avantiavanti schreef op 9 januari 2019 07:34:
Alert UdatesPlus, 8 januari 2018
S1P modulator landscape becomes increasingly crowded…Phase 3 upadacitinib study in ulcerative colitis significantly delayed........
We close this alert with news on Abbvie’s JAK inhibitor, upadacitinib. Abbvie has been developing this candidate across multiple indications. The lead indication is rheumatoid arthritis with filing announced towards the end of 2018. The company has previously suggested that upadacitinib will be available for further indications in 2021 (atopic dermatitis and psoriatic arthritis) and 2022 (Crohn’s disease, ulcerative colitis and ankylosing spondylitis)
Abbvie opened a Phase 3 ulcerative colitis study in Oct 2018, randomizing 462 patients to a single dose of upadacitinib or placebo. [b]The primary endpoint of Mayo remission at 8wks was initially expected to read out around Jan 2021 however this has now been changed on CTG to July 2024. Moreover, a maintenance study has still not been posted
The timeline remains to be confirmed and if the study has been indeed been pushed back 3.5yrs reasons for this need to be understood. IBD studies have historically suffered delays due to competition for patients amongst other reasons however even by these standards today’s news is remarkable
Dr Jon Goldhill
Pharma information and reports LTD
UpdatesPlus/LeadDiscovery