Medicus Pharma (NASDAQ:MDCX) said on Thursday that its experimental microneedle-based therapy showed encouraging efficacy in a mid-stage clinical trial for treating Basal Cell Carcinoma, with the highest-dose group achieving 73% clinical clearance of lesions.
The Phase 2 randomized, double-blind, placebo-controlled study enrolled 90 patients with nodular basal cell carcinoma and evaluated two doses of the company’s doxorubicin microneedle array (D-MNA), a non-invasive treatment designed to deliver chemotherapy through the skin.
At 57 days after treatment, the 200-microgram dose group achieved 73% clinical clearance and 40% histological clearance confirmed by biopsy, according to a statement from Medicus.
In comparison, the placebo group recorded clinical clearance of 38% and histological clearance of 38% at the same timepoint.
The trial also included a 100-microgram dose group, which achieved clinical clearance of 42% and histological clearance of 33% at Day 57.
The company said clearance rates increased between the first evaluation at Day 29 and the later assessment at Day 57, suggesting continued biological activity of the therapy over time.
“We are extremely encouraged by these topline results, which not only validate management’s scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity, particularly at the 200-microgram dose level,” said CEO Dr Raza Bokhari.
“The observed increase in clearance rates at Day 57 in the higher-dose cohort reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development. Importantly, we believe this dataset strengthens our position in ongoing and prospective partnering discussions and may accelerate strategic engagement as we evaluate optimal pathways for value creation.”
The company said the results could support an end-of-Phase-2 meeting with the U.S. Food and Drug Administration in the first half of 2026.
Medicus added that the full clinical study report, including safety analyses and additional procedural observations, is expected to be completed in the second quarter of 2026, and the company does not anticipate material changes to the reported efficacy findings.
The trial was not designed as a registrational study, and the company cautioned that the results do not guarantee regulatory approval.
Medicus said its development strategy is to advance select programs through Phase 2 proof-of-concept trials and then seek licensing or strategic partnerships with established pharmaceutical companies for late-stage development and commercialization.