Peptinnovate's exploitation of molecules derived from M.tuberculosis bacteria: The development of a prototype for treating acute inflammatory disease

结核病（TB）细菌存在于全世界约20亿人中;它们已经进化了1000多年，通过产生调节宿主免疫系统的蛋白质来隐藏在体内。Peptinnovate的创新Peptinnovate的方法是解锁这些蛋白质的抗炎活性，并通过进化和自然的独创性将这些蛋白质改造成更像药物的分子，开发用于急性器官衰竭和慢性阻塞性肺病（COPD）等衰弱性疾病的新药。目的：该项目将使我们的先导分子PIN 201104能够在初步的非临床研究中合成、配制和测试，用于静脉注射的急性使用。除此之外，我们还将在一系列炎症疗效模型中进行体内疗效研究，以扩大该分子的治疗效用。生产足量的活性物质以进行拟定研究，为了制备和稳定性试验拟用于拟定研究的制剂，？进行初步毒理学研究，包括在第二种属中进行试验、遗传毒性、免疫原性试验和安全药理学研究，？进行明确的大鼠和狗DMPK研究，？为了证明在一系列炎症动物模型中的有效性，以扩展PIN 201104的临床适应症范围，主要益处，可能的结果和影响炎症性疾病治疗的全球市场是巨大的（> 700亿美元），然而最近的安全性恐慌归因于一些关键药物。Peptinnovate在潜在治疗选择方面的巨大转变将对数百万患者的生活产生深远的影响，减轻医疗保健提供者的负担，并帮助建立一家可持续的英国制药公司。

Tuberculosis (TB) bacteria are present in about 2 billion people worldwide; they have evolvedover 1000’s of years to remain hidden in the body by producing proteins that modulate thehost's immune system. These proteins have been shown to interact with and reduce the body'snatural inflammatory processes.Peptinnovate’s innovationPeptinnovate’s approach is to unlock the anti-inflammatory activity of these proteins and todevelop new medicines for debilitating diseases such as acute organ failure and chronicobstructive pulmonary disease (COPD) by building on evolution and nature's ingenuity tomodify these proteins to more drug-like molecules.Aims:This project will enable our lead molecule PIN201104 to be synthesised, formulated andtested in preliminary non-clinical studies for acute use via the intravenous route. Alongsidethis we will also carry out in vivo efficacy studies in a range of inflammatory efficacy modelsto widen the therapeutic utility of the molecule.Objectives:? To manufacture active substance in sufficient quantities to perform proposed studies,? To prepare and stability test a formulation to be used in the proposed studies,? To perform preliminary toxicology studies to include testing in a second species,genotoxicity, immunogenicity assays and safety pharmacology studies,? To perform definitive rat and dog DMPK studies,? To demonstrate efficacy in a range of animal models of inflammation to extendPIN201104 range of clinical indications,Main benefits, likely outcomes and impactsThe worldwide market for inflammatory disease treatment is substantial (>$70 billion),however recent safety scares have been attributed to a number of key drugs. Peptinnovate’sparadigm shift in potential treatment options will have a profound impact on the lives ofmillions of patients, reducing the burden on the healthcare providers and helping to build asustainable, UK based pharmaceutical company.