IPED2015 is a novel drug candidate in clinical-stage for the treatment of Erectile Dysfunction (ED)
Phase 2a clinical trial successfully completed Q1 2020
The Phase IIa Proof-of-Concept study was designed as an exploratory trial and included twelve patients who had severe Erectile Dysfunction (sED) with scores below 12 on the IIEF-5 scale, meaning that it was not possible to treat the condition with currently available treatment.
Important endpoints were the effect on the clinically relevant ability to increase and maintain the rigidity of the erection measured with Rigiscan. The effect of IPED2015 (n=12) was significant vs. placebo (n=12) on penis stiffness measured as 80-100% rigidity (P<0.05). There was also a significant effect of IPED2015 (n=12) versus placebo (n=12) on Rigidity Activity Units (base of penis: 3.50 vs. 0.83 and tip of the penis: 3.25 vs. 0.33, P<0.05), and Tumescence Activity Units (base of penis: 2.83 vs. 0.58, P<0.05 and tip of the penis: 2.17 vs. 0.42). The average events of tumescence were not different in IPED2015 versus the placebo group (base of penis: 3.49 vs. 2.80 and tip of the penis: 3.33 vs. 2.55). Thus, in the study, IPED2015 demonstrated statistically and clinically significant efficacy data on ED. The positive effects on the erectile function that were observed were closely related to the plasma concentrations and were seen in a total of 25% of the patients.
Details on IPED2015
IPED2015 has a unique dual monoamine (serotonin-dopamine) reuptake inhibition profile distinct from the known monoamine reuptake inhibitors. IPED2015 is one out of about 200 analogues that showed unique erectile properties. The knowledge about Structure Activity Relationship (SAR) within the field of monoamine reuptake inhibitors was built from about 2000 chemical structures and the range of diversity was partly illustrated in a scientific publication (Jørgensen et al. 2008). In agreement with both in vitro and in vivo measures of the ability to inhibit DA transporter function, IPED2015 induced slow-on/slow-off increases in locomotor activity when tested in mice habituated to the test environment that support a non-abuse profile. IPED2015 was found to be selective for the relevant molecular targets in the MDS LeadProfilingScreen, consisting of 67 different receptors, transporters and ion channels. In addition IPED2015 was stable in a multi-species liver microsome screen, no drug-drug interaction risk by no CYP enzyme issue, no cardiac related adverse effects in vitro (hERG) and was found to be AMES negative.