Intercept Pharmaceutical Reports the results for OCA + Bezafibrate in P-II trial to treat PBC-Induced Liver Damage
Shots:
- Both P-II (714-213 & 714-214) evaluating safety & efficacy of the combination in which patients will receive QD oral therapy + UDCA (if any) in 1:1:1:1 ratio at 12wk. in 4 treatment arms: bezafibrate 200mg IR (n=19); 100 mg IR(n=11), 400mg SR (n=19); 400mg IR (n=11), 200 mg IR + OCA 5-10mg at 4wk.; 100 mg IR + OCA 5 mg & 400mg SR + OCA 5-10 mg at 4wk.; 400 mg IR + OCA 5 mg
- The result of study (714-213) depicted that at 12wk OCA5-10/B400 SR showed change is ALP by -60.6% & induced biochemical remission in 44.4% vs 31.6% in B400 SR, 31.6% in OCA5-10/B200 IR and 15.8% in B200 IR & the normalization rates of GGT, ALT and AST at 12wk were 58.86%, 94.1% and 82.4% respectively for OCA5-10/B400 SR
- Additionally the study (714-214) showed at 12wk OCA5/B400 SR changes is ALP by -65.4% & induced biochemical remission in 40% vs 18.2% in B400 IR 11.1% in OCA5/B200 IR and 9.1% in B100 IR & the normalization rates of GGT, ALT and AST at 12wk were 40.0%, 100%, and 90.0% respectively for OCA5/B400 SR
Ref: BioSpace | Image: Intercept
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
