On September 10, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, reported that an abridged Clinical Study Report (CSR) for SKNJCT-003 (NCT06608238) has been posted on ClinicalTrials.gov, providing transparent public access to the efficacy, safety, drug-delivery and clinical findings from the completed Phase 2 study.
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Publication of the abridged CSR represents an important scientific milestone for SkinJect and provides a transparent public record of the completed Phase 2 findings. The Company believes the dataset provides the clinical foundation for its focused development strategy, prioritizing the FDA-authorized SKNJCT-005 program in Gorlin syndrome patients with multiple basal cell carcinoma lesions, while pursuing strategic partnership opportunities to advance SkinJect in nodular basal cell carcinoma (BCC).
The randomized, double-blind, multicenter Phase 2 study enrolled 90 patients across ten U.S. investigative sites and evaluated two dose levels of SkinJect compared with a device-only microneedle comparator. All 90 enrolled patients completed the study without treatment discontinuations or study withdrawals, providing a complete clinical dataset for efficacy and safety evaluation.
The completed SKNJCT-003 CSR represents the definitive analysis of the Phase 2 program and incorporates the full clinical, pathological, and translational dataset generated during SKNJCT-003. Final efficacy analyses were conducted in the modified intent-to-treat population representing patients with centrally confirmed nodular basal cell carcinoma, providing what the Company believes to be the most clinically relevant assessment of SkinJect’s therapeutic performance in its intended target population.
Dr. Faisal Mehmud, Chief Medical Officer of Medicus, commented:
"Publication of the SKNJCT-003 abridged Clinical Study Report is an important milestone in the development of SkinJect. We believe that the completed Phase 2 study has provided the clinical information needed to define the next stage of development, including selection of the 200-mcg dose, continued improvement in clinical and histological clearance with longer follow-up, a favorable safety profile and important learnings around study design and assessment timing. These findings directly informed our FDA-authorized SKNJCT-005 program in Gorlin syndrome and provide a defined development package that we believe can support discussions with potential strategic partners interested in advancing SkinJect in nodular basal cell carcinoma."
Phase 2 Results Support a Focused, Capital-Efficient Development Strategy
Beyond reporting the efficacy and safety findings from SKNJCT-003, the completed Phase 2 program has defined key scientific elements relevant to future SkinJect development, including dose selection, efficacy endpoints, assessment timing, comparator selection and statistical design. Medicus is applying these learnings to its FDA-authorized new drug application (NDA)-enabling development program in Gorlin syndrome patients and believes the same body of evidence can support a potential strategic partner in advancing a registrational program in nodular basal cell carcinoma.
The scientific conclusions documented in the CSR include:
Selection of the 200 µg SkinJect patch as the proposed pivotal dose.
Adoption of a composite complete response endpoint incorporating both clinical and histological clearance.
Selection of a later primary efficacy assessment, reflecting continued improvement in treatment response observed with longer follow-up.
Replacement of the biologically active device-only comparator with a non-penetrating sham comparator designed to better isolate the pharmacologic contribution of SkinJect.
A randomized, double-blinded, sham-controlled registrational study intended to generate a robust, decision-grade clinical dataset.
A statistical design providing approximately 90% power to detect a clinically meaningful treatment difference while supporting discussions with FDA regarding a potential single pivotal study approach.
Collectively, these findings provide a scientific bridge from the completed SKNJCT-003 study to the Company’s current SkinJect strategy, where the Company believes the platform has the potential for greater clinical differentiation, a more focused regulatory pathway and attractive rare-disease commercial economics in treating Gorlin syndrome patients with multiple BCC lesions, while preserving the broader opportunity in nodular BCC through potential strategic partnering.
Medicus intends to continue clinical development through SKNJCT-005, in Gorlin syndrome, a rare autosomal dominant disease in which patients can develop numerous BCC lesions throughout their lifetime, frequently requiring repeated surgical or other lesion directed procedures. Approximately 11,000 patients with Gorlin syndrome in the United States are estimated to have active BCC, representing approximately 50,000 Gorlin-associated BCC procedures annually. The U.S. Food and Drug Administration has issued a "Study May Proceed" letter authorizing initiation of the Company’s NDA-enabling registrational Phase 2b clinical study, SKNJCT-005, evaluating SkinJect 200 µg skin patch in patients with Gorlin syndrome presenting with multiple BCCs. The study is designed to enroll up to approximately 50 patients.
The Company believes concentrating SkinJect development on Gorlin syndrome could provide several potential strategic advantages beyond the more broadly competitive sporadic BCC market. Medicus has submitted applications to the FDA for Orphan Drug Designation ("ODD") and Rare Pediatric Disease ("RPD") designation. If granted and applicable statutory requirements are ultimately satisfied, these designations could provide important regulatory and economic benefits, including potential orphan-drug incentives and potential eligibility for a Rare Pediatric Disease Priority Review Voucher ("RPD PRV").
The Gorlin-focused strategy may also potentially support a differentiated reimbursement profile. A Company-commissioned 2026 independent commercial assessment incorporating interviews with physicians and payers modeled rare-disease-anchored net pricing of approximately $25,800 per treatment, an implied U.S. total addressable market of approximately $1.1 billion, and potential peak U.S. revenue of approximately $383 million. These estimates are non-risk-adjusted and dependent upon successful clinical development, regulatory approval, reimbursement and commercial adoption.
Scientific Dissemination
Publication of the abridged Clinical Study Report and public availability of the SKNJCT-003 results represent the first step in the Company’s broader scientific dissemination strategy. Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming major international scientific congress and for publication in a leading peer-reviewed medical journal, further supporting independent review of the study findings and continued engagement with the global dermatology and oncology communities; however, there is no guarantee that such dataset will be accepted for presentation or for publication.
(Press release, Medicus Pharma, SEP 10, 2026, View Source [SID1234670722])