Uppsala, November 14, 2022. Dicot announces today that the first regulatory meeting for LIB-01 prior to an application to start clinical trials has been conducted. This was the first of two planned scientific advisory meetings with the Swedish Medical Products Agency, with the purpose of anchoring the scientific background documentation for a clinical trial application.
Dicot is developing a new potency drug that aims to become the first choice for the treatment of erectile dysfunction and premature ejaculation. The company plans to start clinical trials with the drug candidate LIB-01 in mid-2023.
As part of the preparation to enter clinical phase, the company has now conducted the first of two planned scientific advisory meetings with the Swedish Medical Products Agency, with the purpose of anchoring the scientific background documentation for a clinical trial application. The scientific advice concerned central parts regarding both manufacturing and pharmacology. The next advisory meeting will focus on the design of the planned clinical trial as well as the toxicological package.
"It is an important milestone for LIB-01 and for Dicot to have completed the first formal regulatory interaction. It was a successful meeting, creating certainty in the continued work towards the planned start of a clinical trial in mid-2023", says Elin Trampe, CEO at Dicot.
For further information, please contact:
Elin Trampe, CEO
Tel: +46 739 80 14 08
Email: elin.trampe@dicot.se
About Dicot AB
Dicot is developing the drug candidate LIB-01, which will be a potency agent to better treat erectile dysfunction and premature ejaculation. The ambition is to create a drug with significantly longer effect and far fewer side effects, compared to those on the market. Today, at least 500 million men suffer from these sexual dysfunctions and the market is valued at SEK 50 billion. Research and development are conducted under own auspices up to phase 2 studies. Thereafter, Dicot's intention is to form strategic alliances, or alternatively carry out a trade sale, with larger, established pharmaceutical companies to be able to introduce LIB-01 on the world market.
Dicot is listed on Spotlight Stock Market and has approximately 3,300 shareholders. For more information, please visit www.dicot.se.
Uppsala, March 28, 2023. Dicot has now conducted the last of two planned regulatory meetings prior to an application to start clinical trials. The purpose was to anchor the scientific background documentation to be included in a clinical trial application and covered central parts of Dicot's study design to which the Swedish Medical Product Agency was positive.
Press release: Uppsala, Sweden, March 8, 2023. Dicot has entered into a consultancy agreement with medical doctor Harin Padma-Nathan, a world leading medical expert in male sexual dysfunctions. Dr Padma-Nathan was involved in the development of the drugs for erectile dysfunction currently on the market, e.g., as Lead Principal Investigator during the development of Viagra and Cialis. His Viagra paper in The New England Journal of Medicine is the most cited paper in the field of urology.
Press release: Uppsala, February 27, 2023. Dicot AB (publ) hereby publishes its year-end report for the period January - December 2022 and for the fourth quarter. The year-end report is available as an attached document and on the company's website www.dicot.se. Below is a summary of the report.
Fourth quarter 2022
- Net sales amounts to KSEK 0 (0)
- Earnings after financial items amounts to KSEK -8,604 (-8,408)
- Earnings per share amounts to SEK -0.06 (-0.10)
January - December 2022
- Net sales amounts to KSEK 0 (0)
- Earnings after financial items amounts to KSEK -31,756 (-27,175)
- Earnings per share amounts to SEK -0.26 (-0.42)
Press release: Uppsala, February 20, 2023. Dicot announces that the GMP manufacturing of the study drug for the planned phase 1 studies has begun. This is completely in line with the company's time schedule for start of clinical studies. The manufacture refers to both study drugs with active substance and placebo.
Uppsala, February 17, 2023. Today the pharmaceutical company Dicot presented the latest study of the mechanism of action of LIB-01 at the European Society for Sexual Medicine's annual congress in Rotterdam. The study shows that the mechanism of action differs from today's most common potency drugs, PDE5 inhibitors, and that LIB-01 may thus represent a completely new generation of potency drugs.
Uppsala, January 23, 2023. The pharmaceutical company Dicot AB that develops LIB-01 to become a new potency drug, today announces that it is moving forward with a new patent application. The patent application covers the new oral formulation for LIB-01 that was developed in 2022 and which will be used in the phase 1 clinical studies. This follows the IP strategy earlier communicated by the company.
Press release: Uppsala, January 19, 2023. The pharmaceutical company Dicot has contracted Thermo Fisher Scientific, the world leader in serving science, to perform GMP manufacturing of the drug candidate LIB-01 for the upcoming clinical trials.
Uppsala, January 4, 2023. The pharmaceutical company Dicot announces the contracting of reputable Clinical Trial Consultants AB (CTC) for conducting clinical phase 1 studies intended to start in mid-2023. The studies will take place at the contracted company's research clinic in Uppsala.
Uppsala, December 8, 2022. The pharmaceutical company Dicot announces that results from the latest study of the mechanism of action of LIB-01 have been selected to be presented at the European Society for Sexual Medicine's annual congress in February 2023.
Uppsala, November 15, 2022. Dicot's latest study of the mechanism of action of LIB-01, i.e., how the drug affects the body to achieve the desired effect, shows that it differentiates from today's potency drugs. This means that LIB-01 can be assumed to represent a new generation of potency drugs.