Clinical Research

Spark plans FDA submission

Country
United States

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.

Ebola vaccine receives US support

Country
Denmark

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.

GSK respiratory trial misses endpoint

Country
United Kingdom

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.

Merck, MD Anderson to work on solid tumours

Country
United States

Merck & Co Inc has announced plans to collaborate with the MD Anderson Cancer Center in Texas to investigate combinations of its checkpoint antibody Keytruda (pembrolizumab) with other agents as possible treatments for three solid tumours.

Venetoclax study meets endpoint - Roche

Country
Switzerland

A Phase 2 study of venetoclax, a new drug for chronic lymphocytic leukaemia (CLL), has shown a clinically meaningful reduction in cancer cells in patients with a specific genetic mutation known as the 17p deletion. The patients all had refractory CLL.

Ebola vaccine shown to be effective

Country
United States

Interim results from a Phase 3 trial in Guinea of a candidate vaccine against the Ebola virus have shown the agent to be safe and effective within six to 10 days of vaccination. The trial data were announced by Merck & Co Inc and published online in The Lancet on 31 July.

Novartis spins out assets to Mereo BioPharma

Country
United Kingdom

A new company has been set up in the UK to acquire clinical assets that large pharma companies may not be in a position to develop further. The first programmes acquired by Mereo BioPharma Group Ltd are three mid-stage clinical assets from Novartis.

Alzheimer’s trial fails to meet endpoint

Country
Germany

A second drug being developed by Roche for Alzheimer’s disease has failed an efficacy test – this time in a Phase 2b trial. The drug, sembragiline (RG1577, EVT302), is an inhibitor of an enzyme that contributes to the production of free radicals, which contribute to the disease’s pathology.

Eli Lilly and Immunocore to test combination therapy

Country
United Kingdom

Eli Lilly and Company and Immunocore Ltd have agreed to test two potential combination therapies for the treatment of melanoma that involve Immunocore’s T cell receptor technology together with two of Lilly’s experimental kinase inhibitors.

Allergy Therapeutics outlines plans for US trials

Country
United Kingdom

Allergy Therapeutics Plc has outlined plans for the resumption of US clinical trials of its short-course vaccine against grass allergy, Pollinex Quattro Grass, following the submission of trial protocols to the Food and Drug Administration, and new funding.