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Crinetics' hormonal disorder drug succeeds in late-stage study
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Crinetics' hormonal disorder drug succeeds in late-stage study
Mar 19, 2024 5:26 AM

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.

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