The candidate drug – IPTN2021 is based on Initiator Pharma’s IPED2015 assets that already have proven safe and tolerable in clinical trials and have demonstrated efficacy for erectile dysfunction. The preclinical data package for IPED2015 also consists of substantial effects in animal pain models and provides the scientific rationale for expanding into the pain field. The intent is to start with a Proof-of-Principle Pain IPTN2021 trial in healthy volunteers with inflected pain and then follow up with a Phase 2 trial including Trigeminal Neuralgia patients.
Trigeminal Neuralgia is a deliberating orofacial pain condition characterized by sudden onset of an extreme, short-duration yet debilitating pain, often referred to as suicidal pain. There is only one FDA-approved pharmacological treatment for Trigeminal Neuralgia available, Carbamazepine. The treatment only provides limited pain relief and is associated with a significant number of side effects. Therefore, the unmet need for a new efficacious, tolerable and safe treatment is exceptionally high. It is Initiator Pharma's ambition to develop a First-Line treatment for these patients.
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....