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New Data Demonstrating Stable Biochemical and Symptom Levels with Two-Years of Oral Paltusotine Administration Presented at ENDO 2023

Early-Stage Candidates for Primary Hyperparathyroidism and Thyroid Eye Disease Also Featured

Crinetics' Founder & CEO, Scott Struthers Accepted John D. Baxter Prize for Entrepreneurship from ENDO President

SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) presented efficacy, safety and patient-reported outcome (PRO) data at ENDO 2023 for paltusotine, an experimental, once-daily, oral, small molecule somatostatin receptor type 2 (SST2) agonist in Phase 3 clinical development for the treatment of acromegaly. The Endocrine Society’s annual meeting, ENDO 2023, was held June 15-18, 2023, in Chicago, Illinois.

Dr. Monica R. Gadelha, M.D., Ph.D., 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 presented results from a planned two-year analysis of the company’s ongoing ACROBAT Advance open-label extension study at a podium presentation at ENDO 2023. Results demonstrated that patients switching from therapy with injected somatostatin receptor ligands (SRLs) to oral paltusotine maintained stable levels of key measures associated with acromegaly including insulin-like growth factor 1, growth hormone, acromegaly symptom diary (ASD) score, blood pressure, hemoglobin A1c, ring size, and body weight.

The ASD score was a composite representing participants’ daily impressions of common acromegaly symptoms including headache, joint pain, sweating, fatigue, weakness, swelling, and numbness/tingling.  

Approximately 90% of participants said they preferred once-daily, oral paltusotine over current standard of care of injected SRLs when asked after one year of treatment. Paltusotine was well tolerated, with a safety profile similar to injected SRLs. Two Phase 3 studies for paltusotine in acromegaly are currently ongoing.

“Paltusotine’s ability to maintain stable levels across multiple measures on a long-term basis as compared to baseline values achieved on prior therapy while also displaying a favorable safety profile in a broad range of acromegaly patients is promising and indicates that, if approved, it may represent a potential long-term oral alternative to the injected standard-of-care,” stated Dr. Gadelha.

Crinetics also presented preclinical proof-of-concept data on a parathyroid hormone receptor type 1 (PTH1R) antagonist, which is initially intended for the treatment of primary hyperparathyroidism (PHPT), which leads to hypercalcemia and bone loss if untreated. PHPT affects approximately 100,000 people annually in the U.S. Additional indications that may be addressed by a PTH1R antagonist include humoral hypercalcemia of malignancy (HHM), which is estimated to occur in as many as 200,000 cancer patients annually. The data presented in a poster at ENDO on June 17th show Crinetics’ PTH1R antagonist suppressing PTH-stimulated increases in ionized calcium, urinary cAMP, and bone resorption biomarkers in rats.

In addition, a thyroid-stimulating hormone (TSH) receptor antagonist for the treatment of thyroid eye disease (orbitopathy) associated with Graves’ disease was unveiled in a poster presentation. Graves’ is an autoimmune disease characterized by chronic overstimulation of the TSH receptor, which results in hyperthyroidism. In approximately 30% of patients, it also results in thyroid eye disease (TED) due to overactivation of the TSH receptor in orbital fibroblasts. Crinetics described preclinical proof-of-concept results from a pharmacologic rat model of Graves’ disease. These results showed an oral small molecule TSHR antagonist suppressing production of a key thyroid hormone, thyroxine (T4), which is over expressed in Graves’ disease and can lead to the pain, swelling, blurry vision, and proptosis associated with TED.

“Both PHPT and Graves’ disease are examples of endocrine disorders with well understood endocrinology but in need of better therapeutic options,” added Stephen Betz, Ph.D., Crinetics’ chief scientific officer. “These are exactly the types of endocrine diseases that we aim to address with our oral small molecule drug discovery programs.”

On June 15, 2023, the Endocrine Society’s president, Ursula B. Kaiser, M.D. presented Scott Struthers, Ph.D., Crinetics’ founder and CEO with the Society’s John D. Baxter Prize, an award for recognition of Entrepreneurship in Endocrinology. The Baxter Prize was established in memory of Endocrine Society Past President John D. Baxter, M.D., a world-renowned scientist best known for being the first to clone the human growth hormone gene and starting several biotech companies. During the award session, Dr. Struthers presented a lecture titled, “Adventures Discovering Nonpeptide Oral Drugs Acting at Peptide Hormone Receptors,” highlighting the complex and difficult process of discovering small molecules that target peptide hormone receptors. In addition, he reviewed the history of building Crinetics from bootstrapping with NIH-SBIR grants to the publicly traded company it is today with more than 250 full time staff and operations around the globe.

“At Crinetics, our discovery scientists strive to optimize every atom in each drug candidate to craft the best possible medicine we can for patients with endocrine diseases,” said Dr. Struthers. “These efforts yielded paltusotine, which entered into its first clinical studies in 2017. Since then, the Crinetics team has developed a rich pipeline of additional small molecule drug candidates hoping to improve treatment options for patients with endocrine disorders. I am grateful that the Baxter family and the Endocrine Society has established this prize to bring attention to the role that entrepreneurship can play in bringing all members of our community together to improve patient care and am honored and humbled to have been this year’s recipient.”

Copies of the ENDO 2023 presentation slides and posters are available here.

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, an investigational, oral 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 CRN04894, an investigational, oral ACTH antagonist in development for the treatment of Cushing’s disease and congenital adrenal hyperplasia and for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist in development for congenital hyperinsulinism. All of the company’s drug candidates are orally delivered, small molecule new chemical entities resulting from in-house drug discovery efforts.  

Forward-Looking Statements
This 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 plans for the clinical development of paltusotine, CRN04777 and CRN04894 or drug candidates for PHPT or TED, including the therapeutic potential and clinical benefits thereof. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” 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, topline data that we report may change following a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; 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; the COVID-19 pandemic and other geopolitical events may disrupt Crinetics’ 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’s product candidates that may limit their development, regulatory approval and/or commercialization; the company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments 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’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the company’s periodic filings with the SEC. The events and circumstances reflected in the company’s 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 “Risk Factors” in Crinetics’ periodic reports, including its annual report on Form 10-K for the year ended December 31, 2022. 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.

Chas Schultz 
VP, IR & Corporate Communications 
(858) 450-6464 

Investors / Media: 
Corey Davis 
LifeSci Advisors, LLC 
(212) 915-2577 

Aline Sherwood 
Scienta Communications 
(312) 238-8957  

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