Dicot

At a conference in Arizona organized by the Sexual Medicine Society of North America (SMSNA) over the weekend, Dicot Pharma's in-depth results from the company's phase 1 study were presented for the first time.

The results were presented by Dr. Harin Padma-Nathan, who was involved in the design and results analysis of Dicot Pharma´s phase 1 study. He has been the lead study physician in over 110 clinical trials, including the development programs for Viagra and Cialis. He has also been published frequently, with an article on Viagra in The New England Journal of Medicine from 1998, still remaining the most cited in the field of urology.

The results presented showed that LIB-01 is safe and well tolerated and that an efficacy signal was captured showing a long-lasting effect with an improved erectile function that lasted for four weeks. It was the exploratory efficacy results linked to the long-lasting effect that received the most attention during the conference.

"It’s been a quarter-century of wait for a new class of oral medications for erectile dysfunction. The assembled experts at SMSNA, particularly those involved in the original Viagra research, clearly understood that a strong signal had emerged from the phase 01 study, that the wait is finally over and that the entire treatment regimen for erectile dysfunction may soon be revolutionized”, comments Dr. Harin Padma-Nathan.

In one of the dose groups where exploratory efficacy studies were performed, a clinical relevant improvement in erectile function was seen. The change in the so-called IIEF-EF domain score was 7.8 compared to baseline. The group's results showed a statistical significance (p=0.03), albeit with a limited number of participants. IIEF-EF is the established method of measuring erectile function in clinical studies. Measurements with the physical tool RigiScan® confirmed the outcome of IIEF-EF. The efficacy signal that has been achieved needs to be verified in a Phase 2a clinical study with a larger group of participants, to provide statistically validated results.

The results also show that the drug substance leaves the body quickly - also known as a short plasma half-life. After oral dosing of LIB-01, at all dose levels, plasma levels were below 3% of peak for all dose groups at 12 hours. The long duration of action combined with the short plasma half-life proves that this is a new mechanism of action that could dramatically change the treatment of erectile dysfunction, said Dr. Padma-Nathan.

For further information, please contact:

Elin Trampe, CEO
Phone: +46 72 502 10 10
E-mail: elin.trampe@dicotpharma.com

About Dicot Pharma AB

Dicot Pharma 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 study and thereafter in partnership with larger, established pharmaceutical companies, finance and develop LIB-01 further to a registered pharmaceutical on the world market.

Dicot Pharma is listed on Spotlight Stock Market and has approximately 7,200 shareholders. For more information, please visit www.dicotpharma.com.