The Toledo program is a strategic effort to develop assets inhibiting salt-inducible kinases (SIK). Our lead molecule, GLPG3970, inhibits SIK2/SIK3 and effectuates a dual mode of action on inflammation by stimulating anti-inflammatory cytokines and inhibiting pro-inflammatory cytokines. We have observed encouraging activity in various inflammatory preclinical models with compounds targeting this class.
Our R&D Roundtable 2020 on the Toledo Program can be found here.
The development strategy for Toledo is to advance multiple Toledo candidates across different selectivity profiles, and to test these in a broad panel of in vivo disease models targeting a number of indications.
We are now executing on a broad program to discover and develop multiple series of compounds acting on the Toledo class of targets, aimed at activity across numerous conditions, with a key focus on inflammation.
In 2019 we initiated a Phase 1 trial with GLPG3970, a compound acting on SIK1/SIK2. We expect to launch multiple proof-of-concept patient trials in the second half of 2020 and expect to report topline data from our first patient study in 2021.
Gilead has an option to in-license the ex-European commercial rights to each of the Toledo molecules following completion of Phase 2 trials.