Development of a novel antibacterial agent against Pseudomonas aeruginosa

Phico正在开发一种名为SASPject的新型抗菌技术，该技术可以针对选定的有害细菌。SASPject不受抗生素耐药性机制的影响，其工作原理是以细菌无法避免的方式禁用细菌DNA。该项目将使Phico能够完成针对铜绿假单胞菌(PA)的SASPject PT3的临床前开发。由于对许多抗生素具有内在抗药性，PA在2010年因广泛的感染而导致约4000万天的医院治疗。在这18个月的项目中，Phico将扩展疗效数据，以确定在人类身上的最佳剂量策略。Phico还将开发一种15L的制造工艺，然后将该工艺转移给合同制造商，后者将扩大到50L GMP就绪工艺，并为安全研究生产材料。还将开发一种冷冻干燥工艺。在该项目期间进行的安全性研究将提供足够的数据来支持临床试验应用，使SASPject PT3准备好在第一阶段试验中进行测试。

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.