Medicus Pharma Ltd. announced the receipt of comments from the U.S Food and Drug Administration (FDA). The clinical non-hold comments from the FDA consider the results of the study exploratory and request the Company to provide data from clinical studies (SKNJCT-001) to support the dose of 100ug and 200ug of micro-array needles containing doxorubicin (D-MNA). FDA has also requested the Company to provide an updated investigator brochure that include information from the clinical studies SKNJCT-001 and SKNJCT-002; specifically, include data regarding any adverse events/dose limiting toxicities at each dose level.

Earlier this year, the Company had submitted to the FDA for comments a Phase 2 Investigational New Drug (IND) clinical protocol (SKNJCT-003) to non-invasively treat basal cell Carcinoma (BCC) of the skin using micro-array needles containing do xorubicin (D -MNA). The clinical study, SKNJCT-003, is designed to be a randomized, double-blinded, placebo-controlled (P-MNA), multi-center study enrolling up to 60 subjects presenting with nodular type BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to placebo in patients with nodular BCC.

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 100ug of D-MNA, and a high-dose group receiving 200ug of D-MNA. The high-dose, 200ug D-MNA, proposed in the study is the maximum dose that was used in Skinject's Phase 1 safety and tolerability study (SKNJCT-001") completed in March 2021. 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 adverse events (AE). 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 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 intends to make a full submission to the FDA in second quarter 2024 and shall provide the information requested by the FDA as well as include CMC (Chemistry, manufacturing, and Controls) stability data.