TorreyPines Therapeutics, Inc. completes phase I clinical trial for tezampanel (NGX424), a first-in-class compound in development for the treatment of acute migraine, and plans to move forward with a phase II clinical trial during the second half of this year.
An AMPA/kainate (AK) receptor antagonist, tezampanel offers a non-opioid, non-vascular approach to the management of migraine and other persistent pain states and represents a promising alternative to current treatments.
"We are pleased with the results of our phase I study and we look forward to initiating a phase II program evaluating subcutaneous administration of tezampanel in the treatment of acute migraine," said Neil Kurtz, president and CEO of TorreyPines. "With its previously established efficacy when given intravenously, this compound has the potential to offer migraine sufferers the first novel alternative to their pain management in more than a decade," he added.
According to the release, the company also plans to file an Investigational New Drug Application with the US FDA this year for its follow-on compound NGX426, an oral prodrug of tezampanel. Both compounds may effectively relieve severe and persistent pain through a novel mechanism that does not impart the side effects and risks associated with currently available migraine and other pain treatments.
"With these compounds, TorreyPines looks forward to meeting the growing and unmet need for non-narcotic pain management that is highly effective and without significant side effects," Dr. Kurtz said adding, "The company intends to continue development of the intravenous route of administration, as well as to develop intrathecal and epidural formulations. These multiple dosing routes permit development across a range of indications including migraine, epilepsy, neuropathic pain, spinal cord injury and other intractable pain states."