10142740Commercialising a non-GLP-1 approach to metabolic disease managementActiveCollaborative R&DInnovate UKDia Beta Labs (DBL) is a **UK-based biotech company** devoted to **tackling the worsening global metabolic disease crisis**, which is driven by uncurbed growth of obesity and diabetes. DBL has developed selective lead molecules against its lead target, a novel receptor in metabolic disease. Our data to date indicates that our leads have the potential to **transform patient outcomes over current standards of care**, namely GLP-1R agonists such as Ozempic. In particular, DBL leads **favour fat loss over muscle loss**, which is a major clinical advantage. This occurs through direct actions on brown fat and indirectly through reduction of appetite and greater disposal of sugar in the blood. These effects are a result of the presence and function of our receptor of interest on multiple metabolic tissues. First-generation, currently available obesity therapeutics, targeting the GLP-1 pathway, have proved popular but have limitations, including l**ack of discrimination between muscle and fat loss**. In addition to growing concern around muscle loss, they frequently cause severe **gastrointestinal side-effects**, culminating in discontinuation of these therapeutics in 70% of patients by 24-months. **No suitable, non-GLP-1, alternative exists presently**. Thus, there is considerable need for new, effective and well tolerated therapeutics for obesity management. This project builds upon our success in validating our novel target, and development of our selective, well-tolerated lead molecules. Whilst we have built a **strong efficacy validation data package**, which has been of **considerable interest to potential Pharma partners**, our manufacture has only been performed at small-scale and to non-Good Manufacturing Practice (GMP) standards, while our animal experiments have been performed in-house rather than at an accredited. Good Laboratory Practice (GLP) site. Through this project, we will address both of these requirements to **increase favourability to regulators** ahead of a first-in-human trial application for our lead therapeutic. All studies are designed in adherence to National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) guidance ensuring **all research is ethical** and performed with the minimum number of animals possible.