In August the pharmaceutical company Dicot will take a decisive step in its development. The plan is to initiate the clinical phase I study with the drug candidate LIB-01. Prior to this, the exercise of the warrant TO4 is currently ongoing and BioStock talked to CEO Elin Trampe about her reflections.
Uppsala-based Dicot continues its development work of LIB-01, with the ambition to introduce a modern improved solution for the treatment of erectile dysfunction and premature ejaculation. The company’s goal is to develop a drug with a longer duration, fewer side effects and that helps more people compared to current drugs.
Dicot strives for LIB-01 to become the first choice in the treatment of erectile dysfunction and premature ejaculation, thus improving the quality of life for men suffering from these conditions and their partners.
Preparing for phase I
After positive results during the spring in the preclinical toxicological program, full focus is now on starting a clinical phase I study, which is scheduled for August. The company recently submitted the application to the Swedish Medical Products Agency. Learn more.
In order to carry out the study according to plan, it is important that the company is financially stable. During the first quarter, Dicot carried out a successful rights issue securing approximately 55 MSEK. Despite the challenging environment in the capital markets, the issue was oversubscribed by 10 per cent – showing a strong interest for the project.
The exercise Dicot’s series TO4 warrants is currently running – the exercise period ends on June 15. Each TO4 entitles the holder to subscribe for one new share in the company at 0.11 SEK. Should all TO4 warrants be exercised, Dicot will receive approximately 24.8 MSEK. Recently, the company announced that management and the board of directors as well as major shareholders have committed to exercise their warrants, corresponding to approximately 3.9 MSEK.
BioStock contacted Dicot’s CEO Elin Trampe to get her thoughts on the project and about the current capital raise.
Phase I is mainly to establish that LIB-01 is safe, but will you also be able to measure efficacy already in this study?
– In this phase I study, we are looking at safety, and that is how the first study in humans must be structured. The safety profile is the first to be evaluated. This phase I study is therefore not an efficacy study. The dose levels, dose procedure and number of participants in the study are set to evaluate the safety of LIB-01 in humans.
– To the extent that we can possibly see an effect, it will primarily be able to contribute important information for future efficacy studies in phase II and possibly provide clues about the mechanism of action.
In terms of effect, what have you seen so far?
– We have clearly seen the effect of LIB-01 in our preclinical studies. The studies have been conducted in validated models by a world-leading CRO in the field, which also worked for Pfizer in the development of Viagra. The effect has also been shown to last for a long time, which is something completely unique If you could take a long-acting drug allowing you to be more spontaneous, it would normalise your sex life.
You are currently exercising your TO4 series and have another warrant, TO5 this autumn. What is behind this arrangement?
– We made a successful rights issue of units in January this year. And in connection with it, these two series of warrants were issued. With the warrants, you have the right to subscribe for new shares in Dicot, where TO4 has a subscription period now until June 15 and TO5 has a subscription period later this year, November 1 – 15.
For those interested in participating in your TO4 exercise, what do you need to do?
– If you were not participating in the issue in January and received warrants there, the warrants are listed on Spotlight Stock Market, they can be purchased until June 13 under the ticker “DICOT TO 4” via, for example, Avanza, Nordnet or another bank. We have more detailed info on our website and there are also instructions on how to convert these warrants into shares.
Looking at the project at a slightly longer term, what is your strategy?
– The goal is, of course, for our candidate to become a drug on the world market. We address a global problem, and our aim is to be available in as many markets as possible. The business strategy is to develop LIB-01 in-house through clinical phase IIa, and to then develop it onwards in partnership with major established pharmaceutical companies.
– This is also an important part of the financing strategy as we expect upfront payments when signing these partner agreements, and then milestone payments when milestones are achieved.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.