Crinetics Pharmaceuticals Inc. (NASDAQ: CRNX) recently announced the topline results from PATHFNDR-2, the second Phase 3 study evaluating the efficacy and safety of paltusotine for acromegaly. Acromegaly is a hormonal disorder that occurs when the pituitary gland produces too much growth hormone during adulthood.
The study, which involved 111 participants, achieved statistical significance on the primary endpoint, with 56% of participants taking paltusotine achieving an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 times the upper limit of normal (xULN) compared to 5% of those taking a placebo. Additionally, all secondary endpoints also met statistical significance.
Paltusotine was well-tolerated in the study, with no serious adverse events reported in participants treated with the drug. The company plans to submit a New Drug Application to the FDA in the second half of 2024, with a potential launch in 2025.
Scott Struthers, Ph.D., founder and CEO of Crinetics, expressed his excitement about the results, stating that paltusotine continues to exceed expectations.
In addition to the PATHFNDR-2 results, Crinetics Pharmaceuticals also recently announced topline results from an open-label Phase 2 study of paltusotine for acromegaly and carcinoid syndrome. The data showed rapid and sustained reductions in flushing episodes and bowel movements, with the treatment being well-tolerated and consistent with prior studies.
As a result of these positive results, CRNX shares were up 19.30% at $45.23 on the last check Tuesday.
Overall, the results from both studies highlight the potential of paltusotine as a promising treatment option for acromegaly and other related conditions. Crinetics Pharmaceuticals is on track to potentially bring this innovative therapy to market in the near future, offering hope to patients suffering from these challenging disorders.
