Crinetics Hosting Key Opinion Leader Meeting Focusing on Oral Paltusotine for the Treatment of Acromegaly


Webinar Being Held on Friday, November 20th, 11:00 am Eastern Time

SAN DIEGO, November 13, 2020 — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced that it will host a virtual Key Opinion Leader (KOL) meeting on oral paltusotine for the treatment of acromegaly on Friday, November 20, 2020 at 11:00 am Eastern Time.

The call will feature a presentation by KOLs Peter Trainer, MD (The Christie NHS Foundation Trust) and Monica Roberto Gadelha, MD, PhD (Medical School of the Universidade Federal do Rio de Janeiro), who will discuss the current treatment landscape, which is comprised primarily of injected somatostatin receptor ligand (SRL) products. In addition, they will share their insights into the unmet medical need in treating patients with acromegaly and the implications of the topline results from the Phase 2 ACROBAT studies with oral paltusotine that were released on October 26, 2020. Drs. Trainer and Gadelha will be available to answer questions following their formal presentations.

Crinetics’ management team will provide a brief update on oral paltusotine and two other pipeline assets that Crinetics expects will begin Phase 1 in the coming months. Paltusotine establishes a new class of oral selective nonpeptide somatostatin receptor type 2 (SST2) agonists designed for the treatment of acromegaly. Based on the positive topline Phase 2 results, Crinetics expects to begin its Phase 3 program in the first half of 2021, to further characterize the differentiating features relative to the current standard of care.

To register for the webinar, please click here.

Dr. Trainer is an active leader in the international endocrine community and has served on the senior executive committees of the Society for Endocrinology, the Endocrine Society and the European Society of Endocrinology (ESE). He chaired the ESE’s Programme Organising Committee in 2011 for the European Congress of Endocrinology and received the Society’s ‘Special Recognition Award’ in 2014 for his contributions as chairman of the Society’s Education Committee. He chaired the board of directors of Bioscientifica Ltd from 2014 to 2016 and served on the editorial board of Endocrine Connections, a Bioscientifica publication. His prime areas of interest are diseases of the pituitary and adrenal glands, particularly Cushing’s syndrome and acromegaly. His research has resulted in over 200 peer-reviewed publications. Dr. Trainer received his medical degree at the University of Edinburgh, undertook his general medical rotation at St. Bartholomew’s Hospital in London. In addition, he completed a European Economic Community exchange program as a resident at the Academisch Ziekenhuis Utrecht in the Netherlands and studied at Oregon Health & Sciences University in Portland, Oregon under a Fulbright scholarship.

Dr. Gadelha, a member of the Brazilian National Academy of Medicine, is a professor of endocrinology at the Medical School of the Universidade Federal do Rio de Janeiro (UFRJ) and directs the Neuroendocrine Research Center at UFRJ’s Hospital Universitário Clementino Fraga Filho (HUCFF), a premier research and teaching hospital in Brazil. Dr. Gadelha also heads the Neuroendocrine Section and the Molecular Genetics Laboratory of the Instituto Estadual do Cérebro Paulo Niemeyer. She is a board member in the Department of Neuroendocrinology at the Brazilian Society of Endocrinology and Metabolism, as well as a researcher at Brazil’s Conselho Nacional de Desenvolvimento Cientifico e Tecnológico and is president-elect of the Pituitary Society. Her main areas of interest are diseases of the pituitary gland, particularly acromegaly and Cushing’s disease. Dr. Gadelha’s clinical and translational research has resulted in over 150 peer-reviewed publications. She earned her medical degree from HUCFF-UFRJ and completed her doctoral research at the University of Illinois at Chicago, after which she returned to Brazil and received her PhD from UFRJ.

About Paltusotine

Paltusotine (formerly CRN00808) is an orally available nonpeptide biased agonist that is designed to be highly selective for the somatostatin receptor type 2. It was designed by the Crinetics discovery team to provide a once-daily oral option for patients with acromegaly and neuroendocrine tumors who are currently treated by injected therapies that sell approximately $3.1 billion annually. Topline results from Crinetics’ ACROBAT Edge and Evolve Phase 2 trials showed maintenance of insulin-like growth factor-1 (IGF-1) levels in acromegaly patients who were switched from first-line injected somatostatin receptor ligand (SRL) depots of either octreotide or lanreotide monotherapy. Paltusotine was observed to be well-tolerated among the 60 participants in the ACROBAT Edge and Evolve studies. Crinetics’ previously completed Phase 1 studies showed that paltusotine was 70% orally bioavailable and possesses a plasma half-life of ~2 days, supporting the potential for once-daily oral administration.

About Acromegaly

Acromegaly is a serious disease generally caused by a benign growth hormone (GH) secreting tumor in the pituitary. Excess GH secretion causes excess secretion of IGF-1 from the liver, which causes bone and cartilage overgrowth, organ enlargement, and changes in glucose and lipid metabolism. The symptoms of acromegaly include abnormal growth of hands and feet and changes in shape of the bone and cartilage that result in alteration of facial features. Overgrowth of bone and cartilage and thickening of tissue leads to arthritis, carpal tunnel syndrome, joint aches, enlarged lips, nose and tongue, deepening of voice due to enlarged vocal cords, sleep apnea due to obstruction of airways and enlargement of heart, liver and other organs.

Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients who 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 SRLs are usually the initial pharmacologic treatment, however these drugs require monthly injections and are commonly associated with pain, injection site reactions, and increased burden in the lives of patients. Although over 90% of patients have demonstrable responses to SRLs (Annals of Internal Medicine. 1992; 117:711-718) only 20-40% of patients achieve normalization of IGF-1 (J Clin Endocrinol Metab 99: 791–799, 2014). Additional pharmacological treatment options include dopamine agonists or GH receptor antagonists, which may be used in combination with SRLs.

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. The company’s lead product candidate, paltusotine (formerly CRN00808), is an oral selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 25,000 people in the United States. Crinetics plans to advance paltusotine into a Phase 3 program in acromegaly and a Phase 2 trial for the treatment of carcinoid syndrome associated with NETs in 2021. The company is also developing CRN04777, an oral nonpeptide somatostatin receptor type 5 (SST5) agonist for hyperinsulinism, as well as an oral nonpeptide 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 new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. For more information, please visit www.crinetics.com.

Forward-Looking Statements

Crinetics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential benefits of paltusotine for acromegaly patients; the potential to initiate a Phase 3 program of paltusotine in acromegaly based on the Edge and Evolve topline results and the timing thereof; and the planned expansion of the paltusotine development program to include the treatment of carcinoid syndrome in patients with NETs and the expected timing thereof, including initiation of a Phase 2 trial in these patients. The inclusion of forward-looking statements should not be regarded as a representation by Crinetics that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Crinetics’ business, including, without limitation: topline data that Crinetics reports is based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trials and such topline data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with Crinetics’ interpretation of such results; advancement of paltusotine into a Phase 3 program is dependent on and subject to the receipt of further feedback from the FDA; the COVID-19 pandemic may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the success of Crinetics’ clinical trials and nonclinical studies for paltusotine and its other product candidates; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of the company’s product candidates that may limit their development, regulatory approval and/or commercialization; Crinetics may use its capital resources sooner than it expects; and other risks described under the heading “Risk Factors” in documents 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 undertakes no obligation to update such statements to reflect events that occur or circumstances that 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.


Contact:
Marc Wilson
Chief Financial Officer
IR@crinetics.com
(858) 450-6464

Investors / Media:
Corey Davis
Life Science Advisors
cdavis@lifesciadvisors.com
(212)-915-2577

Aline Sherwood
Scienta Communications
asherwood@scientapr.com
(858) 450-6464

Source: Crinetics Pharmaceuticals, Inc.