Second study success tees up FDA filing for Crinetics’ oral acromegaly drug
19 Mar 2024
Phase 3Clinical Result
Crinetics Pharmaceuticals’ experimental drug paltusotine hit the primary endpoint of a second Phase III study for the treatment of acromegaly, setting up an FDA marketing application in the second half of the year. CEO Scott Struthers said Tuesday that the oral SST2 agonist “delivered statistically significant top-line results across the board,” adding “our team is actively preparing for a potential 2025 launch.”
Results from the PATHFNDR-2 trial showed that 56% of participants on paltusotine achieved an insulin-like growth factor 1 (IGF-1) level ≤ 1 times the upper limit of normal compared to 5% on placebo. Crinetics added that all secondary endpoints also met statistical significance.
In September last year, the company reported that in the Phase III PATHFNDR-1 study, 83% of patients on paltusotine maintained an IGF-1 level ≤1 times the upper limit of normal, compared to 4% in the placebo arm, meeting its primary endpoint.
More to come.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.