NAC-GED-0507 Project Development Status
Phase 1 and Phase 2 CTs with NAC-GED-0507 Gel performed in subjects affected by facial acne.arge Phase 2b clinical trial completed, topline results available.
IND # 143424 active.
Phase 1, double-blind, placebo controlled CT with NAC-GED-0507 Cream performed in mild to moderate psoriasis.
Foam formulation under development for large clinical trials.
IND # 134470 active.
Nonclinical pharmacology studies ongoing for target validation and possible use in the rare diseases Lichen Planopilaris and Localized Scleroderma.
Nonclinical Pharmacology Overview
Acne and Psoriasis
The main nonclinical pharmacology studies that supported the clinical development of NAC-GED-0507 for the treatment of psoriasis and acne, were performed in vitro, ex vivo and in vivo. The studies were performed with NAC-GED-0507 and/or its metabolic precursor GED-0507.The data indicate that NAC-GED-0507 acts on the main pathogenetic aspects of psoriasis and acne:
Acne vulgaris (Mastrofrancesco et al, 2017):
- Keratinocytes and sebocytes inflammatory response and pro-inflammatory cytokines secretion
- Changes in the secretion rates and composition of sebum in sebocytes
Psoriasis (Mastrofrancesco et al, 2014):
- Inflammatory response and secretion of pro-inflammatory cytokines of keratinocytes
- Aberrant terminal differentiation and hyperproliferation of epidermal keratinocytes