Crinetics Pharmaceuticals, Inc. (CRNX) made a public announcement on Tuesday regarding the successful results of their Phase 3 PATHFNDR-2 trials. The trials were conducted to evaluate the efficacy and safety of paltusotine, a daily oral medication developed for the treatment of acromegaly.
The PATHFNDR-2 studies were randomized, double-blind, and placebo-controlled, lasting a total of 24 weeks. The study achieved statistical significance on the primary endpoint, signifying that paltusotine had a dramatic and measurable effect. According to Crinetics, all secondary endpoints, or additional goals of the study, also demonstrated statistical significance.
Feedback from the studies indicate that paltusotine was generally well-received with no serious side effects reported.
Acromegaly is an adult disorder triggered by a malfunctioning pituitary gland.
Looking forward, Crinetics plans to submit a New Drug Application for paltusotine to the U.S. Food and Drug Administration in the latter half of 2024.
