Development of a novel antibacterial agent against Pseudomonas aeruginosa

菲科正在开发一种名为SASPject的新型抗菌技术，可以针对特定的有害细菌。SASPject不受抗生素耐药机制的影响，并以细菌无法避免的方式使细菌DNA失能。该项目将使菲科完成针对铜绿假单胞菌（Pa）的SASPject PT3的临床前开发。Pa对许多抗生素具有内在耐药性，由于广泛的感染，在2010年造成了约4000万天的住院治疗。在这个为期18个月的项目中，菲科将扩展疗效数据，以确定人类的最佳剂量策略。菲科还将开发一种15L的生产工艺，然后将该工艺转让给合同制造商，后者将扩大到50L的gmp准备工艺，并生产用于安全研究的材料。冻干工艺也将被开发。该项目期间进行的安全性研究将提供足够的数据支持临床试验申请，使SASPject PT3准备在I期试验中进行测试。

Phico is developing a novel antibacterial technology called SASPject, that can be targeted to selected harmful bacteria. SASPject is not affected by antibiotic resistance mechanisms and works by disabling bacterial DNA in a way that bacteria cannot avoid. This project will enable Phico to complete the pre-clinical development of SASPject PT3 targeted to Pseudomonas aeruginosa (Pa). Intrinsically resistant to many antibiotics, Pa caused ~40M days of hospital therapy in 2010 due to a wide range of infections. In this 18 month project Phico will extend efficacy data to determine the best dosing strategy in humans. Phico will also develop a manufacturing process to 15L and then transfer the process to a contract manufacturer who will scale up to a 50L GMP-ready process and produce material for a safety study. A lyophilisation process will also be developed. The safety study conducted during this project will provide sufficient data to support a clinical trial application, making SASPject PT3 ready to test in a Phase I trial.