One of GlaxoSmithKline’s $GSK top pipeline candidates has failed a Phase II trial — badly.
The pharma giant reported today that their anti-GM-CSF — GSK3196165, held up as a top drug candidate by new R&D chief Hal Barron in a recent interview — failed the primary endpoint of DAS28(CRP) < 2.6 at Week 24.
GSK did pull out some positive secondaries, but in an intensely competitive field where other players have been touting much better, statistically significant primary goal results, the future of this drug is very much in doubt.
The key disease activity score registered for only 16% of the patients taking the high dose of the drug, significantly better than the minimal number on placebo. That was a p-value of only 0.134, however.
Last April AbbVie $ABBV reported clinical remission (<2.6) of 29% based on patients’ DAS28 in a Phase III for upadacitinib at week 12, beating out adalimumab at 18%. And Gilead $GILD reported a 30.6% DAS28(CRP) < 2.6 score at their high dose for filgotinib at week 24, almost twice the GSK number.
For Barron, though, evidence of early efficacy with the hits on secondaries for DAS28(CRP) change from baseline at week 12 and an improvement in efficacy through the EOW dosing phase that was statistically significant at Week 24 are grounds for optimism.
And they add that in a separate 12-week study they saw a “similar clinical efficacy profile and in addition synovitis reduction was observed in patients with RA.”
About half of the patients taking their drug — obtained from MorphoSys — experienced adverse events, some serious.
Weak and bad data are not what GSK needs right now, particularly in RA, where the company has not been seen as a player in the showdown between AbbVie and Gilead. The company badly needs new blockbusters, not another last place finisher with marginal prospects.
“We are encouraged by these results,” remarked Barron in a statement. “The rapid onset and marked benefit on clinically meaningful endpoints such as pain and swollen tender joint counts, represents a potentially important advance for patients with rheumatoid arthritis who are in need of new treatment options.”
GSK made it clear that the R&D team plans to push ahead with more studies on this drug, despite the Phase II failure. It’s a difficult case to make at a time the company needs to line up odds-on winners.
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