Medicus Pharma Ltd. announced that it has published the abbreviated clinical study report (CSR) from the SKNJCT-001 Phase 1 safety and tolerability study. SKNJCT-001 is an open-label, dose-escalation, placebo-controlled trial to evaluate dose limiting toxicity (DLT), maximum tolerated dose (MTD), safety and tolerability of dissolvable microneedle arrays loaded with the chemotherapeutic agent doxorubicin (D-MNA) in participants with basal cell carcinoma (BCC). The study enrolled 13 subjects across five dose levels (25 ug, 50 ug, 100 ug, 200 ug, and placebo).

The associated NCT number for the SKNJCT-001 trial is NCT03646188. Phase 1 study, SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was found to be safe and well-tolerated across all dose levels in all thirteen (13) participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAE), or study discontinuations.

Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The maximum tolerated dose was established at 200 ug. The CSR also describes the efficacy of the investigational product, D- MNA, with 6 subjects experiencing complete responses.

The Complete response is defined as the disappear 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. The Company, earlier this year, has submitted to the United States Food and Drug Administration (FDA) a Phase 2 Investigational New Drug (IND) clinical protocol (SKINJCT-003) to non-invasively treat BCC using micro-array needles containing doxorubicin.

The Company is seeking comments from the FDA to revise and amend the IND and finalize the protocol.