Clinical Research

AstraZeneca Plc has announced that a Phase 3 trial of its proposed antibody treatment for systemic lupus erythematosus (SLE) failed to meet the trial’s primary endpoint of showing a statistically-significant reduction in disease activity as measured at 12 months by a responder index. Called TULIP 1, the trial was a double-blinded, 52-week placebo-controlled study evaluating the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.

Pfizer has stopped two clinical studies that were evaluating a proposed antibody treatment for Duchenne muscular dystrophy (DMD) because of lack of efficacy. The first study was a Phase 2 trial testing the treatment for safety and efficacy, while the second was an open-label extension study, the company announced on 30 August.

The glucagon-like peptide-1 (GLP-1) analogue semaglutide has demonstrated an ability to promote weight loss in people without diabetes, in some cases up to 13.8%, when combined with diet and exercise. The data comes from a Phase 2 trial comparing semaglutide with liraglutide, another GLP-1 analogue, and with placebo.

Novartis has reported positive Phase 3 data from a trial investigating a new treatment for breast cancer targeting a protein in the PI3K pathway, a signalling pathway for human cancers. The compound, BYL719 (alpelisib), showed an improvement in progression-free survival.

AstraZeneca Plc’s treatment for chronic obstructive pulmonary disease (COPD), Bevespi Aerosphere, has shown non-inferiority but not superiority, on one respiratory measure in a Phase 3b trial in which it was compared with a similar treatment from GlaxoSmithKline Plc.

On a second respiratory measure, it failed to show non-inferiority.

A new two-drug monthly regimen for the treatment of HIV-1 infected adults has generated positive data in a pivotal Phase 3 study, ViiV Healthcare Ltd announced on 15 August.

The study, ATLAS, met its primary endpoint showing similar efficacy for the once-a-month injectable two-drug treatment compared with a standard of care, daily, oral three-drug regimen.

A Phase 2a study that was evaluating a potential treatment for paediatric patients with non-alcoholic fatty liver disease was stopped early in August after the first three patients showed an increase in liver fat and elevations in serum alanine transaminase (ALT) levels, raising concerns about liver toxicity.

A study published in the journal Clinical Cancer Research concludes that elevated levels of kidney injury molecule-1 (KIM-1), a transmembrane protein in blood plasma, can predict renal cell carcinoma (RCC) incidence up to five years before a diagnosis.

An early warning of kidney cancer could make the difference between life and death. When diagnosed early, eight out of 10 people will survive for five years or more. But if the disease is diagnosed late, only one out of 10 survive, according to the charity Cancer Research UK.

Oxford BioMedica Plc has teamed up with two UK partners to produce a gene therapy for cystic fibrosis that could be administered to patients through repeat dosing. Boehringer Ingelheim GmbH has an option to commercialise the product.

The small molecule drug, laquinimod, has failed to meet the primary endpoint in a Phase 2 study of patients with Huntington’s disease, a rare neurodegenerative disease. In May 2017 the same drug failed a Phase 3 trial in multiple sclerosis.

The drug is being developed by Teva Pharmaceutical Industries Ltd under licence from Active Biotech AB of Sweden. It is an immunomodulatory therapy that aims to prevent neurodegeneration and inflammation in the central nervous system.