Initiator Pharma has reported positive data from the Phase IIa study evaluating IPED2015 in patients with severe erectile dysfunction (sED).
The trial demonstrated statistically significant and clinically relevant results on key efficacy endpoints in patients with sED after a single administration of IPED2015.
IPED2015 is a small molecule that in vitro inhibits the dopamine transporters (DAT), the noradrenaline transporter (NAT), and the sodium-dependent serotonin transporters (SERT).
The Phase IIa proof-of-concept study took place as an exploratory trial, including 12 patients with severe sED beyond currently available treatment.
Significant endpoints were effect on the clinically relevant ability to increase and maintain rigidity of erection measured with Rigiscan, a model used to evaluate erectile function.
Researchers conducted the efficacy assessment using the RigiScan device with stimulus challenge assessment to analyse penile rigidity and tumescence.
Rigidity Activity Units (RAU) and Tumescence Activity Units (TAU) denote significant parameters for the measurements of the rigidity of the penis as measured by RigiScan.
The trial also evaluated the safety and pharmacokinetics (PK) of IPED2015 in the subjects.
Initiator Pharma CEO Claus Elsborg Olesen said: “With the more elaborate analysis of the Proof-of-Concept IPED2015 data, we can now focus on a more comprehensive business development effort and accelerate on the closing of a deal with a potential buyer or a strategic partner.
“This will secure the continued development of IPED2015 to the benefit of the many ED patients that currently do not obtain relief by the available marketed drugs.”Initiator
Pharma notes that data from the Phase IIa trial will be used to further clinical development activities for IPED2015.