A Phase 4 post-marketing trial of the Type 2 diabetes drug Onglyza (saxagliptin) in patients with a history of cardiovascular disease met the primary safety objective of non-inferiority, but did not show superiority versus placebo, the sponsors said.
Eli Lilly and Company has stopped a Phase 2 study of a beta secretase inhibitor being investigated in Alzheimer’s disease as a result of abnormal liver tests in patients. The decision doesn’t affect other compounds in development, the company said.
AstraZeneca Plc has said it will not seek to register fostamatinib, a spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis, following disappointing results from a Phase 3 programme. It will return rights to its partner, Rigel Pharmaceuticals Inc.
Advanced Accelerator Applications (AAA) SA of France has raised €4.8 million in a placement of its shares with existing and new investors in order to finance an expansion of its manufacturing capacity for radioactive agents for Positron Emission Tomography (PET) imaging. Funds will also be used to investigate a second indication for the company’s radiopharmaceutical for cancer, Lutathera.
The Wellcome Trust is allocating £2.7 million to a UK project that will use new gene sequencing technology to identify mutations that predispose patients to cancer and then to integrate this information into routine patient care.
AbbVie Inc (formerly part of Abbott Laboratories) is expanding its collaboration with Galápagos NV of Belgium to take the Galápagos JAK1 inhibitor, GLPG0634, into Crohn’s disease. The molecule is already being investigated for rheumatoid arthritis.
Sanofi SA said that its JAK2 inhibitor for myelofibrosis met its primary endpoint in a Phase 3 pivotal study. The placebo-controlled study was conducted in 24 countries under a Special Protocol Assessment with the US Food and Drug Administration.
Tocilizumab (Actemra/Roche) has been shown to be superior to adalimumab (Humira/Abbott) in a head-to-head Phase 4 study in patients with rheumatoid arthritis, according to an article in The Lancet on 4 May 2013. The article appeared earlier on-line.
In another example of Big Pharma collaboration in the area of diabetes, Merck & Co Inc has announced plans to collaborate with Pfizer in the development and commercialisation of ertugliflozin, a Phase 3-ready diabetes drug in the SGLT2 class.
MorphoSys AG has initiated a Phase 2 study of its proprietary antibody, MOR208, for patients with B-cell acute lymphoblastic leukaemia. The antibody is one of three in the clinic from the company’s internal portfolio. The study is taking place in the US.