The IND Approval From The FDA, Experimental Acromegaly Drug Will Enter Phase 3 Trials

According to a story from Markets Insider, the biopharmaceutical company Camurus has recently issued an announcement indicating that the US Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CAM2029. This investigational product candidate is being developed to treat the rare condition acromegaly. With the acceptance of the IND, the company will now begin the initiation of a phase 3 clinical trial. Camurus is dedicated to the development of long acting therapeutics for chronic, severe disorders.

About Acromegaly

Acromegaly is a condition that is characterized by the excessive release of growth hormone in the body after the growth plates have already closed. The disease is caused by overproduction of growth hormone by the pituitary gland, which usually occurs as a result of a tumor of the pituitary gland or of another organ in the body, such as the lungs or adrenal glands. Symptoms include enlargment of the feet, hands, nose, jaw, and forehead, deepening voice, and thick skin. The condition can occasionally cause serious complications like heart or kidney failure, colorectal cancer, diabetes, and high blood pressure. Treatment may include radiation therapy, surgical removal of the tumor, and a number of medications to suppress growth hormone production. Most people see their symptoms disappear after successful treatment, and life expectancy is not affected. To learn more about acromegaly, click here.

The phase 3 clinical trial will have a treatment period lasting 24 weeks. This trial will include a total of 50 trial sites distributed throughout both Europe and the US. Completion of the trial is projected for early in 2021.

About CAM2029

CAM2029 is a long-acting “depot” meant to be placed under the skin that consists of octreotide, which is a synthetic analogue of the naturally occurring hormone somatostatin. The depot comes “ready to use” and can be self-administered by the patient. The treatment also displays greater bioavailability of octreotide in comparison to currently available treatment methods. Camurus hopes to develop CAM2029 for the treatment of both acromegaly and neurofibromatosis. Prior trials with the treatment have shown encouraging results so far and the CAM2029 has earned orphan designation from the European Commission. 


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