GlaxoSmithKline (GSK) has halted a two-year-old effort to develop Galapagos’ GSK2586184 for chronic anti-inflammatory disorders, six months after it began generating disappointing results in Phase II studies—but the pharma giant told the biotech it has not given up entirely on the selective JAK1 inhibitor.
“Development options for GSK2586184 in other potential indications are presently being explored by GSK,” the company stated to Galapagos, which disclosed the anti-inflammatory development halt yesterday within its announcement of first-half 2014 financial results. GSK told Galapagos the decision followed a study of the compound’s overall risk-benefit profile.
The development halt ends R&D on GSK2586184 for systemic lupus erythematosus (SLE), ulcerative colitis, and psoriasis. GSK obtained rights from Galapagos in February 2012 to the investigational compound—then called GLPG0778—as one of two co-developed potential anti-inflammatory drugs it agreed to exclusively license from Galapagos.
At the time, Galapagos said GSK agreed to pay it an option fee of “single-digit million Euros,” as well as more than €34 million (about $45.5 million) in payments tied to undisclosed milestones, plus royalties if the compounds were successfully commercialized as new drugs. The compound was identified and progressed to a successful option exercise within 30 months, enabling the companies to progress from committing to their target to clinical Proof of Mechanism in five years, as part of a research collaboration between the companies stretching back to 2006.
GSK launched Phase II studies last year of GSK2586184 in systemic lupus erythematosus, chronic plaque psoriasis, and ulcerative colitis. In February, Galapagos said GSK halted the Phase II study in SLE at the planned first interim analysis by GSK due to a lack of effect, while putting on hold an exploratory Phase I/II study in ulcerative colitis.
Galapagos delivered better news in April, citing preliminary results that showed a significantly higher proportion of patients treated for chronic plaque psoriasis with GSK2586184 at the 400 mg bid dose met the primary endpoint compared to placebo. The primary endpoint was defined as achieving ≥75% improvement from baseline in Psoriasis Area Severity Index (PASI75) score at week 12.
“For ulcerative colitis and psoriasis, GSK has elected to terminate development principally as a result of disappointing results in a statin drug-drug interaction (DDI) study,” leading to concerns about the compound’s risk-benefit profile, Galapagos said it was told by GSK.