On September 2, 2022 Crinetics Pharmaceuticals reported that Monica R. Gadelha, MD, PhD, professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro and a principal investigator in the Phase 2 ACROBAT program, will be presenting data from a planned two-year interim analysis from the ACROBAT Advance open label extension (OLE) study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM) being held in São Paulo, Brazil from September 3-7, 2022 (Press release, Crinetics Pharmaceuticals, SEP 2, 2022, View Source [SID1234618942]).
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DETAILS OF THE ORAL PRESENTATION IS AS FOLLOWS:
Congress: Brazilian Congress of Endocrinology and Metabolism (CBEM)
Title: Paltusotine shows long-term safety and IGF-1 maintenance in the ACROBAT Advance study
Date/Time: September 4, 2022 at 3:30 pm BST / 2:30 pm EDT
Enrollment in the Advance OLE study was offered to participants from the Phase 2 ACROBAT Evolve and Edge studies of acromegaly patients who were under a variety of degrees of baseline biochemical control as defined by insulin-like growth factor-1, or IGF-1, levels when treated with regimens that included an injected somatostatin receptor ligand (SRL).
ABOUT ACROMEGALY
Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. Excess GH secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms and physical manifestations of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism. Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands (SRLs) are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.
ABOUT PALTUSOTINE
Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2). It was designed by the Crinetics discovery team to provide a once-daily oral option for patients with acromegaly and neuroendocrine tumors. A previously completed Phase 1 trial of paltusotine showed clinical proof of concept by providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.