Crinetics’ Once-Daily Oral Paltusotine Achieved the Primary and All Secondary Endpoints in the Phase 3 PATHFNDR-2 Study in Acromegaly Patients
56% of Participants on Paltusotine Achieved IGF-1 ≤1.0 xULN vs. 5% on Placebo (p<0.0001)
Paltusotine was Generally Well-tolerated with No Serious Adverse Events
Positive Topline Results Support Planned NDA Submission to the FDA in 2H 2024
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SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, today announced positive topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of oral, once-daily investigational paltusotine for the treatment of acromegaly.
PATHFNDR-2 (NCT05192382) was a randomized, double-blind, placebo-controlled 24-week treatment period followed by an optional open-label extension study evaluating paltusotine in 111 participants with acromegaly who were not pharmacologically treated. The study met statistical significance (p<0.0001) on the primary endpoint, based on the proportion of participants taking paltusotine (56%) who achieved an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 times the upper limit of normal (xULN) compared to those taking placebo (5%). All secondary endpoints also met statistical significance:
Paltusotine (n=54) |
Placebo (n=57) |
p-value |
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Primary Endpoint: | |||||
Proportion of participants who achieved an IGF-1 level ≤ 1.0 xULN, % (n) |
56% (30/54) |
5% (3/57) |
<0.0001 |
||
Secondary Endpoints: | |||||
Change from baseline in IGF-1 level (xULN) | -0.82 | 0.09 | <0.0001 | ||
Proportion of participants who achieved IGF-1 level of <1.3 xULN at EoR* | 67% | 14% | <0.0001 | ||
Change from baseline in Acromegaly Symptoms Diary (ASD) total score | -2.67 | 2.75 | 0.004 | ||
Proportion of participants who achieved growth hormone (GH) level of <1.0ng/mL at EoR | 57% | 18% | <0.0001 | ||
*EoR: End of Randomized control phase |
“These positive topline results of PATHFNDR-2 are incredibly exciting for both patients with acromegaly and the healthcare providers who treat them,” stated 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 PATHFNDR program. “This study demonstrates that paltusotine can provide both symptom control as well as biochemical control in patients who are not currently on pharmacologic treatment. If approved, the prospect that paltusotine can offer an innovative, once-daily oral alternative represents a significant step forward in improving the treatment experience for patients.”