Second study success tees up FDA filing for Crinetics’ oral acromegaly drug

19 Mar 2024
Phase 3Clinical Result
Crinetics Pharmaceuticals’ experimental drug paltusotine hit the primary endpoint of a second Phase III study for the treatment of acromegaly, setting up an FDA marketing application in the second half of the year. CEO Scott Struthers said Tuesday that the oral SST2 agonist “delivered statistically significant top-line results across the board,” adding “our team is actively preparing for a potential 2025 launch.”
Results from the PATHFNDR-2 trial showed that 56% of participants on paltusotine achieved an insulin-like growth factor 1 (IGF-1) level ≤ 1 times the upper limit of normal compared to 5% on placebo. Crinetics added that all secondary endpoints also met statistical significance.
In September last year, the company reported that in the Phase III PATHFNDR-1 study, 83% of patients on paltusotine maintained an IGF-1 level ≤1 times the upper limit of normal, compared to 4% in the placebo arm, meeting its primary endpoint.
More to come.
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