Initiator Pharma A/S, a clinical-stage biotech company that is developing a novel treatment of psychogenic erectile dysfunction (ED), today announced that it has received a commitment from Innovation Fund Denmark to support the clinical development of IP2018. The Innobooster grant will fund the ongoing IP2018 phase 2a clinical trial with up to 3.8 MDKK.
IP2018 is a candidate drug being developed for the treatment of sexual dysfunction in patients with major depressive disorder or more generally psychogenic ED. The Phase 2a trial is a randomized, double-blind, placebo-controlled, 3-way crossover trial studying the efficacy and safety of IP2018 in young, depressed, ED patients. The primary objective of this study is to investigate the effects of IP2018 on penile rigidity and tumescence using visual sexual stimulation test. The study will be conducted in 24 patients at the MAC Phase I unit in Manchester, UK. Pending the Covid-19 situation first dosing to patients is expected to take place shortly.
“We are delighted that Innovation Fund Denmark has decided to make this investment through their Innobooster program. It is a clear validation of Initiator Pharma’s unique candidate drug IP2018 and the need for improved treatment of psychogenic ED. We remain confident that IP2018 will be a breakthrough therapy for psychogenic ED and look forward to demonstrate this in our ongoing phase 2a clinical trial,” said Claus Elsborg Olesen, CEO at Initiator Pharma.
For additional information, please contact:
Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035
This information is the type of information that Initiator Pharma (Ltd.) is obligated to publish pursuant to the EU Market Abuse Regulation. The information was provided by the contact person above, to be published on November 5, 2020, at 22:00 (CET).
About Initiator Pharma
Initiator Pharma is a clinical-stage biotechnology company based in Aarhus, Denmark. The company’s main clinical Phase assets are IPED2015, intended for patients with erectile dysfunction, and IP2018, for the treatment of psychogenic erectile dysfunction. The treatments both represent First in Class treatments for psychogenic and organic ED, respectively, and are expected to improve the quality of life for a growing number of patients who are not responding to or cannot be treated with existing drugs on the market. Read more on www.initiatorpharma.com.
IP2018 is a monoamine reuptake inhibitor that inhibits the synaptic reuptake of serotonin, noradrenaline, and dopamine. IP2018 preferentially inhibits serotonin followed by dopamine reuptake, while it has markedly less effect on the noradrenaline reuptake. IP2018 has antidepressive effect in animal models for depression and effect on erectile function. There is solid preclinical data package, a phase I study, and a positive emission tomography (PET) study showing binding in patients to the serotonin reuptake and dopamine reuptake transporter.
About Erectile dysfunction (ED)
Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual activity. ED affects more than 150 million men worldwide and that number is expected to increase to more than 320 million by 2025, fueled by aging demographics and increasing prevalence of life style diseases such as diabetes, and performance anxiety. The number of ED patients is most likely grossly underestimated, particularly for Pscyhogenic patient segment. ED patients have decreased quality of life due to various psychosocial factors such as low self-esteem, depression, sadness, anger, frustration, anxiety, medication and relationship problems (1,2, 3). Erectile dysfunction can be divided into two main categories – Organic and Pscyhogenic ED – that requires different treatments. Initiator Pharma is developing IPED2015 and IP2018, respectively, for these similar but separate patients segments.
1. Shabsigh R, et al. (1998) Increased incidence of depressive symptoms in men with erectile dysfunction. Urology 52(5):848–852.
2. Mccabe MP, Althof SE (2014) A systematic review of the psychosocial outcomes associated with erectile dysfunction: Does the impact of erectile dysfunction extend beyond a man’s inability to have sex? J Sex Med 11(2):347–363.
3. Nguyen HMT, Gabrielson AT, Hellstrom WJG (2017) Erectile Dysfunction in Young Men—A Review of the Prevalence and Risk Factors. Sex Med Rev5(4):508–520.