- An experimental rheumatoid arthritis drug from GlaxoSmithKline failed to hits its primary goal in a mid-stage study, data presented at the American College of Rheumatology meeting showed, in a disappointing outcome for the pipeline candidate.
- Treatment with GSK3196165, as the drug is known, didn't result in a significantly higher proportion of patients reaching a certain disease activity score by week 24, compared to the proportion of placebo-treated patients who did. Numerically, the results favored the drug but didn't clear a statistical threshold.
- GSK, though, highlighted the rapid improvement from baseline for patients taking the anti-GM-CSF antibody, as well as "marked improvements" in patient-based measures like counts of swollen or tender joints. The pharma plans to advanced clinical development of the drug in rheumatoid arthritis.
GSK licensed GSK3196165 from MorphoSys in a 2013 deal. At the time, the drug was in Phase 1/2 testing, and GSK handed over about 22.5 million euros (about $26 million today) upfront along with potential of up to 423 million euro in milestone payments.
The candidate featured prominently in a recent review of GSK's pipeline conducted by new chief scientific officer and R&D head Hal Barron. The British pharma has lagged its peers in R&D productivity, and much of CEO Emma Walmsley's efforts to date have been aimed at revamping the company's pipeline.
Data for GSK3196165, however, looked to be more mixed to negative than GSK was likely hoping for.
The pharma tested five doses against placebo in the 222-patient study, aiming to prove the drug's benefit on a measure of disease activity called DAS28 (CRP).
At week 24, 16% of patients receiving the highest dose of the drug achieved a score lower than 2.6, compared to 3% of placebo. Despite the numerical advantage, the result failed to reach statistical significance.
For its part, GSK focused on the secondary endpoints, particularly the patient-based measures, as well as the rapid onset of action from the drug.
"We are encouraged by these results," Barron said in an Oct. 21 statement.
Adverse events were significantly higher for patients receiving drug compared to those on placebo. No treatment-limiting safety findings were identified, however.
Several other companies have taken the anti-GM-CSF antibody approach to rheumatoid arthritis, but little progress has been reported.
Kiniksa's mavrilimumab, targeting GM-CSFRα, has Phase 2 safety and efficacy in 550 patients with rheumatoid arthritis, but the company has chosen to move it forward in giant cell arteritis. Kiniksa licensed mavrilimumab from AstraZeneca's wholly-owned subsidiary MedImmune.
Morphotek's gimsilumab completed a Phase 1 trial in 2014, with results reported in 2015. But while the drug is still on the company's pipeline, there doesn't seem to have been progress since then.
Humanigen (formerly known as KaloBios Pharmaceuticals) was assessing lenzilumab in Phase 2 for use in rheumatoid arthritis, but it has focused elsewhere.