Medicus Pharma to Use 200 µg SkinJect Dose for Registrational Study After Positive Phase 2
Medicus Pharma’s Phase 2 trial of SkinJect showed the 200 µg cohort achieved the highest clinical clearance by Day 57, surpassing the 100 µg arm’s 50% clearance by Day 29. The company will advance the 200 µg dose in its registrational study plan, seeking FDA EOP2 feedback and strategic partners.
1. Phase 2 Trial Results
Medicus Pharma’s Phase 2 SkinJect study enrolled 100 µg and 200 µg cohorts plus a device-only arm. The 100 µg group achieved 50% clinical clearance by Day 29 with further improvement by Day 57, while the 200 µg cohort showed the highest activity across efficacy endpoints through Day 57.
2. Registrational Strategy
Based on topline data, the company will advance the 200 µg dose in its registrational study plan via the 505(b)(2) pathway. The strategy includes refined endpoints, updated biopsy timing, treatment schedules and preparing for an End-of-Phase 2 meeting with the FDA.
3. Device-Only Arm Findings
The device-only arm provided mechanistic insights into the microneedle array’s effects but its therapeutic impact is not central to regulatory submissions. The focus remains on doxorubicin-containing microneedle arrays for nodular basal cell carcinoma.
4. Next Steps and Partnerships
Medicus Pharma will finalize its Clinical Study Report concentrating on active cohorts and dose-response data. The dataset aims to support regulatory engagement, drive strategic partnerships and advance SkinJect as a non-surgical treatment option for nodular BCC.