Dicot recently dosed the first participants in its phase I study with LIB-01. The main objective of the study, which takes place at Uppsala University Hospital, is to evaluate the safety profile of the drug candidate in humans. This marks an important milestone for the company, which has so far had a successful development during 2023.
Uppsala-based Dicot focuses on the development of the drug candidate LIB-01. The treatment aims to improve the lives of the over 500 million men suffering from erectile dysfunction and premature ejaculation. In August, the Swedish Medical Products Agency approved Dicot’s application to initiate its phase I study with LIB-01. Shortly thereafter, the study could be started, followed by the dosing of the first participants. This means that the company has followed the development plan that was communicated already in 2022.
Evaluating the safety of LIB-01
The phase I study is conducted by the contract research company Clinical Trial Consultants and will primarily study the candidate’s safety in humans. In preclinical studies, the safety profile has been looking good.
The study is divided into two main parts: single dosing and repeated dosing. The first part, single dosing, was recently initiated with the recruitment of the first healthy volunteers. This part of the study includes about 50 individuals who are distributed in different dose groups. Participants will be under supervision at the hospital for three days after the dose is given, for frequent safety checks, including blood tests, blood pressure and ECG. This procedure is standard for first-in-human studies.
After single dosing, the second part of the study will begin, where repeated doses will be given to each of the participants. The entire phase I study is double-blinded and placebo-controlled, which means that neither the participant nor the physician knows whether the participant has been dosed with LIB-01 or with placebo.
Anticipates an eventful autumn
”The start of the study has gone completely according to plan and it feels fantastic that the first dose of LIB-01 has now been administrated. We are so grateful to all study participants who contribute to significant research through this. It brings us closer to a new improved treatment for all men and couples who suffer from erectile problems”, Dicot CEO Elin Trampe, states in a press release.
Trampe is looking forward to an eventful autumn, where the company will continue work on an alternative technology for future large-scale manufacturing of the drug substance. Dicot will also perform studies to increase the understanding of LIB-01’s mechanism of action. The company is also focusing on strengthening its patent portfolio and has already made several advances in that direction.
Read more about the latest developments in the company here.
Comments from the CEO
BioStock contacted Elin Trampe to get a comment on the fact that the phase I study has now officially started, with the dosing of the first participants.
First and foremost, Elin, how does it feel to have started the clinical study?
– At the time of writing, dosing of the first group of participants in the study is ongoing, which is a fantastic feeling. And we notice that our enthusiasm is shared by many. It also feels very good to have received a good response on delivering according to the plan we communicated already at the beginning of 2022, now that we have started the study on time. And even the start of the clinical study has started according to plan.
What is the timeline for the study and how will you report future progress?
– We expect that results from the study can be presented in the coming spring. The study consists of two parts, single dosing (SAD) and then repeated dosing (MAD), and in order to be able to share results as soon as possible from the study, we plan to be able to publish significant results from these two parts separately.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.