Medicus Pharma enters collaboration agreement with Swanielle

Medicus Pharma (MDCX) announced an agreement with Swanielle to explore expansion of Phase 2 clinical study for treatment of Basal Cell Carcinoma in the Asia-pacific region. Under the agreement, Swanielle will help identify a pharmaceutical/biotech company or companies in Southeast Asia to partner with Medicus to expand the Phase 2 clinical study in the Asia Pacific region. The company is also pleased to announce that the phase 2 clinical study is currently underway in nine clinical sites in United States and has already randomized more than 25% of the 60 patients expected to be enrolled in the study. Medicus is planning to initiate an interim data analysis in Q1 2025 and submit its findings to the United States Food and Drug Administration as a part of a package seeking a Type C meeting with the FDA in Q2 2025. The purpose of the Type C meeting is to formally discuss the product development and gain further alignment on the clinical pathway. The Company’s aim is to fast track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial. The clinical study, SKNJCT-003, is designed to be a randomized, double-blind, placebo-controlled, multi-center study enrolling up to 60 subjects presenting with BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100undefined of D-MNA, and a high-dose group receiving 200undefined of D-MNA. The high-dose, 200undefined D-MNA, proposed in the study is the maximum dose that was used in the Company’s Phase 1 safety and tolerability study completed in March 2021. SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA was well-tolerated across all dose levels in all thirteen participants enrolled in the study, with no dose-limiting toxicities, or serious adverse events. Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with 6 participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end of study visit. The participants profile demonstrating complete responses was diverse, and all participants had nodular subtype of BCC. The agreement with Swanielle has an initial term of one year, commencing on December 1st, 2024. Under the agreement, Swanielle will receive a retainer fee of $22,500. In addition to the retainer, there is a variable rate success fee of 1%-5% dependent on the execution of a definitive agreement between company and a qualifying partner.