Dicot’s phase I study fully recruited
Dicot continues to stay on schedule in its clinical phase I study. In January, the company, which is developing the next generation of potency drugs, was able to make a first positive data reading from the study, and now the last participant in the trial has been recruited.
The Uppsala-based drug development company Dicot focuses on the treatment of erectile dysfunction and premature ejaculation. During preclinical development, drug candidate LIB-01, demonstrated, among other things, that it has a longer duration of action and a differentiated mechanism of action compared to the drugs available on the market today.
Attracting attention for the results
These results have attracted a great deal of attention in the scientific community. After the autumn presentation at the Sexual Medicine Society of North America, Dicot was also invited to participate and present the results at the European Society for Sexual Medicine and the World Meeting on Sexual Medicine.
According to CEO Elin Trampe, the great interest confirms that the results seen are unique, and that LIB-01 can make a big difference for patients. They have also made contact with several prominent people in the field who want to be part of the journey and contribute with their expertise.
MAD part fully recruited
The phase I programme is currently underway. Results from the so-called SAD part of the study, i.e. the part where increasing single doses of LIB-01 are tested in healthy participants, were presented at the end of January. The overall results showed that the candidate has a good safety profile.
Dicot has announced that the recruitment of the 25 or so participants for the final MAD part, where they receive multiple doses of LIB-01, has been completed. This means that the study continues to run according to plan. Adherence to the timetable is an important aspect for Elin Trampe, who has often emphasised the importance of not being affected by delays for value creation.
“The fact that the last MAD participant has been enrolled and that the recruitment for the entire study now is completed is another important milestone that we can tick off. Our collaboration with the CRO partner CTC is exemplary, greatly assisting us in constantly being on schedule,” she writes in a comment on the latest news.
Preparing for phase II
Dicot expects to be able to present results from the MAD part during the second quarter. At the same time, preparations are underway for the next step in the development, phase II. Right now, the company is working on the study design, in collaboration with KOLs and in interactions with the FDA.
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