Dicot recently entered phase I with its drug candidate LIB-01, where the first step is to test single dosing on healthy volunteers. In parallel, the company is now starting the second part of the study, testing repeated dosing of the candidate. The first results from the study are expected in the spring.
Uppsala-based Dicot develops the drug candidate LIB-01 for the treatment of erectile dysfunction and premature ejaculation. Preclinical studies have previously shown promising results, both in terms of efficacy and safety. Not only have there been signs that LIB-01 has an effect, but it has also been shown that the candidate’s effect lasts for at least a week and that it seems to increase over time.
Last summer, the company was able to enter clinical studies, after the Swedish Medical Products Agency approved its application to begin phase I studies with the candidate. The study started shortly thereafter, with dosing of the first participants, in accordance with the development plan that Dicot laid out in 2022.
You can read more about the milestone here.
Will test the candidate’s safety
In this study, the focus is on the safety profile. It is placebo-controlled, with one group receiving LIB-01 and another receiving placebo. The study is also double-blinded, which means that neither the participants nor the doctors know what dose is given to each participant.
The study is carried outby the contract research company Clinical Trial Consultants and is divided into two phases: single dosing and repeated dosing. The first phase, single dosing, is underway and will include about 50 participants, divided into different dose groups.
Second part of the phase I study initiated
In parallel with the single dosing, Dicot was recently able to initiate the second part of the study, where repeated dosing is tested. The first step is to conduct a screening to find the right participants. According to the company, the study as a whole has started according to plan, where the hope is to be able to present results sometime in the spring.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.