Allodynic therapeutic is focused first on advancing ALLOD-2 for the treatment of migraine. The acute migraine indication is uniquely suited to potentially provide data to support the FDA’s combination rule for fix dose combination products. The Low Back Pain indication is also being investigated in a phase 2B study.
ALLOD-2 is a First-in-Class drug due to its new and unique mechanism of action. This non-narcotic product may provide a safer and more effective alternative to opioid painkillers.
In predisposed individuals, chronic low back pain and migraine occur due to an exuberant innate immune system activation (to the detriment of the host) nearby cranial or spinal nerve roots. The innate immune system activation leads to the release of proinflammatory cytokines [nitric oxide (NO), tumor necrosis factor-α (TNF-α), and reactive oxygen species (ROS)], and to activation of COX-2. The resulting neuroinflammation triggers pain along the anatomical distribution of the nerve roots. In the spine, exuberant innate immune system activation is triggered by nearby tissue injury, (e.g., intervertebral disc pathology, or degenerative abnormalities of the spine).
Back pain becomes chronic when the immune system becomes “stuck in a fighting mode.” ALLOD-2 reverses the neuro-inflammation through dual action, inhibition of the release of pro-inflammatory cytokines and inhibition of the COX-2 activation. High efficacy for treatment of CLBP and for treatment of migraine may suggest the product addresses the root cause of pain.
For more information, please visit clinicaltrials.gov