Phase 2 SkinJect Data Support 200-µg Dose for BCC Development

Medicus Pharma Ltd. (NASDAQ: MDCX) has published an abridged Clinical Study Report (CSR) for its Phase 2 SKNJCT-003 trial (NCT06608238) of SkinJect®, (NCT06608238) an investigational dissolvable microneedle array (D-MNA) patch, on ClinicalTrials.gov. The completed analysis supports the 200-µg SkinJect patch as the company’s proposed pivotal dose for future development.¹

Medicus is using the dataset to support its FDA-authorized registrational program in patients with Gorlin syndrome and multiple basal cell carcinoma (BCC) lesions, while pursuing a strategic partner to advance the therapy in nodular BCC.¹

The CSR represents the definitive Phase 2 analysis of SKNJCT-003 and incorporates the full clinical, pathologic, and translational dataset generated during the study. Final efficacy analyses were conducted in the modified intent-to-treat population, representing patients with centrally confirmed nodular BCC.¹

SKNJCT-003 was a randomized, double-blind, multicenter Phase 2 study conducted at 10 US investigative sites. The trial enrolled 90 patients and evaluated 2 dose levels of SkinJect against a device-only microneedle comparator. All 90 enrolled patients completed the study without treatment discontinuations or withdrawals, according to Medicus.¹

200-µg Dose Selected for Future Development

Based on the completed dataset, Medicus selected the 200-µg SkinJect patch as its proposed pivotal dose. The company also reported continued improvement in clinical and histological clearance with longer follow-up, supporting the selection of a later primary efficacy assessment for future studies.¹

The Phase 2 findings also informed several other elements of SkinJect’s future clinical development. Medicus adopted a composite complete response endpoint incorporating both clinical and histological clearance rather than relying on either measure alone.¹

The company also plans to replace the device-only microneedle comparator used in SKNJCT-003 with a nonpenetrating sham comparator designed to better isolate the pharmacologic contribution of SkinJect. The planned registrational design is randomized, double-blind, and sham-controlled.¹

Safety and Statistical Design

According to Medicus, SkinJect demonstrated a favorable safety profile across both dose levels in SKNJCT-003, with no new safety signals reported. All 90 patients completed the study without treatment discontinuations or study withdrawals.¹

The completed Phase 2 dataset also informed a statistical design providing approximately 90% power to detect a clinically meaningful treatment difference. Medicus said the design is intended to support discussions with the FDA regarding a potential single pivotal study approach.¹

Faisal Mehmud, MD, chief medical officer of Medicus Pharma, said:

“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.”

We believe that the completed Phase 2 study has provided the clinical information needed to define the next stage of development - Faisal Mehmud, MD, chief medical officer of Medicus Pharma

SKNJCT-005 Moves Into Gorlin Syndrome

Medicus is now prioritizing SKNJCT-005, its FDA-authorized NDA-enabling registrational Phase 2b study evaluating the 200-µg SkinJect patch in patients with Gorlin syndrome who present with multiple BCCs. The study is designed to enroll up to approximately 50 patients.¹

Gorlin syndrome is a rare autosomal dominant disorder in which patients can develop numerous BCC lesions throughout their lifetime, often requiring repeated surgical or other lesion-directed procedures. Medicus estimates that approximately 11,000 patients with Gorlin syndrome in the US have active BCC, accounting for approximately 50,000 Gorlin-associated BCC procedures annually.¹

The FDA has issued a “Study May Proceed” letter authorizing initiation of SKNJCT-005. Medicus said the dose, efficacy endpoint, assessment timing, comparator, and statistical design selected from SKNJCT-003 are informing the Gorlin syndrome program.¹

Regulatory and Commercial Strategy

Medicus has submitted applications to the FDA for orphan drug designation and rare pediatric disease (RPD) designation for SkinJect in Gorlin syndrome. If granted and applicable statutory requirements are ultimately satisfied, the designations could provide regulatory and economic benefits, including potential eligibility for a Rare Pediatric Disease Priority Review Voucher.¹

A company-commissioned 2026 independent commercial assessment incorporating interviews with physicians and payers modeled net pricing of approximately $25,800 per treatment, an implied US total addressable market of approximately $1.1 billion, and potential peak US revenue of approximately $383 million. Medicus noted that the estimates are non-risk-adjusted and depend on successful clinical development, regulatory approval, reimbursement, and commercial adoption.¹

While prioritizing Gorlin syndrome, Medicus continues to seek a strategic partner to potentially advance SkinJect into a registrational program for nodular BCC.¹

Next Steps for SkinJect

Publication of the abridged CSR is also the first step in a broader scientific dissemination strategy for the SKNJCT-003 findings. Medicus has submitted the complete Phase 2 dataset for presentation at a forthcoming major international scientific congress and for publication in a peer-reviewed medical journal, although acceptance for either has not been guaranteed.¹

The company plans to continue clinical development through SKNJCT-005 while using the completed Phase 2 dataset to support potential partnership discussions for further development of SkinJect in nodular BCC.¹

References

1. Medicus Pharma publishes abridged final Phase 2 SkinJect® Clinical Study Report (CSR) results identifying 200 µg D-MNA patch as the lead development dose. Medicus Pharma Ltd. News release. September 10, 2026. Accessed September 10, 2026. https://www.biospace.com/press-releases/medicus-pharma-publishes-abridged-final-phase-2-skinject-clinical-study-report-csr-results-identifying-200-%C2%B5g-d-mna-patch-as-the-lead-development-dose
2. Study of SkinJect in subjects with nodular basal cell carcinoma (SKNJCT-003). ClinicalTrials.gov identifier: NCT06608238. Updated 2026. Accessed September 10, 2026. https://clinicaltrials.gov/study/NCT06608238