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SAN DIEGO, September 4, 2020 (GLOBE NEWSWIRE) – Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a pharmaceutical company based on clinical-stage discoveries, today announced the progression and commercialization of new treatments for rare endocrine diseases and tumors. endocrine. that it has been decided to make a presentation on orally administered small molecule adrenococcal hormone (ACTH) antagonist for a last minute consultation at the Virtual European Congress of Endocrinology (eECE) on September 8, 2020. The effects of Phase 1 bioavailability studies of paltusotin (formerly CRN00808), the company’s leading candidate for the acromegaly remedy, will be available to delegates from September 5-9, 2020.
Crinetics develops an ACTH antagonist for the remedy of diseases related to excess ACTH, such as Cushing’s disease and congenital adrenal hyperplasia (CAH).In the provision of eECE, Crinetics will provide knowledge that one of a number of experimental ACTH antagonists reduced corticosteroid grades and had a positive effect on the size, morphology and function of the adrenal glands after seven days of repeated dosing in a rat model with excess ACTH.Based on these favorable in vivo preclinical results, Crinetics plans to advance its main ACTH antagonist in single upstream doses (SAD) and multiple-dose ascending Phase 1 (MAD) studies in healthy volunteers delayed in 2020 or early 2021.
“Our drug candidate is prepared to be the first ACTH antagonist to introduce clinical progression for the remedy of diseases caused by excess ACTH, adding Cushing and CAH disease,” explained Alan Krasner MD, medical director of Crinetics.The peptide drug can have a very significant effect on those patients for whom the characteristics of the remedy are limited.We look forward to taking the next step in this program by moving our main ACTH candidate antagonist to Phase 1.»
In addition, in a poster presentation at the eECE, Crinetics will provide the effects of a Phase 1 study indicating that paltusotin provided a favorable mean oral bioavailability of 70%.In addition, no abundant circulating metabolites of paltusotin have been identified.Adverse occasions related to paltusotin were sometimes mild and brief and coincided with those reported with other somatostatin agonists.The effects of this study recommend that paltusotine has adequate properties for chronic oral treatment once daily in patients with acromegaly.
In April 2020, Crinetics published the provisional effects of an exploratory investigation of the first thirteen patients who participated in the ACROBAT Edge Phase 2 trial in octreotide or lantreotide deposition monotherapy, which showed that at the deadline, changing oral paltusotin once daily maintained IGF .-1 degrees to those received with an earlier deposit.Paltusotine was well tolerated and the side effects observed were similar to those of other somatostatin agonists.There was no discontinuation for adverse events related to the drug, and the maximum of non-unusual side effects.Sometimes remedy occurred (up to 10%) headaches, arthralgia, peripheral swelling, back pain and hyperhidrosis.
Scott Struthers, Ph.D., Founder and CEO of Crinetics, added: “We look forward to reporting on the key effects of ACROBAT’s knowledge set in the fourth quarter of this year.At that time, we hope to have more complete picture of the pharmacokinetic and clinical profile of paltusotin, adding the ability to maintain IGF-1 grades after converting patients from their previous remedy through the deposition of somatostatin receptor ligaments.»
The poster and oral presentations will be available www.crinetics.com after the conclusion of the eECE meeting.In the ECE virtual environment, they are:
1)
Effects of oral bioavailable non-peptide ACTH antagonists on the length and function of the adrenal glands in rats: September 8, 2020 at 1:15 p.m.CET.Oral Communications 6 – Last Minute Summary – Channel 3.
2)
Absolute bioavailability and oral absorption, metabolism, excretion of paltusotin marked with [14C] (CRN00808), a sessed receptor 2 agonist of somatostatin (sst2) bioavailable orally, non-peptide, selective for acromegaly remedy: September 5, 2020 of 01 : 00 – 19: 0five CET.ePósters: pituitary and neuroendocrinology.
In addition to previous eECE presentations, Crinetics will conduct a consultation of the Centre entitled: New Frontiers in Endocrine Research on September 9 at 08:00 CET, in which Dr. Krasner will give a review of Crinetics and its on-the-go programs.to all fitness professionals registered for eECE 2020.For more information, visit the ERC website: ese-hormones.org/e-ece-2020.
About paltusotin Paltusotin (formerly CRN00808) is a non-polarized oral agonist, designed to be highly selective for somatostatin type 2 (sst2) receptor. It was designed through the Crinetics Discovery Team to provide a once-a-day option for patients.with acromegaly and neuroendocrine tumors that are currently being treated with injected treatments sold for around $3.1 billion a year Non-clinical studies of chronic toxicology have been completed and no dose-limiting toxicity has been known at maximum doses that can be had in rats and Kinetics in the past ended a phase 1 trial that showed strong suppression of the expansion hormone axis (GH) in volunteers provided evidence of the clinical concept.In addition, the observed plasma half-life of the molecule of approximately 2 days advised paltusotin leaflets for oral treatment once daily.A next phase 1 trial showed that paltusotin is 70% biological orally.
Acromegaly Acromegaly is a serious disease regularly caused by a benign tumor that secretes an expansion hormone in the pituitary gland.Excessive GH secretion causes superior insulin-1-like expansion (IGF-1) to secrete through the liver, What Causes Bones and Cartilaginous Proliferation, Enlarged Organs and Adjustments in Glucose and Lipid Metabolism The symptoms of acromegaly come with the expansion of the hands and feet and adjustments in the shape of bones and cartilage that alter facial features Proliferation of enlarged bones and cartilage and thickening of the effects of tissues on arthritis, carpal tunnel syndrome, enlarged joint, nose and tongue, more severe voice due to enlarged vocal cords, sleep apnea due to airway obstruction and enlarged center, liver and other organs.
Surgical removal of pituitary adenomas, if possible, is the preferred initial remedy for patients with acromegaly.Pharmacological remedies are used for patients who are not applicants for surgery or when surgery does not achieve the goals of the remedy.Approximately 50% of patients with acromegaly are Long-acting somatostatin receptor ligandos (LRS) are sometimes the initial pharmacological remedy, however, these medications require monthly injections and are sometimes related to pain, injection site reactions and a higher burden on patients’ lives.more than 90% of patients have demonstrative responses to SRL (Annals of Internal Medicine) .1992; 117: 711-718), only 20 to 40% of patients achieve the normalization of IGF-1 (J Clin Endocrinol Metab 99: 791-799, 2014).Additional features of pharmacological remedies come with dopamine agonists or GH receptor antagonists that can be used in mixture with LRS.
About Cushing’s disease and congenital adrenal hyperplasia Cushing’s disease is an orphan indication with a prevalence of approximately 12,000 patients in the United States.It occurs much more in women, and sometimes between the age of 30 and 50.Cushing’s disease occasionally takes several years to diagnose and would possibly be underdiagnosed in the general population due to many of its symptoms such as lethargy, depression, obesity, etc.hypertension, hirsutism and irregularity. The era can be mistakenly attributed to other, more common disorders.
CAH encompasses a set of disorders caused by genetic mutations that result in an alteration of cortisol synthesis; this lack of cortisol leads to a breakdown of the feedback mechanisms and leads to constantly high degrees of ACTH, which in turn causes overstimulation of the adrenal cortex.Superior secretion of other steroids (especially androgens) and steroid precursors can cause a variety of adverse effects, adding atypical genital development, early puberty, expansion and infertility.HAC occurs in 1 in 13,000 to 1 in 15,000 live births.
About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a clinical-stage pharmaceutical company dedicated to the discovery, progression, and commercialization of novel treatments for rare endocrine diseases and endocrine tumors. The company’s main candidate product, paltusotin (formerly CRN00808), is an oral selective agonist unbiased by peptides of the somatostatin type 2 receptor in two phase 2 clinical trials for the remedy of acromegaly, an orphan disease affecting the more than 250,000 people in the United States. Crinetics plans to advance paltusotin to a phase 3 trial in acromegaly and a phase 2 trial for the remedy of NET-related carcinoid syndrome in 2021. The company will also introduce an oral non-peptide agonist of the somatostatin type five receptor ( sstfive) for hyperinsulinism. as an oral non-peptide ACTH antagonist for the remedy of Cushing’s disease, congenital adrenal hyperplasia and other ACTH excess diseases. All of the Company’s drug applicants are new chemical entities that result from internal drug discovery efforts and are owned one hundred percent through the Company. For more information, visit www.crinetics.com.
Forward-Looking Statements Crinetics advises you that statements in this press release relating to matters that are not old facts are forward-looking statements. These statements are based on the existing ideals and expectations of society. These forward-looking statements include, but are not limited to, statements regarding: the potential for the Crinetics ACTH antagonist to have a significant effect on patient care; the option to initiate phase 1 trials with Crinetics’ number one ACTH antagonist and timing; the possibility that paltusotin is an effective remedial option for patients with acromegaly; the option that the intermediate knowledge effects are consistent with the final effects, once available; the ability of one of our ongoing clinical trials to demonstrate protection or efficacy; the feasibility and timing of a pivotal phase 3 trial of paltusotin in acromegaly; and the expected lead knowledge schedule for the ACROBAT Phase 2 tests. The inclusion of forward-looking statements is not to be taken as a representation by Crinetics that any of its plans will be achieved. Actual effects may differ from those stated in this press release due to threats and uncertainties inherent in Crinetics’ business, adding, but not limited to: the threat that the interim effects of a clinical trial do not necessarily anticipate the final effects and one or more of the clinical effects would possibly be repositioned, particularly as patient recruitment continues, as a result of more comprehensive knowledge reviews, and as more patient knowledge becomes available; possible delays in the start-up, recruitment and finishing touch of clinical trials and the reporting of similar knowledge; the advancement of paltusotin in a phase 3 trial and Crinetics’ number one ACTH antagonist in phase 1 trials are cleansing and subject to additional comment from FDA; the COVID-19 pandemic is likely to disrupt Crinetics’ business and those of third parties it defines upon, adding delays or otherwise disrupting its clinical trials and preclinical studies, supply chain and supply, or adversely affecting worker productivity; the definition of the company vis-à-vis third parties for the production of products, research and clinical and preclinical trials; the good luck of Crinetics’ clinical trials and non-clinical studies with paltusotin, its ACTH antagonist, and other product applicants; regulatory advances in the United States and in foreign countries; unforeseen adverse effects or insufficient efficacy of applicants for the Company’s products that could possibly restrict their development, regulatory approval and / or commercialization; Crinetics can use its capital resources faster than expected; and other threats described in “Risk Factors” in documents that the Company periodically submits to the Securities and Exposure Commission. You are cautioned not to place undue reliance on such forward-looking statements, which refer only to the date hereof, and Crinetics assumes no legal responsibility to update such statements to reflect occurrences or occurrences. they exist after the date hereof. All forward-looking statements are qualified in their entirety through this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media:
Marc Wilson
Aline Sherwood
Chief Financial Officer
Scienta Communications
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