Clinical Research

Encouraging early data for a new drug in patients with HIV infection has been reported by France-based ABIVAX SA, a publicly listed company with two candidate products in clinical development.

Gilead Sciences Inc has stopped a Phase 2 study of the monocolonal antibody simtuzumab in patients with idiopathic pulmonary fibrosis (IPF) due to lack of efficacy. The decision was based on a recommendation of the study’s data monitoring committee.

Medivir AB has announced the termination of an early-stage hepatitis C project that was being conducted with Janssen Pharmaceuticals because early signs of clinical activity were too weak. The compound, AL-704, was nevertheless safe and well-tolerated.

A candidate gene therapy for haemophilia B developed by scientists at University College London (UCL) was so effective in a Phase 1/2 study that Syncona LLP has decided to start a new company to commercialise it.

Darmstadt, Germany-based Merck KGaA has dropped the candidate oncology drug evofosfamide following two Phase 3 studies that failed to show efficacy in patients with advanced soft tissue sarcoma and advanced pancreatic cancer.

Eli Lilly and Company is discontinuing development of the basal insulin peglispro (BIL), a candidate treatment for Type 1 and Type 2 diabetes, following increases in a key liver enzyme in patients enrolled in Phase 3 trials of the drug.

It is now widely believed that people who are carriers of a gene called apolipoprotein E are at a greater risk of developing Alzheimer’s disease than those who do not. This does not mean that all carriers of the gene will develop the disease. But the risk is there, which is why an increasing number of companies are focusing their attention on this patient population to find out whether a pharmaceutical intervention could make a difference to their lives. 

Spark Therapeutics Inc said it plans to seek marketing approval in the US next year for a gene therapy following a Phase 3 trial in which the experimental treatment helped restore vision to patients with an inherited eye disorder.

An experimental vaccine against the Ebola virus has received further support from the US government enabling the developers to improve their manufacturing and storage capabilities. The vaccine is being developed by Janssen Pharmaceuticals and Bavarian Nordic A/S.

A Phase 3 trial which was testing a new indication for the marketed respiratory medicine Relvar/Breo Ellipta failed to demonstrate that it could improve the survival rate for patients with chronic obstructive pulmonary disease (COPD) and a history of heart disease.