Thetanix (bacteroides thetaiotaomicron) / 4D Pharma, CJ Biosci - LARVOL DELTA

A Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability of (Thetanix) Bacteroides thetaiotaomicron in Adolescent Crohn's Disease. (PubMed, Clin Transl Gastroenterol) - "Thetanix, after single and multiple doses, was well tolerated. Although the numbers in this study were small, the safety profile seems good. Future studies should explore efficacy."

Clinical • Journal • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Pain • Pediatrics • PCR • TNFA

Study of Bacteroides Thetaiotaomicron in Young People Aged 16 to 18 Years With Stable Crohn's Disease (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: 4DPharma PLC

New P1 trial • Biosimilar • Crohn's Disease • Immunology • Inflammatory Bowel Disease

A phase I randomised, double-blind, placebo-controlled study to assess the safety and tolerability of (Thetanix®) Bacteroides thetaiotaomicron in adolescents with stable Crohn´s disease (ESPGHAN 2019) - "Thetanix® , after single and multiple doses, was well tolerated. There were no TESAEs or deaths and all subjects completed. There were no trends in laboratory results or vital signs to suggest an adverse effect."

Clinical • P1 data

4D presents phase Ib clinical data on Thetanix (PRNewswire) - "4D pharma...announced that data from the completed Phase Ib clinical study of Thetanix® for the treatment of Crohn's disease will be present....The Lead Investigator Richard Hansen...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.ed on 18 May in a poster session at the 2019 Digestive Disease Week meeting in San Diego."

P1 data

A Phase I Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of (Thetanix®) Bacteroides Thetaiotaomicron in Adolescents with Stable Crohn’s Disease (DDW 2019) - "Thetanix®, after single and multiple doses, was well tolerated. There were no TESAEs or deaths and all subjects completed. There were no trends in laboratory results or vital signs to suggest an adverse effect."

Clinical • P1 data