For Uppsala-based Dicot, the phase I study with the potency drug candidate LIB-01 is currently underway to investigate the safety profile in humans. The company recently completed the first part of the study and reports that it has not seen any serious side effects, and that the safety profile appears to be very good. BioStock reached out to CEO Elin Trampe to find out more.
Dicot’s drug candidate LIB-01 is being developed for the treatment of all the millions of men worldwide who suffer from erectile dysfunction and premature ejaculation. The goal of the Uppsala-based company is to develop a drug that has a longer duration, fewer side effects and that helps more people compared to the drugs available on the market today.
The project is in the early clinical stages of evaluation, where the safety is in focus. This is done in two steps, starting with single ascending doses, also known as SAD, with LIB-01. In parallel, a corresponding test is done, with participants receiving multiple ascending doses (MAD).
Just before Christmas last year, Dicot announced that the SAD results were to be released earlier than expected and be published in early 2024. Now the results are in, and it makes for positive reading for all those who follow the project.
Positive SAD results
The company states that the overall results from the SAD part show that LIB-01 has a very good safety profile. No serious side effects were observed and there was no need to limit dose escalation due to any side effects. The few side effects that could be seen were mild, dose-dependent and transient.
In connection with the announcement, Dicot also emphasises that LIB-01 is well absorbed in the body and that the oral basic formulation has thus proven to be well adapted for administration in humans.
Comments from the CEO
BioStock has contacted CEO Elin Trampe to find out more about the latest results and what expectations the company now have going forward.
To begin with Elin, you did not see any major side effects in the SAD part of your phase I study. What expectations do you now have for the MAD part of the study?
– We expect it to get good results in the MAD as well, but of course we don’t know until we have the results and can’t take anything in advance. In addition to these good SAD results, we have also seen in preclinical studies that LIB-01 appears to be well tolerated. All the information we have about LIB-01 points to that.
You saw mild side effects of transient nature. How would you relate them to the side effects seen in other erectile dysfunction drugs?
– We know that side effects are a challenge with today’s preparations, and therefore we are very pleased with these results in the SAD. The fact that there were mild transient side effects, which were dose-dependent, is a very good result.
– How? You might ask. Well, since this is a safety study, you want to make sure that the drug has been properly absorbed into the body. And when you gradually give increasing doses, you can say that it is good to see some type of side effect or “reaction” from the body. It is a kind of acknowledgment that the substance has been absorbed by the body.
– And since the reactions have been in the form of mild side effects at increasing doses and they were transient in nature, it is overall a strong result from a safety study. It is also good to keep in mind that in safety studies such as this one, doses are given that are much higher than the planned dose levels for a finished drug.
In your press release, you write that the drug uptake with your formulation is good and that it “is a good testimony to the development work and actually a bit unique in this phase” Could you elaborate a bit on what makes it unique?
– It is never self-evident that a pharmaceutical substance is well absorbed by the human body. This is why solid development work is always carried out to formulate pharmaceutical substances together with other substances, to ensure that the body can assimilate the medicine in the best possible way.
– Pharmaceutical companies often have to spend a great deal of time and money on continuing to optimise the basic formulation for clinical phase II, based on phase I data. We now have clear results in the SAD that show that we have succeeded with our formulation, that LIB-01 is absorbed very well with our current formulation.
What is the overall timetable for the continued development of LIB-01?
– We have already communicated that we may have results from the last part, the MAD, ready in the second quarter of this year. Like with SAD, the MAD results will be of an overall nature as it will take a few more weeks before we get a final report with all the statistics.
– In parallel, we are preparing as much as we can for clinical phase II, i.e. efficacy studies, so we can enter that phase as soon as possible. An important part of these preparations is interacting with the US Food and Drug Administration (FDA). It is very valuable to have an understanding with the FDA on the design and objectives of the efficacy studies. The US is an important target market and in order to pave the way for future market approval from the FDA, it is important to have them connected.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.