Interim results from Dicot’s phase I study to be released earlier than expected
Dicot’s phase I study is progressing well and the first results are now expected to be presented as early as the beginning of next year. This is earlier than the company first estimated. BioStock reached out to CEO Elin Trampe to find out what this means for the project and what she sees ahead of her when it’s time to put 2023 behind her.
Uppsala-based Dicot is developing LIB-01 for the treatment of erectile dysfunction and premature ejaculation. With over 500 million men suffering from sexual dysfunctions, Dicot is targeting a market valued at around 80 billion SEK.
The goal of LIB-01 is to offer all these men a treatment with a longer duration of action and fewer side effects than current drugs. The company’s ambition is to drive LIB-01 through clinical phase IIa study on its own and then seek partnerships with established pharmaceutical companies to finance further development of the drug for the global market.
Entered into clinic in August
In August, Dicot took the step into the clinic, completely according to the plan that was laid out already at the beginning of 2022. The ongoing phase I study is conducted in collaboration with Clinical Trial Consultants and aims to evaluate the safety profile of LIB-01 in humans. The study, which is double-blinded and placebo-controlled, consists of two parts: a single-dose phase (also called SAD) and a repeated-dose phase (also called MAD). Not long after the start of the single dose phase, the company was able to announce that it had also started with the repeated dosing.
Dicot is now providing another update, announcing that the first clinical part of the phase I study, the single-dose phase, has been completed earlier than expected. This means that the company will be able to report interim results for the SAD as early as the beginning of next year, instead of the original timetable that pointed to the spring of 2024.
In parallel, the second and final part of the phase I study continues, where the participants are given repeated dosing. Here, the company expects to communicate results in the second quarter of next year, according to the previously communicated plan.
Comments from the CEO
BioStock contacted Dicot’s CEO Elin Trampe to get a comment on the company’s success in presenting data earlier than expected.
First of all, Elin, how do you feel about being able to present results from the first part of your study already at the beginning of next year?
– We already have enough data for an adequate SAD and will therefore proceed directly to the analysis and processing of the data. We continue to show that we are doing everything we can to continue to maintain a high pace in drug development.
What does it mean for the project as a whole to be able to deliver results ahead of plan?
– This means that we receive important information about LIB-01 earlier than initially planned, a rapid and significant increase in knowledge that will guide us in the development work going forward.
Looking ahead to the next step: Given that you get good results in phase I, what steps do you need to take in preparing for phase II?
– We are already planning the study design for the upcoming phase IIa study, so much of the preparations are already being done in parallel with the phase I study. An important step is to start a dialogue with the FDA, as the US is a key market for our future product.
2023 is coming to an end. When you look back on what you have achieved during the year, what are your thoughts?
– It has been a very eventful year for Dicot, not least considering that we have now started clinical studies in humans with our potency drug candidate. We have also been successful with our financing during the year. We have kept to our plan in all parts, which feels great.
Looking ahead to 2024, what milestones do you hope to achieve?
– Next year, we will receive our clinical results from the phase I study, so it is of course a given milestone to talk about. And we plan to start a phase IIa study as soon as possible after that, i.e. in 2024. In addition to the clinical development, we have a lot of other things going on as well, for example regarding patents.
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.
