Initiator Pharma A/S, a clinical-stage pharma company, announced today that all planned subjects have had the last visit in Clinical part in the IPTN2021 program clinical Phase I study in healthy subjects challenged with the pain-inducing ingredient (capsaicin).
All planned clinical activities for the 24 healthy male subjects have taken place in Initiator Pharma’s Phase I study in the IPTN2021 program that aims to target the treatment of trigeminal neuralgia. The study is a randomized, double‑blind, 4-way crossover placebo‑controlled study to investigate the pharmacodynamic effects of IP2015 using the intradermal capsaicin model. This study design is representative of both peripheral and neuropathic pain and constitutes an important evaluation of the pain relief properties of IP2015 before embarking on the following clinical study. The study is carried out in collaboration with MAC Clinical Research, UK, as a single site study. The obtained clinical data will now be undergoing data management, quality and statistical analysis. The data analysis will be related to the pain biomarkers collected, explore pharmacodynamic signals related to neuropathic pain and support future study designs related to trigeminal neuralgia pain. The first results are expected end of second quarter of 2022.
“I’m very pleased that we have been able to complete the in-life phase in this exploratory Phase I trial in a relative expedite manner. This is the first clinical trial in our IPTN2021 program using the drug substance IP2015 to treat pain. The trial will provide important pain related efficacy, biomarker and safety information to support the planned clinical development of IP2015. We are looking forward to receiving the data and use it to design the next clinical study aimed at the orphan drug pain indication trigeminal neuralgia.” says Claus Elsborg Olesen, CEO of Initiator Pharma.
IP2015 is the drug substance used in the Phase I study in the IPTN2021 program. IP2015 has previously shown proof of concept in erectile dysfunction. It is a monoamine reuptake inhibitor that preferentially inhibits dopamine and serotonin reuptake, thereby blocking pain sensation. IP2015 is superior to duloxetine in the rat formaldehyde pain model and the rat sciatic chronic constriction injury (CCI) model. Moreover, the safety of IP2015 is superior to duloxetine, and preclinical data showed no risk for drug interactions.
IP2015 is also the active pharmaceutical ingredient used in the IPED2015 program, which is currently undergoing Phase IIb testing in 120 patients for organic erectile dysfunction.