Karessa has signed an agreement with PCG Clinical Services AB for performance of a clinical study within the project K-03
Karessa Pharma Holding AB announces today that an agreement between Karessa and PCG Clinical Services AB has been signed for the performance of a first human study within the project K-03.
The study, which is the first one with Vardenafil formulated in Karessa's unique buccal film for delivery via the mucous membrane in the mouth, aim to evaluate different doses and formulations in a pharmacokinetic study on healthy human. The goal is to show which dose and formulation that are most suitable to use in a pivotal study. The start of the agreed study is scheduled to take place in the fourth quarter in 2017.
Agreement for GMP (Good Manufacturing Practice) manufacturing of clinical trial materials for this study were signed earlier this spring.
Karessa Pharma's pharmaceutical project K-03 is based on the drug molecule Vardenafil, which is the active substance in the impotence drug Levitra. The sale of Levitra, marketed as Staxyn in the United States, amounted to approximately SEK 2.4 billion in 2015.
The development of Karessa's other projects within the therapeutic area erectile dysfunction, K-01 (Sildenafil) continues according to plan.
About Karessa's pharmaceutical projects for treatment of erectile dysfunction
Current treatment of impotence is well proven and has a favorable safety profile, but many patients are bothered by the delayed onset and that it may vary depending on food intake. These problems are a consequence of the drug being given as tablets and thus has to pass the stomach and liver before reaching the right place in the body.
Karessa has developed a buccal film with the active substance Vardenafil (K-03). The film is small and is placed on the inside of the chin where it dissolves as the drug is delivered directly into the bloodstream via the oral mucosa. By this way the drug is delivered into the body and a quick and reliable onset is achieved.
Impotence affects many middle-aged men and has an increased prevalence of age. The global market for impotence drugs is estimated to a value of approximately SEK 40 billion.
This information is such information that Karessa Pharma Holding AB (publ) is obliged to disclose public according to the European Union's Market Abuse Regulation. The information was provided by the contact person below for publication on May 24, 09.00 CET.
FOR MORE INFORMATION, PLEASE CONTACT:
Michael Brobjer, CEO, Karessa Pharma Holding AB (publ)
Tel: +46 8-768 22 33
Email: michael.brobjer@karessa.se
About Karessa Pharma Holding AB
Karessa develops new pharmaceuticals based on a patented drug delivery technology and proven pharmaceutical substances in order to offer men with impotence problems a fast and more reliable effect. Karessa is listed on Nasdaq First North. For more information, please visit karessa.se
About PCG Clinical Services AB
PCG Clinical Services is a Swedish full-service CRO that is committed to developing and improving the clinical trial process. We do this through our scientific expertise, our progressive EDC system and efficient work processes. Our capabilities range from early study advice through Phase I to Phase IV trials, supported by our flexible global partner network. Our highly qualified people and our advanced data management system have been used by several of the most prominent pharmaceutical companies in their studies in many different therapeutic areas. For more information, please visit http://www.pharmaconsultinggroup.com
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