BACKGROUND Company: Mid-sized pharmaceutical company Therapeutic area: Endocrine and Metabolic Disease Indication: Hypophosphatemia Phase: II and III CHALLENGE The sponsor was running six studies for a compound to treat the rare genetic disorder hypophosphatemia, spanning more than 40 global study sites. Hypophosphatemia is an abnormally low level of phosphate in the blood that can cause morbidities such as a bone softening, fatigue, muscle weakness, and slowed growth that may ultimately result in a person attaining a much shorter than average height. The compound being tested has the potential to cause adverse cardiovascular effects. The sponsor was particularly sensitive to the possibilities of ectopic mineralization (i.e., deposits of calcium and other minerals in soft tissues —

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