Crinetics’ Paltusotine Demonstrates Success in Second Phase III Trial for Oral Acromegaly Treatment, Prepares for FDA Filing

1. Crinetics Pharmaceuticals achieved a second successful Phase III trial for its oral, once-daily investigational drug called paltusotine, designed to treat acromegaly, a rare hormonal disorder.
2. In the PATHFNDR-2 study, 56% of patients on paltusotine achieved the primary endpoint of reduced insulin-like growth factor 1 (IGF-1) levels compared to 5% on placebo, with no serious adverse events reported.
3. This follows a previous positive Phase III trial where 83% of treated patients maintained IGF-1 levels within the upper limit of normal when switching from injections to paltusotine.
4. With these promising results, Crinetics plans to submit a New Drug Application (NDA) to the FDA during the second half of the year, aiming for a possible 2025 launch.
5. Analysts estimate a market opportunity of approximately $300 million for paltusotine if approved.
6. Paltusotine is also being tested in carcinoid syndrome, with positive Phase II topline results announced recently.
7. The PATHFNDR-2 trial included 111 acromegaly patients with elevated IGF-1 levels, some of whom were medication naïve or had previously stopped treatment.