Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 77

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 8
Chunk 77
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 activity in a dose-dependent manner in different mouse tumor growth models without a decrease in body weight.

•We provided additional details regarding the trial design of BRAVESST2, our Phase 1/2 study of CRN09682 for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors and other SST2-expressing solid tumors. In the Phase 1 dose escalation phase, we expect to enroll 3-6 patients per cohort until the minimum tolerated dose is confirmed. Data from the dose escalation will inform the recommended expansion dose for the Phase 2 dose expansion phase and confirm the tumor sub-types that will be enrolled in the expansion cohorts. 

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We expect to enroll up to 150 participants across both Phase 1 and Phase 2 of the trial.

•CRN12755: We provided preclinical data on our lead candidate, CRN12755, in the TSHR antagonist program for the treatment of Graves’ disease, including the two major manifestations Graves’ hyperthyroidism and Graves’ orbitopathy (Thyroid Eye Disease, or TED). CRN12755 was observed to decrease TSAb-stimulated thyroid hormone (T4) in a rat model, and was observed to decrease hyaluronic acid and IL-6 production in Graves Orbital Fibroblasts, or GOFs from TED patients. We also provided an overview of the clinical development strategy for CRN12755, including key biomarkers and other data to be captured in the Phase 1 trial. 

•CRN10329: We identified CRN10329 as a preclinical leading development candidate for a selective somatostatin receptor type 3 (SST3) nonpeptide agonist for the treatment of autosomal dominant polycystic kidney disease, or ADPKD. CRN10329 was observed to decrease cystic index, cellular proliferation, kidney weight and aberrant expression of renal tubular injury markers in a mouse model of ADPKD. We also shared data highlighting that SST3 is highly and consistently expressed in cyst-lining cells in ADPKD.

•Based on emerging data from IND enabling studies, focus of the TSHR antagonist program has shifted to bringing forward an alternative candidate with a superior profile. There is also follow-up preclinical work needed on the IND-enabling studies for the SST3 program that will postpone its IND submission. 

International Expansion:

•We continued international expansion activities in parallel with the ongoing review of our MAA for