Tuesday, Crinetics Pharmaceuticals Inc CRNX has published topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of paltusotin for acromegaly.
Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood.
The study, conducted in 111 participants, reached statistical significance (p<0.0001) on the primary endpoint, based on the percentage of participants taking paltusotin (56%) who achieved an insulin-like growth factor 1 level (IGF-1) ≤ 1.0 times the upper limit of normal level (xULN) compared to those taking placebo (5%).
All secondary endpoints also reached statistical significance.
In the PATHFNDR-2 study, paltusotin was generally well tolerated and no serious adverse events were reported in participants treated with paltusotin.
The company plans to submit a New Drug Application to the FDA in the second half of 2024 and is preparing for a potential launch in 2025.
“Paltusotin continues to exceed expectations. Today, PATHFNDR-2 delivered statistically significant first-line results across the board,” said Scott Struthers, Ph.D., founder and CEO of Crinetics.
Last week, Crinetics Pharmaceuticals announced topline results from its Phase 2 open-label carcinoid syndrome study with paltusotin for acromegaly and carcinoid syndrome.
The data showed that treatment with paltusotin demonstrated rapid and long-lasting reductions in the frequency and severity of hot flash episodes and bowel movements.
Paltusotin was generally well tolerated and showed an overall pharmacokinetic profile consistent with previous studies.
Price Action: CRNX shares were up 19.30% at $45.23 on Tuesday, at last check.