4D pharma plc (LON: DDDD), a pharmaceutical company focusing on the development of Live Biotherapeutics, has today announced that data from the completed Phase Ib clinical study of Thetanix® for the treatment of Crohn’s disease will be presented on 18 May in a poster session at the 2019 Digestive Disease Week meeting in San Diego. The poster was nominated as a “Poster of Distinction” within the top 10% of posters submitted to the congress. The Company has previously announced the top-line results from this study.
The randomised, double-blind, placebo-controlled study was conducted in two parts, with a single-dose phase and a multiple-dose phase and treated a total of 18 adolescent patients with Crohn’s disease. In the single-dose phase, eight subjects were given a single dose of either Thetanix® or placebo. In the multiple-dose phase, 10 subjects were given either Thetanix® or placebo twice daily for seven consecutive days.
This study met its primary objective, demonstrating that Thetanix® was well tolerated with a good safety profile.
The Lead Investigator Richard Hansen, Consultant Paediatric Gastroenterologist, Royal Hospital for Children, Glasgow will also give an oral presentation on this data at the 52nd Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) in Glasgow, UK, on 7 June 2019.
The poster and presentation from these meetings will be made available on the 4D pharma plc website in due course.