The proprietary clinical program IPTN2021 is targeting an orphan drug indication in severe neuropathic pain, trigeminal neuralgia. IPTN2021 is based on Initiator’s IP2015 API that already have proven safe and tolerable in clinical trials and have demonstrated efficacy for erectile dysfunction. In preclinical studies, IP2015 is effective and markedly inhibits neuralgic pain.
A developmental benefit of trigeminal neuralgia is the opportunity to apply for Orphan Drug Designation and subsequent Fast Track designation or conditional approval by the FDA or EMA, respectively. The interaction with the regulatory authorities will provide valuable guidance for both the design of the first IPTN2021 trial in patients and for a potential subsequent registration trial.
Initiator aim in a Proof-of-Principle study to examine the effect of IP2015 in subjects exposed to the sensory nerve stimulant capsaicin. The protocol is under development and conducted in collaboration with the MAC clinic, Manchester, UK. If successful results, the Proof-of-Principal study will be followed by a Phase 2 trial including trigeminal neuralgia patients.