On January 09, 2023 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, will provide a company update at the 41st Annual J.P. Morgan Healthcare Conference, which is taking place in San Francisco, CA from January 9-12, 2023 (Press release, Crinetics Pharmaceuticals, JAN 9, 2023, https://crinetics.com/crinetics-pharmaceuticals-to-present-corporate-and-clinical-update-at-41st-annual-j-p-morgan-healthcare-conference/ [SID1234626047]).
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Dr. Struthers’ presentation will take place on Wednesday, January 11th at 3:00 p.m. Pacific Time. A live webcast of the presentation may be accessed on the Events page of the company’s website. A replay of the webcast will be accessible at the same location.
The presentation will feature an overview of Crinetics’ key priorities and anticipated milestones for 2023. These include:
The continued advancement of the Phase 3 PATHFNDR-1 and PATHFNDR-2 trials of once-daily oral paltusotine in acromegaly. The trials remain on track for topline data readouts in the third and fourth quarters of 2023, respectively. If successful, Crinetics plans to submit data from the two studies to regulatory authorities in support of applications seeking approval for the use of paltusotine for all acromegaly patients who require pharmacotherapy, including untreated patients and those switching from other therapies.
Efforts to further increase commercial readiness so that the company can rapidly provide acromegaly patients with access to once-daily oral paltusotine, if approved.
The continued advancement of the Phase 2 trial of paltusotine in carcinoid syndrome, which remains on track for topline data in the second half of 2023.
Following proof-of-concept Phase 1 results for CRN04894, an investigational adrenocorticotropic hormone (ACTH) antagonist, initiating clinical trials in ACTH-dependent Cushing’s syndrome and congenital adrenal hyperplasia. Both studies are expected to begin in the first quarter of 2023.
Building off proof-of-concept Phase 1 results for CRN04777, an investigational, oral somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism.
The continued preclinical evaluation of investigational, oral small molecule parathyroid hormone receptor antagonists to identify a candidate for advancement into clinical trials. Initial target indications for this program may include primary hyperparathyroidism and hypercalcemia of malignancy, with potential opportunities in chronic kidney disease also being evaluated.
Leveraging the company’s leading G-protein-coupled receptor (GPCR) drug discovery platform to generate and develop additional small molecule drug candidates with the potential to address unmet needs in indications such as polycystic kidney disease, Graves’ Disease (including thyroid eye disease) and metabolic diseases (including diabetes and obesity).
"Crinetics is entering 2023 with strong momentum and potentially transformative milestones expected over the next year," said Dr. Struthers. "If successful, upcoming readouts from our Phase 3 PATHFNDR trials will support regulatory filings seeking paltusotine’s approval in acromegaly, while significantly de-risking its development in carcinoid syndrome. As in acromegaly, many patients with carcinoid syndrome are not well served by burdensome SST2 agonist injections and therefore may benefit from oral paltusotine. We are currently evaluating this hypothesis in a Phase 2 trial that we expect to provide proof-of-concept data later this year."
"Looking broadly, we believe successful readouts from our acromegaly and carcinoid syndrome trials could validate our endocrine driven strategy that is also being applied to CRN04894, CRN04777, and each of our other programs," continued Dr. Struthers. "Paltusotine is only the first of what we hope will be many future products that will come from the remarkable discovery and development engine that we have built. We are now beginning to lay the foundations for a commercial capability serving the same global community of endocrinologists that are helping us evaluate our drug candidates in their clinics. This coming year will be a critical step towards our long-term goal of building the premier fully integrated endocrine company that can sustainably innovate pioneering therapies for our patients around the world."