Teva, Sanofi gain after mid-stage trial win for IBD therapy

ADRs of Teva Pharmaceutical (NYSE:TEVA) and Sanofi (NASDAQ:SNY) traded higher in the premarket on Tuesday after the companies said that their experimental antibody therapy, duvakitug, reached the main goals in a Phase 3 trial for patients with two of the major inflammatory bowel diseases (IBD).

Citing data from their Phase 2b RELIEVE UCCD study, Teva (NYSE:TEVA) and Sanofi (NASDAQ:SNY) said that patients with ulcerative colitis (UC) and Crohn’s disease (CD) witnessed statistically significant clinical improvements after receiving their TL1A-targeting monoclonal antibody.

Shares of the Israeli drugmaker jumped ~20%, while France-based Sanofi (SNY) gained ~4% in reaction.

14-week results from RELIEVE UCCD indicate that ~48% and ~36% of UC patients treated with high-dose and low-dose duvakitug achieved clinical remission, respectively, compared to ~20% of those on placebo.

Meanwhile, ~48% and 26% of CD patients treated with high-dose and low-dose duvakitug witnessed endoscopic responses, compared to ~13% on placebo.

As for tolerability, the companies said the experimental therapy was well tolerated with no safety signals. The duo has planned a Phase 3 program for the drug in IBD, subject to regulatory feedback.

“The results from the RELIEVE UCCD study have exceeded our expectations, and I am deeply moved by the potential for duvakitug to help treat and meaningfully improve the quality of life of people living with IBD,” added Eric Hughes, medical chief of Teva (TEVA).

“If the magnitude of effect persists in the Phase 3 program, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options,” noted Houman Ashrafian, Sanofi’s (SNY) head of R&D.