Erectile dysfunction is defined as the inability to obtaining an erection sufficient for sexual intercourse and affects a high and increasing number of men. The scientists in Initiator Pharma have a long track record in research in erectile function and have tested several potential drug candidates in preclinical models for erectile dysfunction. Current guidelines recommend phosphodiesterase type 5 (PDE5) inhibitors, sildenafil, vardenafil and tadalafil, as the first line treatment of erectile dysfunction. PDE5 inhibitors have mainly a direct peripheral effect, where they by inhibition of PDE5 increases erectile tissue content of cyclic GMP and leads to relaxation of the erectile tissue followed by erection. PDE5 inhibitors potentiate the physiological mechanisms leading to erection. However, approximately 40% of men with erectile dysfunction do not respond to drug therapy (Gupta et al, 2005). Patients suffering from neurologic damage, diabetes mellitus or severe vascular disease may be resistant to PDE5 inhibitors Kendirci et al 2006 and Dhir et al 2011. In addition to these diseases, medications of central nervous system disorders, like antidepressants, antipsychotics and anxiolytics, have also negative impact on the erectile function Gratzke et al 2010.
IPED2015 by having a dual action, both a central effect initiating erection and a peripheral effect potentiating erection through smooth muscle relaxation, is unique and aimed for treatment of erectile dysfunction in patients suffering from erectile dysfunction due to metabolic syndrome and diabetes. In addition, the initiator mechanism can be used in combination with other treatments for erectile dysfunction. The strategy is to generate Clinical activity data in Phase II trials and then seek further investments and partnerships to launch the drug for treatment of erectile function.