News

Galapagos NV and Gilead Sciences Inc have announced positive data from two ongoing Phase 3 trials of the Janus kinase-1 (JAK1) inhibitor filgotinib in rheumatoid arthritis (RA). The trials, FINCH 1 and FINCH 3, met the primary and key secondary endpoints with favourable safety data at the 24 week cut-off date.

France-based Genfit SA has raised $135 million in a global share offering that includes a listing on the Nasdaq over-the-counter market in the US. The company’s US listing is in the form of American Depositary Shares (ADSs). The company has been trading on the Euronext exchange in Paris since 2006.

The US Food and Drug Administration has approved a new drug for the treatment of patients with multiple sclerosis (MS) whose disease gradually worsens over time leading to a disruption of brain function through inflammation and tissue loss. The drug, Mayzent (siponimod), is a small molecule indicated for active secondary progressive MS.

A prospective therapy for birch allergy failed to achieve the primary endpoint in a Phase 3 multi-center trial, according to the developer Allergy Therapeutics Plc. The therapy, B301, is a short-course treatment for birch-pollen induced seasonal allergic rhinitis.

It failed to show statistical significance relative to placebo. The safety and tolerability profile of the therapy were positive.

Record sums were invested in biotech companies in 2018 – especially in those at the early stage of development. According to the US industry association BIO, some $12.4 billion in venture capital was raised in the US for biotech, double the amount generated in 2017, while $600 million was raised in Europe.

Celgene Corp has contracted the UK artificial intelligence company Exscientia Ltd to supply drug discovery services over a period of three years in order to identify new candidate molecules for three programmes in the areas of oncology and autoimmunity.

The alliance is one of several for Exscientia which has also secured collaborations with Roche, GlaxoSmithKline Plc, Sanofi SA and Evotec AG. Celgene, which is soon to be taken over by Bristol-Myers Squibb Co, is also an investor in Exscientia.

Pfizer Inc has entered into an option agreement to acquire Vivet Therapeutics SAS, a privately-held French company with a gene therapy for Wilson disease, a rare genetic disorder that prevents the body from regulating copper. The disease can lead to liver and brain damage.

Pfizer will initially take a 15% equity interest in Vivet with an exclusive option to acquire the remaining shares in the future. The exercise of the option is linked to the performance of the therapy in a Phase 1/2 trial.

The US Food and Drug Administration has approved a new device for treating patients with chronic heart failure who are not suited for other interventions such as cardiac resynchronisation therapy. The device is indicated to improve a patient’s ability to perform a six-minute walk and improve his or her quality of life. These are patients who have a marked limitation of physical activity and who remain symptomatic despite receiving optimal medical therapy.

Two Phase 3 trials of an experimental drug for Alzheimer’s disease were stopped for futility by Biogen Inc and Eisai Co Ltd on 21 March. However a day later, Eisai announced the start of a new Phase 3 programme for another Alzheimer’s treatment which is being developing with Biogen. In both cases the drugs are monoclonal antibodies designed to treat patients with mild cognitive impairment due to Alzheimer’s disease. They apparently differ in the way they target amyloid-beta which are protein fragments in the brain, thought to contribute to neurodegeneration.

A new research collaboration which will study the human microbiome as a source for potential cancer therapies is being undertaken by Enterome SA of France and the Dana-Farber Cancer Institute in Boston, US. The partners will explore whether bacteria in the human microbiome generate antigens which are similar to those found on certain tumours. To the extent that there is a molecular similarity, these bacterial antigens could be used for immunotherapies.