Pharmaceutical Business Review – US-based biopharmaceutical firm Trigemina has expanded its Phase II clinical trial for TI-001, intranasal oxytocin, beyond Chile to include sites in Brisbane and Adelaide, Australia.
The Phase II TRIG-05 trial is assessing TI-001, an investigational, nasally-delivered oxytocin therapeutic currently being examined to determine its efficacy, tolerability, and safety in chronic migraine patients.
Secondary endpoints in the trial include determining the best Phase III dosage and exploring interlukin-6 (IL-6) levels as a potential biomarker for predicting efficacy.
About 96 patients are expected to be enrolled in the placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched TRIG-05 clinical trial.
If approved by the US Food and Drug Administration (FDA), TI-001 could be the first non-invasive treatment approved for chronic migraine.
Trigemina president and CEO Charles Yeomans said the expansion of the Phase II study to centers in Australia shows the increasing excitement and support throughout the international community in addressing one of the most urgent global needs in drug development: a safe and effective therapy for chronic migraine.
“This progress will place us on track to complete enrollment of the trial in the second half of 2014,” Yeomans said.
The company is mainly focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products.