By Sten Stovall
LONDON--GlaxoSmithKline PLC (GSK) aims to file its experimental
once-weekly diabetes drug albiglutide for regulatory approval early
next year following the read-out from a series of clinical
trials.
The British company said Wednesday that top-line data from eight
late-stage Phase III clinical studies had now been received and,
when taken together, support advancing albiglutide to regulatory
submission.
Albiglutide is an investigational biological form of human GLP-1
and isn't currently approved anywhere in the world. Human Genome
Sciences (HGSI) discovered albiglutide and licensed it to Glaxo for
late-stage testing. The drug is a form of GLP-1--a human protein
that helps the body maintain normal blood-sugar levels.
Glaxo's regulatory filings for albiglutide will be based on a
Phase III clinical development program comprising eight individual
studies, known as Harmony 1 to Harmony 8, involving some 5,000
patients. The program is investigating the efficacy, tolerability
and safety, including cardiovascular safety, of albiglutide as
mono- and add-on therapy, in patients with Type 2 diabetes.
The latest read out came from Harmony 8, a 52-week study
comparing albiglutide with Januvia, made by Merck & Co
(MRK).
Glaxo said Harmony 8 "is the first completed study of a GLP-1
agonist to assess efficacy and safety across the spectrum of renal
impairment from mild to severe, and the third of eight Harmony
Phase III studies to complete." It said albiglutide was generally
well-tolerated.
Results from the eight studies rule out excess cardiovascular
risk, according to a threshold prespecified by the U.S. Food and
Drug Administration.
"Analyses of the data support progression to submission and will
be presented to health authorities in the coming months," the
company said.
Shares in Glaxo closed up 0.8% at 1,465 pence.
-Write to Sten Stovall at Sten.Stovall@DowJones.com