TNX-1900
Preclinical
Phase I
Phase II
Phase III
Adolescent Obesity, Binge Eating Disorder, Bone Health in Autism, and Social Anxiety Disorder
Phase II Investigator-Initiated Studies
Phase II
TNX-1900 (intranasal potentiated oxytocin) is in Phase 2 development under investigator-initiated INDs at the Massachusetts General Hospital as a candidate for adolescent obesity, binge eating disorder, and bone health in autism, and at the University of Washington for social anxiety disorder. Tonix owns the rights to develop TNX-1900 for craniofacial pain and insulin resistance.
TNX-1900 is a drug-device combination product, based on an intranasal actuator device that delivers oxytocin into the nasal cavity. Tonix’s formulation is believed to increase specificity for oxytocin receptors relative to vasopressin receptors as well as to enhance the potency of oxytocin, a naturally occurring human hormone that acts as a neurotransmitter in the brain. Oxytocin has no recognized addiction potential.
Oxytocin, when delivered via the nasal route, concentrates in the trigeminal system1 resulting in binding of oxytocin to receptors on neurons in the trigeminal system. With TNX-1900, the addition of magnesium to the oxytocin formulation enhances oxytocin receptor binding2 as well as its inhibitory effects on trigeminal neurons and resultant craniofacial analgesic effects, as demonstrated in animal models3. Intranasal oxytocin has been shown to be well tolerated in several clinical trials in both adults and children4. Targeted nasal delivery results in low systemic exposure and lower risk of non-nervous system, off-target effects.
Sources
1Lawson EA, et al. J Neuroendocrinol 2020;32(4):e12805. doi: 10.1111/jne.12805.
2Antoni FA and Chadio SE. Biochem J. 1989. 257(2):611-4.
3Cai Q, et al., Psychiatry Clin Neurosci. 2018. 72(3):140-151.
4Yeomans, DC et al. 2017. US patent US2017368095.