ELIXERA, INC. — Department of Health and Human Services SBIR Phase I: 200

Description

Cortisol is a steroid hormone that regulates a wide range of processes throughout the bodyincluding metabolism and the immune responseIt also has a very important role in helping the body respond to stressHigh levels of adrenocorticotropic hormoneACTHin the adrenal glands stimulate the secretion of cortisolcausing blood levels of cortisol to riseToo much cortisol for a long period of time leads to a condition called Cushing s syndromecharacterized by rapid weight gain mainly in the facechest and abdomen contrasted with slender arms and lega flushed and round facehigh blood pressureosteoporosisskin changesmuscle weaknessmood swings that show as anxietydepression or irritability and increased thirst and frequency of urinationWhen Cushing s syndrome is caused by a tumor of the pituitary gland that secretes too much ACTHthe condition is known as Cushing s diseaseFor reasons that are unclearCushing s disease affects women more often than men by almosttoWomen with Cushing s disease may experience irregular menstruation and have excessive hair growth on their faceabdomenand legsLeft untreatedCushing s disease can be deadlyand the preferred course of action is to surgically remove the tumor without damaging the rest of the pituitary glandWhen surgery is not possible or fails to completely remove the tumormedication is often needed to block the effects of the excess cortisolWhile steroid synthesis inhibitorsglucocorticoid receptor blockerscabergolineand somatostatin analogs have certainly made a great difference in the care of patients with Cushing s diseasea substantial number of these patients are never adequately treatedThere is a clear unmet medical need for novel treatments with better control of the disease and fewer side effectsWe propose an antibody therapeutic as a novel approach to controlling excess cortisol that we believe can act across the entire patient population and that can work in concert with other medicationsOur goal for this SBIR NIH grant is to initiate the necessary development work to make this new medicine possible While steroid synthesis inhibitorsglucocorticoid receptor blockerscabergolineand somatostatin analogs have made a great difference in the care of patients with Cushing s diseasea substantial number of these patients are never adequately treatedThere are a handful of new treatments on the horizonbut most areme toodrugs that are unlikely to be more effective than what is currently availableWe are proposing a novel antibody approach to treating Cushing s disease across the entire spectrum of the patient population