– If successful, paltusotin would offer patients with acromegaly a once-daily oral treatment option –
SAN DIEGO, June 28, 2021 (GLOBE NEWSWIRE) – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of new treatments for rare endocrine diseases and tumors related to the endocrine system, today announced the randomization of the first patient with acromegaly in its Phase 3 clinical trial with paltusotin, PATHFNDR-1. This trial will be one of two planned Phase 3 studies evaluating the safety and efficacy of once-daily oral paltusotin in patients with acromegaly who together will evaluate paltusotin in a large sample of patients with acromegaly. acromegaly. If successful, Crinetics believes its Phase 3 program could support the registration of paltusotin in the United States and Europe for all patients with acromegaly requiring drug therapy.
“The assay of the first patient in the PATHFNDR program represents a key step in the clinical development of paltusotin. We believe that if successful, these trials would support the approval of paltusotin as the first oral non-peptide alternative to the standard of care injected for the treatment of acromegaly, ”said Alan Krasner, MD, medical director by Crinetics. “Our goal for paltusotin is to provide a once-daily oral option for patients with acromegaly that can help control excessive hormone levels while relieving the burden and pain of currently available therapies.”
“This is the first product candidate in our emerging endocrine pipeline to reach Phase 3 clinical trials. I am very proud of the team that created paltusotin and facilitated its development to this point,” added Scott Struthers, Ph.D., Founder and CEO of Crinetics. “We are now focused on completing these trials and, if approved, making paltusotin available to patients with acromegaly worldwide. At the same time, we remain committed to advancing our pipeline of non-peptide product candidates for endocrine patients and investing in our small molecule discovery approach to further develop this pipeline. “
About the PATHFNDR-1 study
PATHFNDR-1 (NCT04837040) is expected to recruit 52 patients with acromegaly who are biochemically controlled i.e. insulin-like growth factor-1 (IGF-1) x 1.0 times the limit higher than normal (ULN), under monotherapy with octreotide or lanreotide-depot. After a screening period, during which baseline values for IGF-1, growth hormone (GH), and total acromegaly symptom diary score will be determined, participants will be randomized 1 to 1. to receive oral paltusotine or placebo once a day for nine months. . The primary endpoint of PATHFNDR-1 will be the proportion of patients who are biochemically controlled in weeks 32-36. For statistical success on the primary endpoint of the trial, paltusotin must demonstrate superiority over placebo in this responder analysis. All eligible patients will have the opportunity to participate in an open-label extension study after the end of the PATHFNDR-1 treatment period. The first data from the PATHFNDR-1 trial should be available in 2023.
Acromegaly is a serious disease usually caused by a pituitary adenoma, a benign tumor of the pituitary gland that secretes growth hormone. Excessive secretion of GH causes excessive secretion of IGF-1 by the liver. Together, the excess of these hormones leads to the doctor’s symptoms and manifestations of acromegaly, including abnormal growth of hands and feet, altered facial features, arthritis, carpal tunnel syndrome, joint pain, deepening of the voice due to enlarged vocal cords, fatigue, sleep apnea, enlarged 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 patients with acromegaly. Pharmacological treatments are used for patients who are not candidates for surgery or when surgery fails to meet treatment goals. About 50% of patients with acromegaly are candidates for pharmacological treatment. Long-acting somatostatin receptor ligands (SRLs) are the most common initial pharmacological treatment, but these drugs require monthly depot injections with large-gauge needles which are usually associated with pain, reactions. at the injection site and the increased burden of treatment on the life of patients.
Paltusotin is an experimental, orally available, non-peptide agonist designed to be highly selective for the somatostatin type 2 receptor (SST2). It was designed by the Crinetics Discovery Team to provide a once-daily option for patients with acromegaly and neuroendocrine tumors. A previously completed phase 1 trial of paltusotin has shown clinical proof of concept providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In phase 2 trials, paltusotin maintained IGF-1 levels in patients with acromegaly who switched from depot injectable drugs to oral paltusotine once daily. IGF-1 is the primary biomarker used by endocrinologists to manage their patients with acromegaly.
About Crinetics Pharmaceuticals
Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapies for rare endocrine diseases and endocrine-related tumors. The Company’s lead product candidate, paltusotin, is an experimental, oral and selective non-peptide somatostatin type 2 receptor agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. . A phase 3 program to evaluate the safety and efficacy of paltusotin for the treatment of acromegaly is underway. Crinetics also plans to advance paltusotin into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. The company is also developing CRN04777, an experimental, oral, non-peptide somatostatin type 5 receptor (SST5) agonist for congenital hyperinsulinism, as well as CRN04894, an experimental oral and non-peptide ACTH antagonist for treatment of Cushing’s disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the Company’s drug candidates are new chemical entities resulting from internal drug discovery efforts and are wholly owned by the Company.
Crinetics cautions you that statements in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the current beliefs and expectations of the company. These forward-looking statements include, without limitation, statements regarding: the potential of the PATHFNDR program to support the registration of paltusotine in the United States and Europe for all patients with acromegaly requiring drug therapy; the expected baseline data schedule for the PATHFNDR-1 trial; plans to advance paltusotin into a phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors; and plans to advance other product candidates and invest in the small molecule discovery approach. The inclusion of forward-looking statements should not be taken as a representation by Crinetics that any of its plans will be realized. Actual results may differ from those presented in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: the FDA or other regulatory agencies may require one or more clinical trials additions to paltusotin or suggest modifications to Crinetics’ planned Phase 3 clinical trials prior to and in support of the approval of a new drug application or the applicable foreign regulatory approval; advancement of paltusotin into a phase 2 trial for carcinoid syndrome is dependent on and subject to receipt of further comment from the FDA; the COVID-19 pandemic may disrupt the business of Crinetics and those of third parties on which it depends, including by delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or by affecting employee productivity; the company’s dependence on third parties for product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials and non-clinical studies for paltusotin, CRN04894, CRN04777 and its other product candidates; regulatory developments in the United States and in foreign countries; unexpected adverse side effects or inadequate efficacy of the Company’s product candidates which may limit their development, regulatory approval and / or commercialization; Crinetics can use its capital resources sooner than expected; and other risks described under “Risk Factors” in documents that the Company files from time to time with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Crinetics makes no commitment to update such statements to reflect events that occur or circumstances that occur. exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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