GSK Crohn’s disease pill fails in Phase III
pharmafile | August 27, 2013 | News story | Sales and Marketing | GSK, vercirnon
A late-stage trial of GlaxoSmithKline’s investigational Crohn’s disease drug failed to benefit patients.
The SHIELD-1 study was investigating vercirnon – a CCR9 antagonist – in patients with moderately-to-severely active Crohn’s disease.
The latest results from the Phase III trial showed the pill did not achieve the primary endpoint of improvement in clinical response, or the key secondary endpoint of clinical remission.
Vercirnon also failed to lower adverse events in patients when measured against a placebo, GSK said, adding that there was a trend for “overall adverse events to increase as dosage levels increased”.
The treatment was licensed from California-based ChemoCentryx, but the announcement of this failure wiped around $242 million, or nearly half, from ChemoCentryx’s value.
GSK bought into the drug back in 2006 when it signed a deal potentially worth $1.5 billion with the firm for new drugs to treat inflammatory bowel disease.
The London firm said in a statement that it would continue to explore the safety and efficacy results to inform decisions about the clinical development programme for vercirnon.
But it added that new recruitment and dosing in the ongoing clinical programme has been suspended, pending further review of the SHIELD-1 results.
Paul-Peter Tak, senior VP of GSK’s Immuno-inflammation R&D unit, said: “The results from the SHIELD-1 study are clearly disappointing but we are committed to further explore the data to determine the way forward to help patients with this chronic debilitating gastrointestinal disease.”
ChemoCentryx’s chief executive Thomas Schall added: “While we are clearly very disappointed with the results from the GSK SHIELD-1 study, we await GSK’s decision on the future development plan for the vercirnon programme following their further analysis of their data.”
He went on: “Other CCXI pipeline programs are moving along per plan, unaffected by the SHIELD programme. For example, in our wholly-owned lead programme, the CCR2 inhibitor CCX140, we look forward to the 12-week interim analysis from the ongoing 52-week Phase II study in diabetic nephropathy later this quarter.
“Also, we anticipate additional clinical data and an option decision in the fourth quarter of this year by GSK on CCX168, our C5aR inhibitor, which is currently in Phase II clinical development for the treatment of renal vasculitis.”
Full results from the SHIELD-1 study will be submitted to a forthcoming scientific congress and peer-reviewed scientific journal, the firms said in a statement.
Crohn’s disease is a chronic inflammatory condition of the digestive tract. It most commonly affects the lower part of the gastrointestinal tract, causing symptoms such as persistent diarrhoea, abdominal pain, fever, rectal bleeding, loss of appetite and weight loss.
It is estimated that the disease affects over 600,000 patients in North America and over 800,000 patients in Europe. Patients suffer periods of flare-ups characterised by intense symptoms, interspersed with periods of relative remission where symptoms decrease or disappear.
Current treatment options include corticosteroids, immunomodulators or biologics such as the world’s biggest selling drug Humira, marketed by AbbVie, and Merck’s Remicade.
In 2008 UCB launched its inflammatory drug Cimzia for both rheumatoid arthritis and Crohn’s disease.
Ben Adams
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