GlaxoSmithKline says it intends to file its investigational diabetes drug albiglutide on the back of data from seven of eight Phase III studies.
Albiglutide is an investigational once weekly glucagon-like peptide-1 (GLP-1) agonist, the same class of injectable drugs dominated by Novo Nordisk's once-a-day Victoza (liraglutide) and Amylin Pharmaceuticals' twice-daily Byetta (eventide); an extended-release formulation of the latter, Bydureon, was approved by the US Food and Drug Administration in January.
In November, GSK posted data from a late-stage study which showed that albiglutide failed to show non-inferiority to Victoza but now the UK drugs major says that other data from the Harmony programme is more impressive. Specifically, in Harmony 6, albiglutide, administered on top of Sanofi's Lantus (insulin glargine) produced clinically significant reductions in HbA1c versus preprandial lispro insulin after 26 weeks of treatment, achieving the primary endpoint.
GSK notes that two year data read-outs from five ongoing Phase III studies have been received but as they have not completed, the data "have to remain confidential to protect the integrity of the ongoing blinded studies and in line with our agreements with regulators". Nevertheless, the individual study data "provide an early indication of the profile of the investigational product, broadly aligned with the results of the two completed studies".
ViiV HIV drug impresses
Meantime, a new drug from ViiV Healthcare, the HIV joint venture set up by GSK and Pfizer, and Shionogi & Co, has impressed in a trial comparing their once-daily integrase inhibitor dolutegravir with Merck & Co's twice-daily Isentress (raltegavir).
The Phase III study met its primary objective of demonstrating non-inferiority of dolutegravir to Isentress. The tolerability of the ViiV/Shionogi drug was similar to that of raltegravir, with rates of adverse events leading to withdrawal at 2% in both arms. Drug-related nausea was reported by 10% of patients in each arm.