KBC Securities 10/11:
Galapagos announces first dosing of a psoriasis patient in a phase Ib trial with GLPG3667. The company envision’s Toledo-like development, with phase II studies in PsA and UC anticipated in 2H21. While the compound’s MoA remains undisclosed, Galapagos has fostered long- time ambitions in TYK2(/JAK1)-targeting compounds.
Yesterday evening, Galapagos announced the start of a phase Ib trial with GLPG3667 in psoriasis patients. GLPG3667 has a yet to be disclosed mode-of- action aimed at treating inflammatory conditions. The compound completed an initial phase I study in healthy volunteers and now proceeds in development, with a first psoriasis patient dosed. The phase Ib study is a randomized double- blind and placebo-controlled study taking place within Europe and will include 30 patients. Patients will be receiving either placebo or one of two dose levels of GLPG3667 in a 4-week once daily treatment regimen. Primary endpoint is the change from baseline in the PASI score after 4 weeks.
Galapagos anticipates to further develop GLPG3667 in phase II dose range finding studies in both psoriatic arthritis (PsA) and ulcerative colitis (UC) in the second half of 2021.
Galapagos adds another clinical candidate to its roster of potential drugs in the inflammation and fibrosis fields. Considering the envisioned path forward for GLPG3667, the compound seems to be getting the star treatment as clinical development parallels the trajectory foreseen for prioritized Toledo compound GLPG3970. Also this compound has started a phase Ib trial in psoriasis to rapidly collect data and then move into no less then 5 phase II dose range finding studies. Interestingly, GLPG3667’s phase Ib in psoriasis patients is shorter compared to that of GLPG3790 (4 weeks vs 6 weeks) but is set to include slightly more patients (30 pts vs 25 pts).
While the compound’s MoA remains undisclosed, Galapagos has maintained ambitions developing a TYK2-targeting compound, either fully TYK2 specific or TYK2/JAK1, with initial TYK2/JAK1 compound GLPG3121 having been discontinued due to undesirable pharmacokinetics back in 3Q19.
TYK2 has remained in focus as an anti-inflammatory target with development ongoing at big pharma such as Bristol Myers-Squibb (BMS) and Pfizer. BMS took a chance on its internal TYK2 program after it was forced to divest an inflammation asset due to the merger with Celgene, opting to divest Celgene’s Otezla (sold to Amgen for $ 13.4bn) and retain its internal TYK2 program deucravacitinib. BMS’ compound has completed 2 phase III trials including a head-to-head comparison with Otezla. BMS has announced deucravacitinib has bested Otezla, but has yet to reveal the data. Not unlike GLPG3667’s envisioned trajectory, deucravacitinib is in development for psoriasis (phase III), followed by earlier stage trials in PsA, UC and SLE (phase II). Also Pfizer’s TYK2/JAK1 compound brepocitinib is on the cusp of a critical phase II readout in psoriasis patients.