Positive results from the first part of Dicot's phase 1 study
Press release: Uppsala, Sweden, January 23, 2024. Dicot presents positive results from the first part of its phase 1 clinical study showing that LIB-01 has a very good safety profile. There were no serious adverse effects. The results also show that the drug is well absorbed in the body, which puts the company in a strong position for clinical phase 2.
The primary objective of Dicot's phase 1 study is to investigate the safety of the potency drug candidate LIB-01 in humans. The study is double-blind and placebo-controlled and consists of two parts: SAD and MAD. The SAD part studies increasing single doses of LIB-01 regarding safety parameters such as adverse effects as well as how well the drug is absorbed in the body. In the MAD part, the same assessments are done, but with repeated dosing.
The company today announces the first overall results from the SAD part, showing a very good safety profile. There were no serious adverse effects, and the dose escalations were not limited by adverse effects. There were only a few mild and transient, dose-dependent adverse effects reported from participants receiving LIB-01. The study also shows that the drug is well absorbed with good exposure in the body, which confirms that the oral formulation chosen is suitable for administration of LIB-01 to humans.
As the company previously announced the results from the MAD, the second and final part of the phase 1 study, will be published in the second quarter of 2024.
"It is fantastic to be able to present such a good safety profile from our very first study in humans. We are very pleased to have reached such an important milestone in the development of LIB-01. The fact that the drug is well absorbed with our oral formulation is a strong outcome of the development work and somewhat unique in this phase. It means that we are very well positioned for clinical phase 2," says Elin Trampe, CEO of Dicot.
For further information, please contact:
Elin Trampe, CEO
Phone: +46 72 502 10 10
E-mail: 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 current available drugs. Today, over 500 million men suffer from these sexual dysfunctions and the market is valued at USD 8 billion. Dicot's strategy is to develop LIB-01 under own auspices until phase 2a studies and thereafter in partnership with larger, established pharmaceutical companies, finance and develop LIB-01 further to a registered pharmaceutical on the world market.
Dicot is listed on Spotlight Stock Market and has approximately 5,000 shareholders. For more information, please visit www.dicot.se.
This disclosure contains information that Dicot AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 23-01-2024 11:59 CET.