IPED2015, Initiator’s most advanced drug program has successfully demonstrated efficacy in a Clincial Phase 2a Proof-of-Concept study to treat patients who suffer from organic erectile dysfunction (ED) that do not respond to the currently marketed drugs in the PDE5i class (e.g. Viagra®, Cialis®, Levitra®).
IPED2015 strengthens the natural erection response by having a dual-action, both a central effect initiating erection and a peripheral effect potentiating erection through smooth muscle relaxation. IPED2015 is aimed for treatment of erectile dysfunction in patients who have erectile dysfunction due to metabolic syndrome and diabetes denoted organic erectile dysfunction. Since Initiator was founded and IPED2015 acquired, all preclinical development of the drug candidate to enable an application for clinical trials (CTA) has been carried out by the company’s auspices. IPED2015 is developed as a tablet that is taken orally. It is the company’s goal to be able to create a new “First-Line” treatment (recommended treatment) for the large group of men who have organic erectile dysfunction, but for various reasons do not respond to the currently recommended treatment with PDE5i. With the help of a competent research team, the Initiator’s main business concept is to further develop the existing drug candidate IPED2015 through successful Phase 2 studies, which will lay the foundation for a potential exit or partnership agreement.
IPED2015 is being evaluated in a Phase 2b study, which received CTA approval (Clinical Trial Application) from both the Medicines & Healthcare products Regulatory Agency, MHRA, UK and the Ethics Committee in June 2021. First patient dosed September 24th 2021. The study is conducted by MAC Clinical Research at multiple sites in the UK and is expected to be completed in the second half of 2022.