New strategies for onychomycosis treatment: development of a curcumin photosensitizer based formulation and an irradiation system for the treatment of onychomycosis

• Grant number: 17/09238-0
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Start date: May 01, 2018
• End date: April 30, 2021
• Field of knowledge: Biological Sciences - Microbiology
• Principal Investigator: Sergio Perussi Filho
• Grantee: Sergio Perussi Filho
• Company: PDT Pharma Indústria e Comércio de Produtos Farmacêuticos Ltda. - EPP
• CNAE: Fabricação de medicamentos para uso humano ; Fabricação de preparações farmacêuticas
• City: Cravinhos
• Pesquisadores principais: Ana Paula da Silva
• Associated researchers: Anderson Orzari Ribeiro ; Inara Amoroso da Silva Luccas ; Marcelo de Carvalho ; Natalia Mayumi Inada
• Associated research grant: 15/18615-7 - New strategies to treat onychomycosis: development of curcumin photosensitizing formulations, AP.PIPE
• Associated scholarship(s): 18/19291-9 - New strategy for the treatment of onychomycosis: development of a formulation consisting of technology curcumin-based photosensitizer and irradiation system for treatment of onychomycosis, BP.TT; 18/13988-8 - New strategy for the treatment of onychomycosis: development of a formulation consisting of technology curcumin-based photosensitizer and irradiation system for treatment of onychomycosis, BP.TT

Abstract

After satisfactory conclusion of PIPE 1 project, we present here the proposal to advance in the necessary research to develop a KIT (photosensitizing formulation + irradiation system) to be commercialized for the treatment of onychomycosis by photodynamic therapy. During the Phase 1 of the project, we developed a photosensitizing formulation based on curcumin that proved to be very effective (in vitro) against onychomycosis fungi under irradiation of blue LED light. At the end of the study, a patient, under initial test conditions, underwent three sessions of onychomycosis treatment with the developed formulation and the LED prototype. The excellent results obtained for the patient indicated the possibility of elaborating a commercial treatment, composed of a KIT containing a photosensitizing formulation and a portable LED system, that could be used for the treatment of onychomycosis both by a professional (dermatologist) and by the patient. It is expected that this technology will become a radical innovation in the national market, changing the paradigm of treatment of this disease that affects between 20 and 30 million people in Brazil. Conventional treatments, via systemic and topical drugs, have low total cure rates and high patient costs. In this context, a new form of treatment can change the way to treat this disease and increase the rates of total cure at compatible costs. To move forward with this development, PDT Pharma needs to overcome a number of scientific and technological challenges. First, we need to perform the necessary research to define the parameters of formulation stability and its production. In addition, we need to investigate the parameters for the portable LED and the best protocol for the treatment of patients (application of medication, time of exposure to LED, average number of sessions required). To complete these studies and to prepare for the commercialization, it will be necessary to carry out the treatment of approximately 200 patients in a clinical trial. This scientific and technological research, with concrete perspectives of innovation and development of a new technology for the treatment of onychomycosis is submitted here for PIPE Phase 2. We understand that this technology will bring important economic and social impacts for the company and for Brazilian public health. For the company, the possibility to explore a market with great economic dimension. For the country, by making available a 100% treatment developed in the country, with a chemical that is used as cheap raw material. (AU)