Initiator Pharma provides an update on Phase 2a progress

Initiator Pharma A/S, a biotech company that is developing a novel treatment of erectile dysfunction, today announced that the Phase 2a clinical study of IPED2015 in patients with Erectile Dysfunction is progressing well although recruitment of patients is taking slightly longer than planned. The reason for the slower recruitment is due to the aim of only including the right medically qualified and motivated patients for the trial. This delay will alter the date for the final dosing of patients in the Phase 2a, and our current best estimate for releasing draft data from the study is early Q4.

So far, the patients have tolerated the treatment with IPED2015 well with no reporting of critical safety observations in the treated patients. These results demonstrate that IPED2015 is strong drug candidate and a very valuable asset for Initiator Pharma on the brink of delivering a Clinical Proof-of-Concept for men suffering from ED. 

 `We are glad that IPED2015 is also being well tolerated by the men suffering from ED in the Phase 2a study. It is unfortunate that MAC has not been able to recruit a sufficient number of subjects over the summer holiday, however I believe we all are looking to enroll the best qualified patients in order to obtain the best Clinical Proof-of-Concept for IPED2015. We remain confident that IPED2015 will a breakthrough therapy for the PDE5i non-responders and the slow recruitment process will only delay us slightly'say CEO, Claus Elsborg Olesen.  

For additional information about Initiator Pharma, please contact: 

Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035 E-mail: [email protected] 

This information is the information that Initiator Pharma is required to disclose under the EU Market Abuse Regulation. The information was provided under the above contact person's auspices, for publication on 13 August 2019.

About Initiator Pharma

Initiator Pharma is a Biotech company established in Aarhus, Denmark. Its main asset IPED2015 represents a novel treatment paradigm for the treatment of Erectile Dysfunction (ED) and will improve the quality of life for the growing number for patients (and their partners) that do not respond or cannot be treated with the current marketed medication.

About Erectile dysfunction 

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. ED patients have decreased quality of life due to various psychosocial factors such as low self-esteem, depression, sadness, anger, frustration, anxiety,  and relationship problems (1,2, 3). 

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.