Clinical Research

A Phase 3 trial of a lipid-lowering drug involving more than 13,000 patients has been discontinued after the study’s monitors concluded the medicine was unlikely to deliver benefits to patients. The sponsor, AstraZeneca Plc, was attempting to show that patients with mixed dyslipidaemia who are at risk of cardiovascular disease could be helped by Epanova (omega-3 carboxylic acids), a compound derived from fish oil. The patients were all on optimal statin therapy. But the independent data monitoring committee concluded that a benefit was unlikely.

Germany-based Medigene AG has reported positive top-line data from an early clinical study of a dendritic cell vaccine for cancer which showed both safety and tolerability as well as early signs of efficacy. The vaccine was administered to 20 patients with acute myeloid leukaemia, of whom half were 60 years of age or older. This patient cohort is often ineligible for haematopoietic stem cell transplantation and has poorer treatment outcomes, the company said. The balance of patients were younger than 60 years.

A Phase 3 study of the checkpoint antibody Tecentriq (atezolizumab) did not meet its primary endpoint of disease-free survival compared with observation in patients with muscle-invasive urothelial cancer, the developer Roche announced on 24 January.

An experimental treatment for Type 1 spinal muscular atrophy (SMA) has reached its primary endpoint in a pivotal trial of infants, paving the way for a US regulatory decision by late May, according to the developer Roche. The drug, risdiplam, is a small molecule that works by increasing the amount of protein produced by the survival motor neuron-2 (SMN2) gene.

Norway-based Targovax ASA has reported promising early data from a trial of its oncolytic virus ONCOS-102, in combination with chemotherapy, in patients with malignant pleural mesothelioma. Malignant mesothelioma is a tumour of the tissue surrounding the lungs, stomach and heart and is caused by exposure to asbestos fibres.

CureVac AG has reported positive Phase 1 data from a trial in healthy volunteers of an experimental rabies vaccine based on messenger RNA (mRNA). The prophylactic vaccine, CV7202, encodes the rabies virus glycoprotein RABV-G in a lipid nanoparticle formulation.

Boehringer Ingelheim GmbH has encountered a setback in its plans to develop multiple products for non-alcoholic steatohepatitis (NASH). A small molecule drug in-licensed from Pharmaxis Ltd in Australia is being dropped from development because of the risk of drug interactions, the German company said on 18 December.

A large observational study of patients with atrial fibrillation treated with the cardiovascular drug Lixiana (edoxaban), has confirmed that the drug is noninferior to warfarin but generates fewer bleeding episodes, according to the developer, Daiichi Sankyo Co Ltd.

A combination therapy directed at patients with advanced non-squamous non-small cell lung cancer, failed to show a clinically meaningful overall response rate in a Phase 2 clinical trial, the developer Transgene SA announced on 12 December. Transgene has stopped further development of the compound TG4010, which is a cancer vaccine based on a modified Vaccinia virus.

The antibody-drug conjugate belantamab mafodotin has generated an overall response rate of 31% in a pivotal Phase 2 study of patients with relapsed/refractory multiple myeloma, GlaxoSmithKline Plc announced on 17 December. The UK company has made a regulatory submission for the drug with the US Food and Drug Administration.