4D pharma’s Chron’s treating Thetanix meets objective
May 16, 20194D pharma’s study of Thetanix for treating Crohn’s disease has met primary objective, as it showed Thetanix was well tolerated with a good safety profile.
The 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 company said in a Thursday press release. 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.
According to DDDD, 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, the company explained.
The Lead Investigator Richard Hansen, Consultant Paediatric Gastroenterologist, Royal Hospital for Children, Glasgowwill also speek about this at the 52nd Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) in Glasgow, UK, on 7 June 2019.
