Benzinga - by Vandana Singh, Benzinga Editor.
On Sunday, Crinetics Pharmaceuticals Inc (NASDAQ: CRNX) said its Phase 3 PATHFNDR-1 study evaluating paltusotine met the primary and secondary endpoints in acromegaly patients.
Acromegaly is a rare condition where the body produces too much growth hormone, causing body tissues and bones to grow more quickly. Over time, this leads to abnormally large hands and feet and many other symptoms.
Related: Biotech Stock Crinetics Pharmaceuticals Positioned For Success In Chronic Endocrine Disorder Treatment, Says Analyst.
The PATHFNDR-1 was a randomized, double-blind, placebo-controlled 36-week treatment period followed by an optional open-label extension study evaluating paltusotine in participants with acromegaly switching from standard-of-care injected depot somatostatin analogs.
The study enrolled participants with acromegaly who were biochemically controlled on octreotide or lanreotide depot monotherapy.
The study met statistical significance (p
Mean acromegaly symptom diary scores were maintained on paltusotine vs. an increase on placebo (p=0.02) after switching from injected depot standard of care.
Paltusotine was well tolerated, and no serious or severe adverse events were reported.
PATHFNDR-2, a Phase 3 study of oral paltusotine in participants with acromegaly who are treatment-naïve or not currently receiving medical therapy, is fully enrolled, and topline data are expected in Q1 of 2024. Crinetics plans to submit a new drug application to the FDA in 2024, seeking regulatory approval for all acromegaly patients who require pharmacotherapy, including newly diagnosed patients and those switching from other therapies.
The company is also conducting an open-label Phase 2 study to evaluate paltusotine in patients with carcinoid syndrome and intends to report preliminary results later this year.
Carcinoid syndrome is caused by a carcinoid tumor that secretes serotonin or other chemicals into your bloodstream.
Price Action: CRNX shares are up 67.40% at $26.74 on the last check Monday.
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