Initiator Pharma A/S, a clinical-stage pharma company, announced today that all planned subjects have been included in the IPTN2021 program clinical Phase I study in healthy subjects challenged with the pain-inducing ingredient (capsaicin).
The inclusion of all planned 24 healthy male subjects has taken place in Initiator Pharma’s Phase I study targeting trigeminal neuralgia. The study is a randomized, double‑blind, placebo‑controlled study to investigate the pharmacodynamic effects of IP2015 using the intradermal capsaicin model. The study is carried out in collaboration with MAC Clinical Research, UK, as a single site study. The first results are expected during the second quarter of 2022.
“I’m very pleased that we have been able to complete the inclusion of test subjects in this exploratory Phase I trial despite the pandemic. This is the first clinical trial in our IPTN2021 program using the drug substance IP2015 to target the orphan drug pain indication trigeminal neuralgia. The trial will provide important pain related efficacy, biomarker and safety information to support the planned clinical development of IP2015 into relevant pain indications,” 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.