Tuesday, Crinetics Pharmaceuticals Inc CRNX released topline results from PATHFNDR-2, the second of two Phase 3 studies evaluating the efficacy and safety of paltusotine for acromegaly.
Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood.
The 111-participant 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.
In PATHFNDR-2, paltusotine was generally well-tolerated, and no serious adverse events were reported in participants who were treated with paltusotine.
The company plans to submit a New Drug Application to the FDA in the second half of 2024 and is preparing for a potential 2025 launch.
"Paltusotine continues to exceed expectations. Today, PATHFNDR-2 delivered statistically significant topline results across the board," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.
Last week, Crinetics Pharmaceuticals announced topline results from its open-label Phase 2 carcinoid syndrome study of paltusotine for acromegaly and carcinoid syndrome.
The data showed that paltusotine treatment demonstrated rapid and sustained reductions in the frequency and severity of flushing episodes and bowel movements.
Paltusotine was generally well-tolerated and showed an overall PK profile consistent with prior studies.
Price Action: CRNX shares are up 19.30% at $45.23 on the last check Tuesday.
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