Dicot now takes the next big step in the development of LIB-01. The company has received approval from the Swedish Medical Products Agency to conduct its phase I study with the drug candidate. This means that the study will start as planned in August. BioStock contacted Dicot’s CEO Elin Trampe to find out more about the study.
Uppsala-based Dicot has the ambition to develop the drug candidate LIB-01 into the next generation of drugs for all men suffering from erectile dysfunction and premature ejaculation. The primary goal is to develop a drug with a significantly longer duration of action and fewer side effects compared to existing treatments. If successful, LIB-01 may offer a solution for the more than 500 million men currently suffering from these sexual dysfunctions.
The company’s strategy is to itself develop LIB-01 through a clinical phase IIa study. After that, they plan to collaborate with larger, established pharmaceutical companies to finance and continue the development of the candidate.
Phase I starts in August
During the spring, Dicot completed the preclinical development with the positive results from the toxicology program, where the drug candidate showed a good safety profile. The next step in the development is to take LIB-01 into clinical studies. In preparation for this, the company has previously announced that the American contract manufacturer Thermo Fisher Scientific has completed the production of the study drug to be used. The study drug has also arrived in Sweden. A clinic start with Clinical Trial Consultants has also been booked for August.
The final piece of the puzzle that needed to fall into place was to get regulatory approval. During the summer, the company managed the round of questions with the authorities that is part of the application process. This week, the company received approval from the Swedish Medical Products Agency to start the phase I study with LIB-01, a placebo-controlled study where the main purpose is to evaluate the safety of the drug candidate in humans. The approval means that recruitment of participants can now begin, followed by dosing of the first dose group.
BioStock contacted Dicot’s CEO Elin Trampe to find out more.
First of all, Elin, how does it feel that you have now been given the green light and can start your phase I study?
– Getting our application approved by the authorities is of course a really nice milestone to pass. There are several years of hard work behind an application for a clinical trial. That work is now bearing fruit in the form of us being able to take the next big step in the development of LIB-01 and begin studies in humans. With the approval in place and all other preparations ready, we are now starting the study in August, which feels great.
Can you tell us more about how the study is structured?
– It is a placebo-controlled clinical phase I trial of the type “first-in-human”. This is the first time LIB-01 has been tested in humans and the main purpose of the study is to evaluate safety, i.e., investigate the safety profile of the substance in humans.
– The study is conducted on healthy volunteer subjects where safety is evaluated at successively increasing doses of LIB-01, first as a single dose and then at repeated dosing. Some participants receive the active substance while others receive a placebo, i.e., a dummy substance. The study is double-blinded, which means that neither participants nor clinic staff know who gets what.
If we look at the timeline, how long will the study last and when do you expect to be able to present results?
– As I mentioned, the trial is initiated in August, where we start with single dosing in different dose groups. Thereafter, we will recruit and start the second part of the study, where repeated doses are given. We expect the first results of the trial to be presented in the spring of 2024.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.