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Initiator Pharma files CTA for Phase II study with IPED2105 in Erectile Dysfunction patients

Initiator Pharma A/S, a clinical-stage life science company, announced today that it has filed a Clinical Trials Application for its planned Phase II study with IPED2105 in organic Erectile Dysfunction patients.

Initiator Pharma has filed its Clinical Trial Application (CTA) for its planned Phase II study in Erectile Dysfunction patients with IPED2015 to the Medicines & Healthcare products Regulatory Agency, MHRA, UK as well as the Ethics Committee. Pending the Covid-19 situation, an approval to initiate the patient recruitment and dosing is expected sometime in the late summer. The study will be carried out in collaboration with MAC Clinical Research, UK, at multiple centers across UK.

"Together with MAC Clinical Research, UK, we have developed and designed this comprehensive Phase II study exploring clinical relevant endpoints related to Erectile Dysfunction. This study will contribute and add supportive efficacy and safety information to the previously established Phase I/IIa Proof of Concept data", says Claus Elsborg Olesen, CEO of Initiator Pharma.

IPED2015

IPED2015 is a small molecule that in vitro inhibits the dopamine transporters (DAT), the noradrenaline transporter (NAT), and the sodium-dependent serotonin transporters (SERT). IPED2015 binds in vivo preferentially to DAT. IPED2015 is a potent inhibitor of DAT and has been found to increase dopamine in the synapses and to induce an erection in male rats. Besides, IPED2015 has been found to act through a peripheral pathway in erectile tissue, where increases in dopamine concentrations lead to the relaxation of erectile smooth muscle.

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 A/S is obligated to publish pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on 26 April 2021 at 15:45.

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. Recently, Initiator Pharma have also announced its plans to expand the clinical development pipeline to include a new program for Neuropathic Pain, more specifically the Orphan indication Trigeminal Neuralgia. 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 and 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 Psychogenic 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 Psychogenic ED - that requires 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.

Source: Cision
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