The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) paltusotine orphan drug designation for the treatment of acromegaly, a disease usually caused by a benign growth hormone-secreting tumor in the brain’s pituitary gland.
Paltusotine, a new class of oral selective non-peptide somatostatin receptor 2 agonist, is currently being evaluated in a Phase 2 clinical trial. The company expects to report topline data from this trial in the fourth quarter of 2020, followed by initiation of a Phase 3 trial in the first half of 2021.
“The orphan drug designation by the FDA for paltusotine to treat acromegaly validates the encouraging clinical data we have seen so far in the Phase 2 ACROBAT Edge clinical trial, and underscores the need for a once daily oral treatment option for patients suffering from this rare disease,” Michael Monahan, Crinetics’ senior director of regulatory affairs, said in a statement.
