clonidine/oxybutynin (OP-014) / Orient Europharma - LARVOL DELTA

MOLECULAR RESPONSE TO HYDROXYUREA AND ROPEGINTERFERON ALFA-2B IN THE PROUD-PV RANDOMIZED PHASE 3 TRIAL (EHA 2017) - P3; "In this phase 3 trial comparing Ropeginterferon alfa-2b versus HU, we found a different impact of both drugs on hematopoietic cells. Although both treatment induced a decrease of JAK2 mutant allele burden at 12 mos in peripheral blood, BM clonogenic assays suggest that AOP2014 is able to specifically target JAK2 mutant progenitors, an effect not seen in HU treated pts. Such targeted impact of AOP2014 may account for the strikingly different kinetics in allele burden reduction and suggests that sustained long-term molecular response may only be achieved with IFNa based treatment."

P3 data • Biosimilar • Myelodysplastic Syndrome

CONTI-PV: AOP2014 in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study. (clinicaltrials.gov) - P3; N=170; Active, not recruiting; Sponsor: AOP Orphan Pharmaceuticals AG; Recruiting ➔ Active, not recruiting; N=130 ➔ 170

Enrollment change • Enrollment closed • Biosimilar

Improved endoscopic outcomes and mucosal healing of upadacitinib as an induction therapy in adults with moderately to severely active ulcerative colitis: data from the U-ACHIEVE study (ECCO-IBD 2019) - "The proportion of patients achieving endoscopic improvement, endoscopic remission, histological improvement, histological remission, and mucosal healing was statistically significantly higher (p < 0.05) in the upadacitinib 30 and 45 mg QD groups vs. the placebo group (Table).Abstract OP014 – Table. Proportion of patients achieving endoscopic improvement, endoscopic remission, histological improvement, histological remission, and mucosal healing at Week 8. Conclusion In this dose-ranging 8-week induction study, upadacitinib 30 and 45 mg QD consistently demonstrated significant improvement in endoscopic outcomes, histological outcomes, and mucosal healing compared with placebo in patients with moderately-to-severely active ulcerative colitis."

Clinical