Dicot’s CEO: “Several prominent people want to be part of the journey”
Uppsala-based Dicot recently released its Year-end report. CEO Elin Trampe notes that there is great confidence in the company’s research, both among investors and researchers in the field. BioStock contacted her in connection with the report to get a comment on the latest news and to find out more about what’s on this spring’s to-do list.
Dicot’s drug candidate LIB-01 is being developed for the treatment of erectile dysfunction and premature ejaculation. The project is originally based on a tradition of folk medicine, but LIB-01 has since been developed into a modern drug candidate. Supported by a promising preclinical data package, the company is now in the clinical development stage, where phase I studies are in full swing.
The study is being conducted by the contract research company Clinical Trial Consultants, and overall results from the single dosing phase, SAD, were recently announced. LIB-01 was found to have a very good safety profile and no serious side effects occurred. The results also show that the drug is well absorbed in the body, which gives the company a strong starting point for clinical phase II.
New phase I results in Q2
In addition to having the desired medical effect, a good safety profile is an important competitive advantage for any drug, not least for drugs that treat sexual dysfunction. Disturbing side effects are one of the problems with today’s treatments, forcing many men to discontinue their use.
The next step in Dicot’s phase I programme will be to present overall results from the second and final part of the study, where participants receive repeated and increasing doses of LIB-01. This data is expected in the second quarter of this year. After that, the clinical development will revolve around studying the drug’s effect in patients.
Great interest in the development
In Dicot’s newly released Year-end report, CEO Elin Trampe states that there is a great deal of interest in the project, both from investors and in the research community. Last year, the company signed an agreement with Dr Harin Padma-Nathan, who is a big name in the field. In addition, preclinical research results were recently presented at the European Society for Sexual Medicine’s conference – the largest conference in sexual medicine in Europe.
Dicot also did well in its investment rounds during the past year, securing subscription rates well above the industry average, in a barren financing landscape. As a result, at the end of 2023, the company had a cash position of SEK 47.3 million, ready to take the next step in its development.
New patent for new production method
An important part of the project is to ensure large-scale production. Therefore, in 2022, Dicot started a research project together with Uppsala University and the W. Szafer Institute of Botany to investigate whether the starting material in LIB-01 could be produced using plant cell cultures – an established technology for large-scale commercial production of many pharmaceutical substances that originate from nature.
According to the company, the project has led to the successful development of a specially-designed cell culture method. The project is now moving on to testing on a larger scale. At the same time, a patent application has been filed with the Swedish Patent and Registration Office to protect this method of manufacturing for the starting material. Further patent applications in other relevant markets are expected to follow.
Comments from the CEO
BioStock contacted Elin Trampe in connection with the Q4 report to find out more about what she sees ahead of her in the spring.
To begin with Elin, in your CEO statement of the report, you write that you see a very large interest in your development from several directions. What does this mean for you?
– The great interest we see from sexual medicine researchers and physicians confirms that our results are unique, and they show that LIB-01 can make a big difference. It has also helped us to get in touch with more prominent people in the field who want to participate in this journey and to contribute with their expertise, which we of course see as very positive.
How will you work to maintain that interest in the future?
– Of course, it mainly comes down to continuing to deliver good results, then the interest will automatically increase. We will also continue to be active in our communication and visit relevant conferences and forums around the world to disseminate our results in the best possible way. Having well-known experts in the field representing us in various forums also strengthens the credibility of our project.
In terms of your finances, you have a good cash position. What opportunities does that give you?
– Yes, we had a very successful year raising capital in 2023, which means that we have money to finance the company throughout phase I and it also enables all important preparations for upcoming efficacy studies in phase II.
Can you tell us more about the research project with Uppsala University and the W. Szafer Institute of Botany and why it is important?
– The project opens up a highly interesting alternative for future commercial manufacturing of the starting material for our pharmaceutical substance. The fact that the results have been successful so far means that we can now continue to evaluate the technology to a greater extent, as well as make comparisons with existing processes – where starting material is extracted from natural plant material.
How does the new production method differ from traditional methods in your field?
– The method as such of using cell culture is an already established technology for large-scale commercial production of several pharmaceutical substances derived from nature. Without going into details, we have developed a specific approach to producing and culturing cells and where we now also have enough data to be able to apply for patents and protect this way of producing our starting material.
Finally, you are now awaiting results in part two of the phase I programme. What will you focus on in the development this spring and summer?
– Yes, the final part of the study with repeated dosing, MAD, is now in full swing and we believe that we will be able to communicate results during the second quarter. In terms of clinical development, in parallel with the phase I study, we will make important preparations for clinical phase II, i.e. efficacy studies.
– Part of it is the development of the study design, which we are doing together with KOLs and interaction with the US Food and Drug Administration (FDA). It is very valuable to have an understanding with the FDA on the development program to pave the way for future market approval in the US. We are also focusing, among other things, on continued GMP manufacturing.
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.
