Nektar Starts Phase3 SUMMIT-07 Study Of NKTR-181 In Patients With CLow Back Pain

(RTTNews) - Nektar Therapeutics (NKTR) announced the enrollment of the first patient in SUMMIT-07, its initial Phase 3 study of NKTR-181, a first-in-class, opioid analgesic molecule with a slow rate of entry into the brain. This slow rate of entry is designed to reduce the euphoria that can lead to the abuse of current opioid analgesics.

SUMMIT-07 will evaluate the efficacy, safety and tolerability of NKTR-181 in patients with chronic low back pain who are also opioid-naïve (new to treatment).

NKTR-181 is a new chemical entity (NCE) that was created using Nektar's proprietary small molecule polymer conjugate technology. NKTR-181 has several potential differentiating properties that are inherent to the structure of the molecule, including a slow rate of entry into the CNS as measured by pupillometry (contraction of the pupils) and a plasma pharmacokinetic profile that supports twice-daily oral dosing. NKTR-181 is not a reformulation of a marketed opioid, which is a commonly-used method to attempt to prevent the manipulation of existing long-acting opioid drugs into more abusable forms.

NKTR-181 has been granted has been granted Fast Track designation for the treatment of moderate to severe chronic pain by the U.S. Food and Drug Administration.