Nektar Therapeutics (NASDAQ: NKTR) has announced positive results from an early study on the effectiveness of a new short-acting opioid drug candidate. The company said the drug – called NKTR-192 – achieved its target pharmacokinetic profile during a Phase 1a clinical study. Dosing of NKTR-192 has also begun in a second Phase 1a study, according to Nektar.
NKTR-192 is designed for the treatment of moderate to severe acute pain. Nektar uses polymer conjugation technology to slow the drug’s entry into the central nervous system (CNS). Slowing the rate of entry into the brain reduces the “high” that some patients get from opioids, and lowers the risk of abuse and addiction.
“With NKTR-192, we set out to build a new molecule that behaves differently than other opioids, preserving the powerful pain relief but changing the way it enters the brain and how it targets receptors throughout the body,” said , MD, Chief Medical Officer of Nektar Therapeutics. “The way we have engineered NKTR-192 may allow us to reduce the euphoria, or rush, that can drive opioid abuse and dependence, while at the same time reducing other unwanted CNS side effects, such as sedation. These potential unique characteristics of NKTR-192 are built into the molecular design. This is designed to be different.”
The second Phase 1a clinical study will assess the pharmacodynamic profile and tolerability of NKTR-192 in up to 48 healthy subjects. The Phase 1 study is being conducted at Lifetree Clinical Research in Salt Lake City, Utah.
“Results from our first clinical study of NKTR-192 demonstrated that this new mu-opioid molecule achieved a short-acting pharmacokinetic profile which is ideal for the treatment of acute pain,” said Medve.
In preclinical studies, the company says NKTR-192 demonstrated a reduced rate of entry into the central nervous system, demonstrating the potential to greatly reduce the euphoria that underlies abuse, dependence and other side effects, such as sedation.
Nektar has a pipeline of novel opioid painkillers in clinical study, including NKTR-181, which has been designated for “fast track” development by the Food and Drug Administration for the treatment of moderate to severe chronic pain. Like NKTR-192, NKTR-181 is designed to enter the brain slowly, at a rate about ten times slower than oxycodone and other opioids.
Since the end of 2011, Nektar’s stock has risen nearly 60%, from $5.60 a share to over $9 a share.