Phase I is approaching for Dicot
Many follow Dicot’s development with eager anticipation. After this winter’s share issue, the company now announce good results from the completed toxicological program. The phase I clinical trial is expected to start in August. BioStock contacted Dicot’s CEO Elin Trampe to find out more.
Dicot develops the drug candidate LIB-01 for the treatment of erectile dysfunction and premature ejaculation. The Uppsala-based company is targeting a billion-USD market currently dominated by PDE5 inhibitors such as Viagra. LIB-01 is seen as a completely new type of erectile dysfunction drug with a longer duration and fewer side effects, hoped to become the first choice for affected men and couples.
The long duration is something that caught the industry’s eye. The market for erectile dysfunction drugs has not had any breakthroughs since Viagra’s introduction. According to Dicot, a lot of people in the industry regard LIB-01 as a potential game changer.
Good results in the tox studies
The company is currently about to enter the clinical phase of development. Recently, Dicot announced good results from the toxicology program needed for the clinical start. Following current regulations, studies have been conducted in two animal species that support both single and repeated dosing in the clinical studies. LIB-01 showed a good safety profile in the toxicology studies, which means that the company can now proceed.
Start of the phase I booked for August
Dicot has previously aimed to start the phase I study sometime in mid-2023. Having come far enough in its preparations, the company now dares to specify more precisely – the study is expected to start in August. To ensure this, Dicot has reserved capacity with CTC, the CRO that will conduct the study.
Meanwhile, GMP production of the study drug is underway at manufacturing partner Thermo Fisher Scientific. The final step will be to submit documents to the Swedish Medicines Agency, which will have to give its go-ahead before initiating the study.
Comments from the CEO
BioStock contacted Dicot’s CEO Elin Trampe to find out more about what the latest news means for the project.
First of all, after all the work done, how does it feel to stand on the verge of clinical studies with LIB-01?
– Of course, it is very gratifying! We have succeeded in realising our development plan with LIB-01 with good solid preclinical results and are now really looking forward to being able to start the first study in humans with our drug candidate.
Given the results so far, what risks do you see in LIB-01 not making it through this important development phase?
– The first clinical study, phase I, aims to evaluate safety in humans. With the good results from the preclinical toxicology program and the fact that our drug substance originates from folk medicine use, we look forward to the results with great confidence.
How long do you expect the phase I study to last?
– In general, a clinical phase I study is completed in about a year, but I hope and believe that we can do it faster than that. We will make sure to return to the market with a more precise timetable for the completion of the study and reporting of study results.
Given that you get the results you want, can you tell us about the next step with the candidate?
– The next step after phase I will be to proceed with clinical phase II studies as quickly as possible. The first thing you want to do there is to show the effect of the drug candidate in humans, a so-called proof-of-concept study, and then determine appropriate dose levels.
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.
