The first of two pivotal Phase 3 trials of a new anti-interleukin-13 drug for severe asthma has failed to meets its primary endpoint of a significant reduction in the annual asthma exacerbation rate, AstraZeneca Plc announced on 10 May.
Poxel SA has reported positive data from a Phase 2b study in Japan of imeglimin, its treatment for Type 2 diabetes. The primary endpoint of the trial was met, and was more pronounced in the Japanese patients than had been the case in similar Phase 2b trials in the US and the EU.
A Phase 3 trial of an experimental drug for relapsing-remitting multiple sclerosis, laquinimod, has failed to meet its primary endpoint which was to show an improvement in the time to confirmed disease progression.
Roche said that its kinase inhibitor Alecensa (alectinib) has produced better results in a Phase 3 trial of patients with a specific type of lung cancer than a rival treatment marketed by Pfizer Inc.
Sweden-based Medivir AB has reported positive Phase 2 data for a recently acquired histone deacetylase (HDAC) inhibitor in a trial of patients with early-stage cutaneous T cell lymphoma (CTCL), a haematologic cancer that presents in the skin.
A Phase 3 trial in which patients with active rheumatoid arthritis (RA) were treated with the monoclonal antibody sirukumab, or placebo, met its primary endpoint of relief from swelling even in those who had failed to respond to two or more biological drugs.
An early clinical trial of a candidate treatment for pancreatic cancer developed by Halozyme Therapeutics Inc has been suspended after the independent data monitoring committee determined that it was unlikely to improve the patients’ overall survival.
A Phase 2 study of the monoclonal antibody daratumumab in three types of non-Hodgkin’s lymphoma has been stopped early because it failed to reach predefined targets for overall response, Genmab A/S announced on 30 March.
Kite Pharma Inc has published further positive data for its lead chimeric antigen receptor (CAR) T cell therapy for cancer, while confirming that its rolling application to the FDA to receive marketing approval should be complete by the end of the first quarter.
The US Food and Drug Administration has given regulatory clearance for a Phase 1 trial of Cellectis SA’s allogeneic, gene-edited cell therapy for the treatment of refractory acute lymphoblastic leukaemia (ALL). The product is being developed by Servier and Pfizer Inc.