IP2018 is a monoamine reuptake inhibitor for the treatment of psychogenic erectile dysfunction (mainly caused bydepression, low mood or anxiety – or caused by the pharmacological therapies these patients receive ). IP2018 is primarily targeting the serotonergic system, the dopaminergic system is targeted to a lesser extend. IP2018 is different from pudafensine in development for organic erectile dysfunction which is primarily targeting the dopaminergic system. The company intends to position IP2018 as a daily treatment for patients suffering from depression, low mood or anxiety and sexual dysfunction and/or as a supplement to treat erectile dysfunction in patients with medically (ie. antidepressant and anxiolytic therapies) induced sexual dysfunction. IP2018 is targeting a clear unmet medical need.
IP2018 raises mainly serotonin followed by dopamine levels in the brain, and in its preclinical trials, Initiator Pharma has shown that IP2018 has an effect on both erectile function and depression , which is a clear differentiation from other PDE5i on the market today. IP2018 has demonstrated an excellent safety profile in a single dose study and the proof of mechanism PET study, confirming the safety and the mechanism of action of our extensive package of preclinical data.
In June 2023 positive Phase 2a results were reported. The Phase 2a trial was a randomized, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of a low and a high dose of IP2018 in young, depressed patients who have erectile dysfunction. The primary objective of the study was to investigate the effects of IP2018 on penile rigidity and tumescence using a visual sexual stimulation test. Twenty-four patients with mild to moderate depression and erectile dysfunction completed the study. The high dose of IP2018 in single oral administration increased penile tumescence (p=0.04) and duration of rigidity (p=0.025) in a statistically significant way, sufficient for intercourse. The effect of IP2018 on erectile function was dose-dependent. In addition, no safety observations of concern was reported.
The study was conducted in collaboration with the MAC clinic, Manchester, UK.