Technological development of pharmaceutical compositions for sub-retinal fibrosis in preclinical models. Implications in the consolidation of a company focused on research and innovative therapies for posterior segment eye diseases

Abstract

The focus of Startup R&R NOVABIO OCULAR is the research and development of therapeutic and diagnostic innovations (hard science) for posterior segment eye diseases. In Brazil, few pharmaceutical industries operate in this field. Our initial mission is age-related macular degeneration (AMD). AMD is the leading cause of blindness in individuals over 55 years of age, characterized by progressive loss of central retinal vision, associated with risk factors such as aging, heredity, smoking, among others. It is a public health challenge as the population aging in Brazil and worldwide. There are currently no approved treatments for dry AMD. Despite the great advances with intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) for wet AMD (the most severe type), the treatment is 40% effective and there is a high chance of recurrence. The low efficacy can be attributed to anti-VEGF therapy not slowing the progression of fibrosis associated with vision loss. Therefore, there are still space to be explored in this area. In this scenario, scientists have identified opportunities based on their skills, knowledge and discoveries. In PIPE Phase 1 of this project, prototypes of unexplored therapeutic agents capable of intervening in the process of cell degeneration and fibrosis in preclinical models that mimic both forms of AMD were identified. In concomitance, a nanoformulation was also developed to deliver the compounds topically or extend the availability of intraocular injections. The Phase 1 proof-of-concept results were promising and have competitive potential. The PIPE Phase 2 step will be crucial for improving the design of this technologies, filing for a patent, carrying out robust pre-clinical studies for the conclusion of the minimum viable product (MVP) and business negotiation for the co-development and future Phase 1 clinical trials. (AU)