Trigeminal neuralgia is a chronic pain condition that affects the trigeminal nerve. The trigeminal nerve carries sensation from the face to the brain. In patients with trigeminal neuralgia, even mild stimulation of the face, such as brushing your teeth or putting on makeup, may trigger a jolt of excruciating pain. The disease is seriously invalidating. It is reported that worldwide 150,000 people are diagnosed with trigeminal neuralgia (TN) every year. Trigeminal neuralgia affects women more often than men, and it's more likely to occur in people who are older than 50. The causes of the disease include pressure on the nerve, aging, brain disease or is idiopathic. The treatment involves medications and surgery. Clinical guidelines recommend carbamazepine (the only drug FDA-approved for TN) and oxcarbazepine as first-line therapies, however the current medication is often found ineffective and with serious adverse events(1). Therefore there is an unmet need, which Initiator will address in the IPTN2021 program.
In the IPTN2021 program the Active Pharmaceutical ingredient is (API) IP2015. Monoamines play an important role in regulating the endogenous pain system, particularly in neuropathic pain. Monoamine transporters are validated drug targets e,g, Duloxetine (primarily SERT and NET modulation) has proven efficacious in some pain indication, but the drug has significant side effects e.g: sexual problems, liver tox. Whereas, the data generated for IP2015 drug candidate demonstrate a clear improvement on safety and tolerability.
In preclinical studies, IPED2015 is effective and markedly inhibits neuralgic pain. We aim in a Proof-of- Principle study to examine the effect of IPED2015 in subjects exposed to the sensory nerve stimulant capsaicin. The protocol is under development and conducted in collaboration with the MAC clinic, Manchester, UK.
(1) Joanna M. Zakrzewska, Eastman Dental Hospital, London, United Kingdom Mark E. Linskey, University of California Irvine, Irvine, California Am Fam Physician. 2016 Jul 15;94(2):133-135.