TI-001 for High Frequency Migraine
Trigemina is currently in Phase 2 clinical trials for TI-001, an intranasally administered formulation that includes oxytocin and other ingredients. Discovered in 1906, oxytocin, a natural hormone produced by the body, has been used to safely induce labor and lactation in pregnant and nursing women for more than 60 years with an excellent safety profile.
Trigemina has discovered that TI-001 passes through the nasal mucosa to the trigeminal nerve where its uptake can provide both an analgesic effect and reduce the frequency of migraines in those who are categorized by neurologists as chronic and high frequency episodic migraineurs.
TI-001 is currently being evaluated in a Phase 2 clinical study for efficacy, tolerability and safety in patients with chronic and high frequency episodic migraine. This study, designated NCT01839149 in clinicaltrials.gov, was initiated in mid 2013 and is being conducted in Chile, Australia and New Zealand in complete accordance with ICH guidelines. If approved by the U.S. Food and Drug Administration, TI-001 could be the first non-invasive treatment approved for both chronic and high frequency episodic migraine.
In open label data from its current trial, TI-001 has provided significantly superior relief to patients compared to any approved therapy with a high level of safety. Headache day reductions seen so far outpace that other therapies studied, and the frequency of secondary symptoms and the use of rescue medications for acute pain are also both significantly reduced.
Trigemina has been granted five patents issued by the U.S. Patent and Trademark Office in connection with the design and development of TI-001, and has issued patents in various countries around the world. Trigemina has two additional patents pending in the U.S. involving its discoveries related to TI-001.
TI-002 for Somatic Pain
Trigemina is currently in preclinical development on a highly promising, strong opioid replacement for whole body pain. TI-002 is an intranasal polypeptide that works by engaging the body’s own ability to inhibit pain, producing opiate-level analgesia without the adverse effects of opiates. In animal testing, the analgesic effect of TI-002 is comparable to morphine, but unlike morphine, there is no “high”, somnolence, abuse potential, tolerance concerns or constipation.
TI-002 is a promising drug candidate and could have significant implications as a novel therapy for a full body analgesic. Trigemina is continuing to perform preclinical work on this therapy, and is formulating plans to study TI-002 in human clinical studies. Trigemina has issued and pending worldwide patent coverage for TI-002.