Dicot has received approval to start phase 1 clinical trial
Press release: Uppsala, August 15, 2023. Dicot announces that the Swedish Medical Products Agency has granted permission to start clinical phase 1 trial with the drug candidate LIB-01. It is a placebo-controlled trial with primary objective to evaluate the safety profile in humans.
Dicot's first-in-human study of the potency drug candidate LIB-01 has now received permission to start from the Swedish Medical Products Agency. Approval from the Ethics Review Authority has also been obtained and other preparations are complete. Screening of participants and dosing of the first dose group will start shortly.
It is a placebo-controlled phase 1 clinical trial where the primary objective is to evaluate LIB-01's safety profile in humans. The trial evaluates the safety following increasing doses of LIB-01 in healthy participants, both as a single ascending dose (SAD) and multiple ascending doses (MAD).
"The approval is of course an important milestone for us to pass and means that we can start the phase 1 study according to schedule. It is fantastic to finally get started and we expect the first results from the study to come during spring 2024," says Elin Trampe, CEO of Dicot.
For further information, please contact:
Elin Trampe, CEO
Phone: +46 739 801408
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 4,400 shareholders. For more information, please visit www.dicot.se.