ISP of Chile approves Trigemina's protocol for Phase 2 clinical study of TI-001

Apr 9 2013

Trigemina, Inc., a biopharmaceutical company focused on the discovery and development of non-narcotic, nasally delivered, analgesic drug products, today announced that the Instituto de Salud Publica (ISP) of Chile has approved the Company's protocol for its Phase 2 clinical study of TI-001, intranasal oxytocin, for the treatment of chronic migraine. The TRIG-05 study is expected to begin enrollment in April, 2013, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety of TI-001.

"The ISP acceptance of our study protocol is an important step forward for the clinical development of TI-001 in chronic migraine patients," said Charles Yeomans , Chief Executive Officer of Trigemina. "TI-001 demonstrated strong efficacy in our preclinical and pilot human studies, especially for such a difficult to treat condition as chronic migraine. With approval from the ISP of Chile, we are confident that we will be able to move forward with our business development goals for 2013 as planned."

In preclinical and human pilot studies, treatment with TI-001 has shown promising results for use as a safe and effective therapy for all forms of chronic and subacute head pain. In one study, 64% of chronic migraine patients receiving TI-001 improved from severe to mild/no pain or from moderate to no pain, whereas only 28% of patients receiving placebo reported improvement. Importantly, 29% of patients receiving TI-001 improved to zero pain, compared to none of the placebo treated patients, suggesting strong efficacy for the therapy with little to no side effects and no risk of developing addiction.

"The unique science underlying TI-001's robust efficacy and lack of abuse potential is the relationship shared between pain and oxytocin," stated David C. Yeomans , Ph.D., Chief Scientist and Founder of Trigemina and Director of Pain Research at Stanford University School of Medicine. "Prolonged pain increases the amount of oxytocin receptors for the drug to work on. Because of this, those with chronic migraines are in an almost constant state of elevated oxytocin receptor numbers on trigeminal neurons. With nasal delivery, TI-001 directly applies oxytocin to the trigeminal neurons and rapidly produces an analgesic effect, but only in the presence of painful inflammation."

The TRIG-05 Phase 2 study is a placebo-controlled, double-blind, randomized-withdrawal and enrollment enriched trial of TI-001 in chronic migraine patients. A total of 96 patients will be enrolled in four trial sites in Chile and another trial site in Argentina to begin in June. The study's primary objective is demonstrating efficacy, tolerability and safety. Additional objectives will include determining the appropriate dose for a future Phase 3 trial and to explore baseline IL-6 plasma levels as a potential biomarker for efficacy response.