Project Summary: Acromegaly is a chronic, rare endocrine disorder that affects approximately 21,000 adults in the US that is most often caused by a non-cancerous pituitary tumor that secrets excess growth hormone. Left untreated, chronic overproduction of growth hormone and subsequent stimulation of insulin-like growth factor-1 in other tissues shortens the the average life expectancy by 10 years from diagnosis. The disease is associated with 2- to 3-fold increased mortality and serious health complications and comorbidities. These include cardiovascular disease, respiratory disorders, and metabolic diseases such as type 2 diabetes and impaired lipid metabolism. The broad consensus is that effective treatment is achieved by strict growth hormone control, demonstrated by the beneficial effects on comorbidities and mortality. When surgery either fails to completely remove the pituitary adenoma or is not an option, medical therapy is required for long-term hormone control. However, control is achieved in only half of patients by the existing therapies. There is a clear unmet medical need for a therapy that achieves long-term hormone control consistently across the acromegaly patient population. Elixera’s goal is to develop a novel therapeutic as a first-in-class treatment of acromegaly that fulfills this unmet medical need. In Phase 1 of this grant, we identified a novel antibody therapeutic that was highly potent in blocking growth hormone activity. The aim of the Phase 2 grant is to prepare the therapeutic candidate for manufacture and preclinical toxicology studies and begin clinical trial testing in acromegaly patients.