Nektar Therapeutics, a biopharm company with a pipeline of novel therapeutics based on its polymer conjugation technology platforms, today released positive interim data from an ongoing single-dose, phase I clinical trial to evaluate NKTR-181, the company’s mu-opioid analgesic candidate for pain management.
The phase I study assessed NKTR-181 in approximately 125 healthy subjects with the objective of establishing the effective analgesic dose range of NKTR-181 associated with minimal central nervous system (CNS) side effects.
Nektar reported that according to interim study result, the molecule achieved its study objectives with excellent safety and tolerability profile with no dose-limiting tolerability issues observed to-date.
By demonstrating slower entry into the CNS compared to historical oxycodone data, the company said that NKTR-181 has the potential to reduce the euphoria that is often associated with opioid abuse liability and dependence; it also has the potential to reduce the serious CNS-related side-effects of respiratory depression and sedation.
“NKTR-181 is an exciting development in pain management research,” Lynn R. Webster, MD, medical director of Lifetree Clinical Research stated in the press release. “New therapeutics to manage chronic pain without the serious risks associated with existing opioids are desperately needed. A novel opioid therapy, such as NKTR-181, with lower potential for abuse liability and fewer CNS-related side effects than existing opioids, provides great promise for pain practitioners looking for safer, more effective pain management. …”
Additional data from the study show that NKTR-181 demonstrates that while the treatment is rapidly absorbed, its centrally-mediated opioid effects appear slowly.
“NKTR-181 shows linear kinetics, dose proportionality and a half-life following oral administration that should allow once or twice daily dosing,” said Robert Medve, MD, vice president of Development and Clinical Head of the NKTR-181 Program at Nektar Therapeutics. “The results we’ve seen to date with NKTR-181 in the clinic add to our excitement over the potential of this novel analgesic candidate and the role it could play in treating chronic pain while addressing the risks associated with existing opioids.”
Dr. Medve said the phase I data supports continued rapid development of NKTR-181 and that the company will initiate the multi-dose phase I study in the second half of 2011.
For more information, visit www.nektar.com