New Long-Term Safety and Efficacy Data for Investigational Compound Paltusotine to be Presented at the Brazilian Congress of Endocrinology and Metabolism

Rhea-AI Summary

Crinetics Pharmaceuticals (CRNX) announces that Dr. Monica R. Gadelha will present interim data from the ACROBAT Advance open label extension study at the 35th Brazilian Congress of Endocrinology and Metabolism (CBEM) on September 4, 2022. The presentation highlights paltusotine's long-term safety and maintenance of IGF-1 levels in acromegaly patients transitioning from injectable therapies. Paltusotine is an investigational oral treatment designed to selectively target somatostatin receptor type 2, aiming to improve patient compliance and outcomes.

Positive

• Paltusotine shows long-term safety and maintenance of IGF-1 levels, indicating its potential effectiveness in treating acromegaly.
• Paltusotine provides a once-daily oral treatment option, which may improve patient compliance compared to monthly injections.

Negative

• None.

SAN DIEGO, Sept. 02, 2022 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals (Nasdaq: CRNX) today announced 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 35^th Brazilian Congress of Endocrinology and Metabolism (CBEM) being held in São Paulo, Brazil from September 3-7, 2022.

Details of the oral presentation is as follows:

Title:		Paltusotine shows long-term safety and IGF-1 maintenance in the ACROBAT Advance study
Congress:		Brazilian Congress of Endocrinology and Metabolism (CBEM)
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.

About Crinetics Pharmaceuticals
Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. Paltusotine, a somatostatin receptor type 2 (SST2) agonist, is in Phase 3 clinical development for acromegaly and Phase 2 clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics has demonstrated pharmacologic proof-of-concept in Phase 1 clinical studies for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist for congenital hyperinsulinism, and for CRN04894, an investigational, oral ACTH antagonist for the treatment of Cushing’s disease, congenital adrenal hyperplasia, and other diseases of excess ACTH. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts.

Contacts:
Chas Schultz
VP, IR & Corporate Communications
cschultz@crinetics.com
(858) 450-6464

Investors / Media:
Corey Davis
LifeSci Advisors, LLC
cdavis@lifesciadvisors.com
(212) 915-2577

Aline Sherwood
Scienta Communications
asherwood@scientapr.com
(312) 238-8957

FAQ

What will Dr. Monica R. Gadelha present at the CBEM 2022?

Dr. Gadelha will present data from the two-year interim analysis of the ACROBAT Advance study.

When is the presentation scheduled?

The presentation is scheduled for September 4, 2022, at 3:30 pm BST / 2:30 pm EDT.

What is paltusotine designed to treat?

Paltusotine is designed to treat acromegaly and neuroendocrine tumors.

What is the significance of IGF-1 levels in acromegaly?

IGF-1 levels are a primary biomarker used to manage treatment in acromegaly patients.

What is the focus of Crinetics Pharmaceuticals?

Crinetics focuses on developing therapeutics for rare endocrine diseases and endocrine-related tumors.