Mimetica’s lead drug, MTC896, is a novel small molecule that is designed to reduce sebum in a different manner to isotretinoin. MTC896 works by blocking the Melanocortin-5 receptor (MC5R) a novel target for the treatment of acne. MC5R is located on the surface of sebocytes, the cells that make sebum. It is proposed that in binding to MC5R, MTC896 prevents the receptor from signaling, thereby causing a reduction in the production of sebum.
Initial human clinical trials with a topical formulation of Mimetica's MTC896 have shown the drug displays a favourable safety profile and has shown positive indications that it could significantly enhance the treatment options for acne.
The MTC896 clinical program has been conducted in the US in accordance with ICH requirements, GCP and the FDA regulations and guidelines for the conduct of clinical trials. MTC896 has been tested in an extensive safety program consisting of three Phase 1 clinical trials and a pilot Phase 2 study. The Phase 1 clinical trials assessed the safety and tolerability of the MTC896 Gel, specifically the potential for MTC896 Gel to cause skin irritation, phototoxicity or skin sensitisation in normal, healthy subjects. The MTC896 Gel was well tolerated by the skin, did not photosensitise the skin to UV radiation and no allergic contact sensitisation was observed following the Repeat Insult Patch Test.
A pilot phase 2 study investigated the potential of MTC896 Gel to reduce sebum production on the forehead of otherwise normal healthy individuals with oily skin (non-acne population) following daily applications for four weeks. The MTC896 Gel was well tolerated with no significant skin irritation or safety concerns recorded at any point during the study. Despite a relatively short treatment period, efficacy signals were obtained in individuals receiving the MTC896 Gel compared to a Vehicle Control Gel. a downward trend in sebum and squalene secretion levels was observed, particularly in individuals with higher baseline levels of oil production, justifying further clinical development
Mimetica is now preparing to more fully assess the effects of MTC896 Gel in acne patients.