy drug, directly into skin tumours.
By doing so, Medicus aims to offer a non-invasive alternative to surgery, which is currently the standard treatment for basal cell carcinoma. The company estimates the potential market for this therapy could reach about $2 billion.
The FDA’s guidance followed what is known as a Type C meeting, a formal consultation in which the agency provides advice on trial design and regulatory requirements.
According to Medicus, regulators endorsed its plan to run randomized, placebo-controlled studies and gave input on details such as tumour size limits, patient eligibility and safety monitoring.
The FDA also recommended improvements to the patch itself, including the addition of an adhesive layer and a device to ensure consistent application.
Raza Bokhari, Medicus’s executive chairman and chief executive, called the decision “a game changer,” noting that the 505(b)(2) pathway allows the company to leverage existing doxorubicin safety data.
“We will not only realize substantial drug development cost savings but also time savings compared to a traditional full development program,” he said.
Medicus is currently running a mid-stage clinical trial, known as SKNJCT-003, across nine sites in the United States.
The company said it expects to finish enrolling patients by the end of 2025 and to meet with the FDA early the following year to discuss the next steps toward late-stage testing.
An interim analysis earlier this year showed more than 60% of patients experienced tumour clearance, though those findings remain preliminary until the full trial is complete.
In parallel, Medicus is expanding testing to Europe and the Middle East, with a study underway in the United Arab Emirates involving six hospitals, including Cleveland Clinic Abu Dhabi.