Concert Pharmaceuticals has achieved an $8 million milestone under its development and license agreement with Celgene Corporation for completion of the Phase 1 clinical evaluation of CTP-730. CTP-730 is a deuterium-modified analog of apremilast, a selective phosphodiesterase 4 (PDE4) inhibitor. Once-daily dosing of 50 mg of CTP-730 administered for 7 days in the Phase 1 trial demonstrated similar steady-state exposure to historical data for 30 mg of apremilast administered twice daily.
“We are encouraged by the favorable pharmacokinetic profile of CTP-730 observed in our Phase 1 clinical trials,” stated Roger Tung, Ph.D., President and Chief Executive Officer of Concert Pharmaceuticals. “We believe that selective incorporation of deuterium in apremilast has resulted in a potential next generation anti-inflammatory agent.”
The Phase 1 program included both single and multiple ascending dose trials. The Phase 1 clinical trials assessed the safety, tolerability and pharmacokinetics of CTP-730 in 85 healthy subjects. Treatment with CTP-730 was generally well tolerated and no serious adverse events were observed. The most common adverse events were similar to those already identified for apremilast.
The CTP-730 Phase 1 clinical trials were conducted under a 2013 development and license agreement established by Concert and Celgene to evaluate deuterium-modified compounds for inflammatory diseases and cancer. The collaboration is initially focused on the development of CTP-730, but has the potential to encompass up to three additional programs. Celgene is responsible for all development costs of CTP-730 beyond the Phase 1 clinical trials conducted by Concert.