Late preclinical development of a treatment for acute inflammatory disease derived from M.tuberculosis bacteria

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Tuberculosis bacteria (mTB) are present in about 2 billion people worldwide; they haveevolved over millennia 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 COPD.Building on evolution, nature's ingenuity and employing Peptinnovate’s drug discovery anddevelopment skills we have modified these proteins to more drug-like molecules and areprogressing the candidate molecule, PIN201104, to the clinic.AimsFollowing scientific advice and approval from the MHRA and previous SMART support(720364), this project will enable our drug candidate, PIN201104, to be evaluated in GLP nonclinicaltoxicology studies, and manufactured and formulated to GMP standards for acute usevia intravenous dosing. Alongside this we will also carry out further in vivo efficacy studies ina range of inflammatory disease models to widen the therapeutic utility of the molecule.Objectives• To perform MHRA approved GLP toxicology and safety pharmacology studies in therat and dog,• To manufacture and evaluate PIN201104 drug substance and drug product to GMPstandards ready for clinical studies,• To demonstrate efficacy in a range of animal models of inflammation to extendPIN201104’s range of clinical indications.Benefits, 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.