Crinetics Pharmaceuticals, Inc.<\/u><\/a> (Nasdaq: CRNX) today announced that the first patient has been dosed in the CALM-CAH Phase 3 trial evaluating investigational candidate atumelnant, a novel, once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate for the proposed treatment of classic congenital adrenal hyperplasia (CAH).<\/p>\n \u201cDosing the first patient in this Phase 3 study underscores our commitment to addressing the unmet needs of people living with CAH and our excitement about the potential of atumelnant,\u201d said Dana Pizzuti, M.D., Chief Medical and Development Officer of Crinetics. \u201cThrough the CALM-CAH study, we will evaluate atumelnant\u2019s ability to normalize adrenal androgen levels while simultaneously reducing glucocorticoid levels to the physiologically normal range. With a unique endpoint measuring both of these objectives, CALM-CAH sets a new standard in terms of assessing overall disease control.\u201d<\/p>\n Atumelnant is the first-and-only small molecule ACTH receptor antagonist in late-stage clinical development and is designed to block the pathway in the adrenal gland that leads to the production of excess androgens associated with classic CAH. In a Phase 2 study in adults with classic CAH, treatment with atumelnant was associated with reductions in key biomarkers, including androstenedione and 17-hydroxyprogesterone, as well as other clinical measures of disease activity including adrenal size and resumption of menses. Based on Phase 2 results, Crinetics has advanced the registrational CALM-CAH Phase 3 trial in adults.<\/p>\n The CALM-CAH Phase 3 study is a randomized, placebo-controlled trial evaluating atumelnant in adults with classic CAH, designed to assess reductions in excess androgens, improvements in glucocorticoid use, and other clinical outcomes that reflect disease control.<\/p>\n Crinetics recently received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) for atumelnant in the treatment of classic CAH.<\/p>\n For more information, visit https:\/\/clinicaltrials.gov\/study\/NCT07159841<\/a>.<\/p>\n Investigational atumelnant is the first in class and only once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland in late-stage clinical development. Diseases associated with excess ACTH can have a significant impact on physical and mental health. Novel atumelnant has exhibited strong binding affinity for MC2R in preclinical models and has demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH. Data from a 12-week Phase 2 study consistently demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH disease related biomarkers, including A4 and 17-hydroxyprogesterone, in a diverse population. Currently in Phase 3 clinical development, atumelnant holds the potential to offer transformational care for individuals living with congenital adrenal hyperplasia and ACTH-dependent Cushing\u2019s syndrome. This breakthrough could revolutionize the management of these conditions, providing hope for unprecedented improvements in quality of life.<\/p>\n Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.<\/p>\n Crinetics\u2019 lead product, PALSONIFY\u2122\u00a0(paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA for the treatment of adults with acromegaly who had an inadequate response to surgery and\/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics\u2019 deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing\u2019s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat SST2 expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs address a variety of endocrine conditions such as neuroendocrine tumors, Graves\u2019 disease (including Graves\u2019 hyperthyroidism and Graves\u2019 orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications.<\/p>\n Forward-Looking Statements<\/strong> Statement issued by the company (Announcement) Phase 3 study builds on positive phase 2 results showing rapid and sustained reductions in key disease biomarkers and clinical measures of CAH. Crinetics […]<\/p>\n","protected":false},"author":198164071,"featured_media":48434,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[125518],"tags":[],"class_list":["post-201085","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globenewswire-en"],"acf":[],"yoast_head":"\nAbout Atumelnant<\/h2>\n
About Crinetics Pharmaceuticals<\/h2>\n
\nThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the Phase 3 program for atumelnant for CAH and for a Phase 2\/3 program of atumelnant for ACTH-dependent Cushing\u2019s syndrome; the plans and timelines for the clinical development of our drug candidates, including the therapeutic potential and clinical benefits or safety profile thereof or the expected timing of the advancement of those programs. In some cases, you can identify forward-looking statements by terms such as \u201cmay,\u201d \u201cwill,\u201d \u201cshould,\u201d \u201cexpect,\u201d \u201cplan,\u201d \u201canticipate,\u201d \u201ccould,\u201d \u201cintend,\u201d \u201ctarget,\u201d \u201cproject,\u201d \u201ccontemplates,\u201d \u201cbelieves,\u201d \u201cestimates,\u201d \u201cpredicts,\u201d \u201cpotential,\u201d \u201cupcoming\u201d or \u201ccontinue\u201d or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, data that we report may change following completion or a more comprehensive review of the data related to the clinical studies; we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics\u2019 business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects or inadequate efficacy of the Company\u2019s product candidates that may limit their development, regulatory approval and\/or commercialization; the Company\u2019s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics\u2019 clinical studies and nonclinical studies; regulatory developments<\/em>or political changes, including the policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics\u2019 drug candidates may not advance in development; Crinetics may use its capital resources sooner than expected<\/em>or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company\u2019s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company\u2019s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading \u201cRisk Factors\u201d in Crinetics\u2019 periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2024. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.<\/em><\/p>\nMedia:<\/strong>\r\nNatalie Badillo\r\nHead of Corporate Communications\r\nnbadillo@crinetics.com<\/a>\r\n(858) 345-6075\r\n\r\nInvestors:<\/strong>\r\nGayathri Diwakar\r\nHead of Investor Relations\r\ngdiwakar@crinetics.com<\/a>\r\n(858) 345-6340<\/pre>\n
AGENCIA EFE S.A.U.,S.M.E. shall not be liable for any information contained in this message and assumes no responsibility towards third parties in relation to its contents, being expressly exempt from any liability that the author may have in relation to the information in question. Agencia EFE reserves the right to distribute the press release on the news wire, or to publish it on EFE Comunica.<\/em><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"