Clinical Research

Sanofi SA has stopped a clinical programme in autosomal dominant polycystic kidney disease after its small molecule drug venglustat failed to show a meaningful reduction in the total kidney volume growth rate. The programme was halted during the first stage of a pivotal Phase 2/3 study. Venglustat was targeting glycosphingolipids (GSL), which modulate membrane-to-protein functions and contribute to cell-to-cell communication.

Novartis has stopped a Phase 3 study of its eye treatment Beovu (brolucizumab) early following incidents of intraocular inflammation including retinal vasculitis and retinal vascular occlusion. Called MERLIN, the study was evaluating Beovu in a new four-week dosing regimen for patients with wet age-related macular degeneration (AMD). The drug has already been approved in the US and elsewhere, but at a longer dosing interval.

Abivax SA has reported efficacy in a Phase 2b trial of a small molecule treatment for ulcerative colitis, paving the way for the start of a Phase 3 programme by the end of the year. Patients in the placebo-controlled trial had moderate to severe colitis and included individuals refractory to conventional drugs including biologics and/or JAK inhibitors. Significantly, the lowest dose of 25 mg was effective across the entire study population, the company announced on 24 May.

The French vaccine company Valneva SE has raised $107.6 million from an initial public offering of shares on the US Nasdaq market, enabling it to accelerate development of candidate vaccines to prevent Covid-19 as well as Lyme disease. The company also has a prophylactic vaccine in development against the chikungunya virus, which is prevalent in Africa, Asia and India. The company’s American Depositary Shares began trading on Nasdaq on 6 May.

Valneva is also listed on Euronext Paris.

Technology that integrates clinical trial data from patients with dementia and machine learning has received financial support from public and private funders in the UK. The company responsible for the technology is Cumulus Neuroscience Ltd (formerly BrainWaveBank) of Belfast, Northern Ireland. On 4 May, it announced receipt of £6 million from the Dementia Discovery Fund, the Future Fund and the charity, LifeArc.

An experimental long-acting antibody has reduced infections caused by the respiratory syncytial virus (RSV) in a Phase 3 trial of healthy infants. Nirsevimab met its primary endpoint of significantly reducing the incidence of lower respiratory tract infections, the developers AstraZeneca Plc and Sanofi SA announced on 26 April.

Bimekizumab, a monoclonal antibody directed against interleukin-17A and interleukin-17F, has outperformed two marketed products in separate Phase 3 trials of patients with moderate-to-severe plaque psoriasis, a chronic inflammatory skin disease for which there is no cure.

The trial results were published in separate articles in The New England Journal of Medicine on 23 April 2021.

A candidate vaccine for the prevention of malaria has shown an efficacy rate of 77% in a Phase 2b trial of African children between the ages of five to 17 months – exceeding an efficacy target set by the World Health Organization. The trial results were published online by The Lancet on 22 April 2021, prior to peer review.

Merck & Co Inc is to discontinue development of a recombinant fusion protein for Covid-19 because additional studies would be needed to qualify it for an emergency use authorisation. Merck announced the decision on 15 April following feedback from the US Food and Drug Administration. 

GlaxoSmithKline Plc has stopped two Phase 2 studies of the IgG4 monoclonal antibody feladilimab that was being investigated in patients with metastatic head and neck squamous cell carcinoma. The company announced the discontinuation of the INDUCE-3 and INDUCE-4 trials on 14 April. This follows a recommendation by one of the trial’s independent data monitoring committees. The reasons were not given.