Initiator Pharma includes the first patient in Phase 2b study with IPED2015 in Erectile Dysfunction patients

PRESS RELEASE                

September 24, 2021

Initiator Pharma A/S, a clinical-stage life science company, announced today that it has dosed the first patient in the Phase 2b study in Erectile Dysfunction (ED) patients with the drug candidate IPED2015. The study is carried out in collaboration with MAC Clinical Research, UK, at multiple centers across UK.

IPED2015 is our most advanced ED program with potential to become a new treatment method for the large group of patients that do not respond to the currently marketed drugs in the PDE5i class, such as Viagra and Cialis. The dosing of the first patient in this pivotal study is a major achievement and will contribute and support the further valuable exploration and development of the IPED2015 asset,” says Claus Elsborg Olesen, CEO of Initiator Pharma.

The Phase 2b study is a randomized, double-blind, parallel-group, repeat single oral dose study of IPED2015 or placebo in otherwise healthy organic Erectile Dysfunction patients. The plan is to include 120 patients in the study divided into 3 parallel arms receiving a higher (also used in the first Phase IIa study) and a lower dose of IPED2015 and placebo, respectively, and treatment for 4 weeks with frequent assessments of erectile dysfunction, safety and pharmacokinetics. The aim is to report results from the study in H2 2022.

IPED2015 is a small molecule that preferentially binds to the dopamine transporters (DAT), and potently inhibits DAT, the noradrenaline transporter (NAT), and the sodium-dependent serotonin transporters (SERT). By binding to DAT IPED2015 increases dopamine in the brain and induces erection in rats. IPED2015 also has a a direct effect in erectile tissue, where it leads to relaxation of erectile smooth muscle. IPED2015 has successfully been through a Phase 2a Proof-of-Concept study. Results from the study support the goal of further developing an oral formulation of IPED2015 for the treatment of moderate and severe erectile dysfunction in patients who do not respond to current therapies.

For further information about Initiator Pharma, please contact:

Claus Elsborg Olesen, CEO

Phone: +45 6126 0035

E-mail: ceo@initiatorpharma.com

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 September 24, 2022, at 11:30 (CET) .

About Initiator Pharma

Initiator Pharma A/S is a Danish clinical stage life science company developing innovative drugs that target key unmet medical needs within the central and peripheral nervous system. Initiator Pharma’s pipeline consists of three clinical programs - the drug candidates IP2018 and IPED2015 for treatment of erectile dysfunction of psychogenic and organic origin, respectively, and the orphan drug candidate IPTN2021 developed for Trigeminal Neuralgia, a severe neuropathic pain condition. Initiator Pharma is listed on Spotlight Stockmarket (ticker: INIT).

Read more on www.initiatorpharma.com.

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. That number is expected to increase to more than 320 million by 2025, fuelled by aging demographics and increasing prevalence of lifestyle diseases such as diabetes and performance anxiety. The number of ED patients is most likely grossly underestimated, particularly for the Psychogenic patient segment. ED patients have decreased quality of life due to 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 Psychogenic ED – that require different treatments. Initiator Pharma is developing IPED2015 and IP2018, respectively, for these similar but separate patient segments.

  1. Shabsigh R, et al. (1998) Increased incidence of depressive symptoms in men with erectile dysfunction. Urology52(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 Med11(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.