Uppsala-based Dicot continues to take decisive steps in the development of LIB-01. The phase I study with the drug candidate has now started. In the latest quarterly report, CEO Elin Trampe expresses her enthusiasm for the milestone. BioStock took the opportunity to contact Trampe in connection with the report for her view on the autumn.
Dicot develops the drug candidate LIB-01, a treatment aimed at improving the lives of the over 500 million men suffering from erectile dysfunction and premature ejaculation. The company recently announced that it has now taken the final step into the clinic with the candidate.
In August, the Swedish Medical Products Agency approved Dicot’s application to initiate its phase I study with LIB-01. This means that the study has now begun as planned in August, exactly according to the timetable that the company has communicated to the market since 2022. The first step will be to recruit participants to the first dose group.
Dicot to study safety
The purpose of the study, conducted by the CRO Clinical Trial Consultants, is primarily to study the candidate’s safety in humans. In preclinical studies, the company has been able to establish that the safety profile looks good. The study is conducted on healthy volunteers who will receive gradually increasing doses of LIB-01, first as a single dose and then as repeated dosing.
“After a successful final sprint in the second quarter, we will now meet the first people who will take LIB-01 to help us evaluate the safety of tomorrow’s potency drugs. That is really big,” the company’s CEO Elin Trampe states in her CEO statement in the report for the second quarter.
The market showed its confidence
Trampe also highlights the confidence that the market has shown in the company and the project. The biggest sign of this is that the warrants of series TO4, which had exercise in June, were subscribed for at 83 per cent – a strong outcome in a rather weak market climate. The outcome of the TO4 strengthened the company’s cash position by just over 20 MSEK, which means that the company is entering the next development phase on a stable basis.
Profit for the second quarter amounted to just over -10 MSEK and the cash position at the end of the period amounted to 54 MSEK.
Comments from the CEO
BioStock contacted Elin Trampe to find out more about how she views the past quarter and what she sees ahead of her during the autumn.
First of all, Elin, how would you like to summarise the second quarter of 2023?
– You can compare it to a sprint race, where the team worked incredibly focused and at high speed with all parallel activities to enable the start of clinical studies this August. Ever since April 2022, when we set the goal to start clinical studies in mid-2023, we have managed to tick off all sub-goals. Quarter two was the last stretch where all the final pieces should fall into place. We succeeded in this, including a capital raising round that turned out very well.
In early summer you carried out a successful capital raise with your TO4. What does this mean for the company and how do you see the financial situation going forward?
– This means that we now have the capital to initiate and conduct the phase I study. At the end of June, we had cash of just over 54 MSEK and during the autumn of this year we are carrying out the last option program that was part of our unit issue in January. We are extremely happy and grateful for the high participation in TO4 and we are very keen to manage the trust shown by our shareholders.
Looking ahead a bit, what milestones do you hope to report off once it is time to sum up 2023?
– We have very exciting things going on in several different areas. In addition to the clinical study, which has just started, work is being done on an alternative technology for future large-scale manufacturing of the drug substance. We also conduct studies on the mechanism of action of LIB-01 to demonstrate exactly how the effect and the long duration of action arise, and how the mechanism of action differs compared to today’s treatments.
– Another focus area for us is to continue to work actively to strengthen our patent portfolio and we have made several advances that we see come into fruition shortly.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.