Why do few drug delivery systems to combat neglected tropical diseases reach the market? An analysis from the technology’s stages

Many drugs used to combat schistosomiasis, Chagas disease, and leishmaniasis (SCL) have clinical limitations such as: high toxicity to the liver, kidneys and spleen; reproductive, gastrointestinal, and heart disorders; teratogenicity. In this sense, drug delivery systems (DDSs) have been described in the literature as a viable option for overcoming the limitations of these drugs. An analysis of the level of development (TRL) of patents can help in determine the steps that must be taken for promising technologies to reach the market. This study aimed to analyze the stage of development of DDSs for the treatment of SCL described in patents. In addition, we try to understand the main reasons why many DDSs do not reach the market. In this study, we examined DDSs for drugs indicated by WHO and treatment of SCL, by performing a search for patents. In this present work we provide arguments that support the hypothesis that there is a lack of integration between academia and industry to finance and continue research, especially the development of clinical studies. We cite the translational research consortia as the potential alternative for developing DDSs to combat NTDs.

用于对抗血吸虫病（schistosomiasis）、恰加斯病（Chagas disease）与利什曼病（leishmaniasis，以下简称SCL）的多数药物均存在临床局限性，包括：对肝、肾、脾脏具有高毒性；引发生殖系统、胃肠道及心脏功能紊乱；以及致畸性。在此背景下，药物递送系统（drug delivery systems, DDSs）被现有文献证实为克服上述药物局限性的可行方案。对专利的技术就绪水平（technology readiness level, TRL）进行分析，有助于明确具备应用前景的技术从研发走向市场化所需的具体步骤。本研究旨在分析专利文献中记载的用于治疗SCL的药物递送系统的研发阶段。此外，本研究尝试阐明多数药物递送系统未能实现市场化的核心原因。本研究通过专利检索，针对世界卫生组织（World Health Organization, WHO）推荐的用于治疗SCL的药物对应的药物递送系统展开了调研。本研究提出论据，支持“学界与业界缺乏协同以提供研发资金并推进后续研究，尤其是临床研究开发”这一假说。本研究提出，转化研究联盟可作为开发用于对抗被忽视热带病（neglected tropical diseases, NTDs）的药物递送系统的潜在替代方案。