Crinetics Pharmaceuticals, Inc. (NASDAQ:CRNX) said on September 10, 2023, its lead drug paltusotine, a once-a-day oral treatment for the rare disease acromegaly, met the primary and secondary endpoints in a phase III trial named PATHFNDR-1.
Crinetics’ stock soared 63% to close at $26.08 per share on Monday. When SanaCurrents issued a report on August 5 forecasting positive data for the PATHFNDR-1 trial, the stock traded at $18.70 per share.
Acromegaly develops when the pituitary gland produces too much growth hormone during adulthood. Because of the disproportionate presence of growth hormone, certain bones become larger, resulting in outsized hands, face and feet in adults. Diagnosis is difficult as the change in features comes about over years.
The standard of care treatment is either monthly or daily injections of Somatostatin receptors ligand (SRL) drugs, or a rigid, twice-a-day oral regimen. The data from PATHFNDER-1 supported the daily dose of oral paltusotine. On the primary endpoint of maintaining an insulin-like growth factor 1 (IGF-1) level ≤ 1.0 times the upper limit of normal (xULN), 83% of subjects taking paltusotine achieved the endpoint compared to just 4% on placebo (p<0.0001).
One analyst described the PATHFNDER-1 as “picture perfect,” asserting paltusotine could emerge as the preferred therapy for acromegaly.
Crinetics expects to release data from PATHFNDER-2, a second phase III trial for paltusotine that addresses a larger patient population, in early 2024.