Initiator Pharma, a Biotech Company developing a novel treatment of Erectile Dysfunction (ED), has today filed a Clinical Trial Application, CTA for Drug candidate IPED2015 with the Medicines & Healthcare productsRegulatory Agency, MHRA,UK.
"We are really pleased with the completion and the filing of the CTA. This represents an important milestone for Initiator Pharma and we are now on the brink of becoming a Clinical stage company." says Claus Elsborg Olesen, CEO of Initiator Pharma.
Following the completion of the GMP qualified CMC development activities and ICH directed GLP qualified non-clinical safety studies in January Initiators Pharma's development team has ensured a high quality and diligent process leading to this CTA submission.
Initiator Pharma expects to obtain an approval for initiating a Phase 1 study during the coming months.
"We are confident that the CTA filing will enable us to start the clinical trials this summer, as scheduled" says Claus Elsborg Olesen, CEO of Initiator Pharma.
For additional information about Initiator Pharma, please contact:
Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035 E-mail: [email protected]
Initiator Pharma is required to disclose the present information under the EU Market Abuse Regulation. The information was provided under the above contact person's auspices, for publication on 23rdof May 2018
About Initiator Pharma
Initiator Pharma is a Biotech company established in Aarhus, Denmark. Its main asset IPED2015 represents a novel treatment paradigm for patient suffering from Erectile Dysfunction (ED) and will improve the quality of life for the growing number for patients (and their partners) that do not respond to the current market PDE5i medications like Viagra, Cialis and Levitra. Initiator Pharma is listed on AktieTorget, Sweden and has about 3400 shareholders. The company's share is traded under the ticker INIT. Learn more at initiatorpharma.com
About Erectile dysfunction
Erectile dysfunction is 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. The large diabetic ED patient segment is often responding poorly to the current medication and is therefore of particular interest for Initiator Pharma. ED patients have decreased quality of life due to various psychosocial factors such as low self-esteem, depression, sadness, anger, frustration, anxiety, relationship problems etc. (Althof, 2002; Shabsigh et al., 1998, Tsai, 2008; Litwin et al., 1998)