March 19 (Reuters) - Crinetics Pharmaceuticals ( CRNX )
said on Tuesday its experimental drug to treat a rare hormonal
disorder met the main goal of the second of two late-stage
studies, putting the company on track to seek U.S. approval
later this year.
Shares of the San Diego, California-based drug developer
jumped 8.2% in premarket trading. The stock has risen 45.4%
since September, when the same drug met the main goal of another
late-stage study.
The daily oral drug, called paltusotine, is being tested in
patients with acromegaly, a rare disease caused by benign tumors
that lead to high levels of the growth hormone. Excess levels of
the hormone can cause severe complications.
Acromegaly, which Crinetics estimates affects about 25,000
patients in the United States, is usually treated by surgically
removing the benign tumors.
Other options to treat the disease include injections such
as octreotide or lanreotide for patients whose surgery was
unsuccessful.
The study enrolled 111 adults with acromegaly who had
elevated levels of IGF-1 protein and were previously untreated.
In the study, 56% of 54 patients given paltusotine were able
to maintain standard levels of the protein that plays a role in
moderating the growth hormone, versus 5% of 57 patients on a
placebo.
The drug also helped to reduce symptoms of the disease, as
self reported by patients versus a placebo, which was one of the
secondary endpoints of the trial.
Crinetics said it plans to submit a marketing application
for the drug in the second half of 2024 and is preparing for a
potential launch in 2025.