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.
Erectile dysfunction (ED) 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 322 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, relationship problems etc. (Althof, 2002; Shabsigh et al., 1998, Tsai, 2008; Litwin et al., 1998).
The development and launch of PDE5i products such as Viagra© and Cialis© have dramatically improved the Quality of Life for men that respond to this treatment, improving the mood, overall sexual function, satisfaction in relationships and their overall Quality of Life (Rosen et al., 2004; Shabsigh et al., 2001). Unfortunately, approximately 30-40% of men with ED do not respond to the PDE5i drug therapy and this group of patients still experiences low Quality of Life (Gupta et al, 2005). Patients suffering from neurologic damage, diabetes mellitus or severe vascular disease are particularly at risk (Jackson et al, 2006), in addition to patients on medications of central nervous system disorders, like antidepressants, antipsychotics and anxiolytics function (Gratzke et al, 2010). New alternative therapies are clearly needed for this medical condition.
Initator Pharma targets the non-responders to PDE5i drugs, a potential market of around 100 millon men in 2025 where current therapies offer very limited opportunities to maintain a normal sexual life. Our drug candidate IPED2015 exerts its action through a novel mechanism targeting central neurotransmitters. In addition to offering a novel mechanism with the potential to help non-responders to drugs in the PDE5i class, we believe IPED2015 is likely to reduce the side-effects of the current treatment.
Initiator Pharma is established as a Spin Off based on assets from Saniona AB – an ion channel drug discovery company listed on the Swedish Stock Exchange First North a multilateral trading facility (MTF), (Saniona at www.firstnorth.se). The asset comes with a large preclinical and early clinical package that Initiator Pharma has combined with a highly experienced ED research group and specific competencies with conducting preclinical, clinical development and regulatory approval. This combination represents a unique opportunity to attain a Clinical Phase IIa Proof-of-Concept in 2019.