Clinical Research

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.

UniQure NV has concluded an investigation of a patient who had a preliminary diagnosis of hepatocellular carcinoma (HCC) whilst participating in the gene therapy trial HOPE-B for haemophilia. In a statement issued on 29 March, the company said “it is highly unlikely the HCC was caused by etranacogene dezaparvovec.” The company has shared the data with the US Food and Drug Administration, which put a clinical hold on the trial in December 2020.

The immune checkpoint inhibitor Tecentriq (atezolizumab) met its primary endpoint of disease-free survival in a Phase 3 study in people with early non-small cell lung cancer, Roche announced on 22 March. The interim analysis showed the drug improved outcomes as an adjuvant therapy following surgery and chemotherapy. At the time of the analysis, data on overall survival were immature.

AstraZeneca Plc has issued fresh data from its US Phase 3 trial of a Covid-19 vaccine developed jointly with Oxford University (AZD1222) showing an efficacy rate of 76% against symptomatic disease. The primary efficacy analysis included the accrual of 190 symptomatic cases of Covid-19 from the 32,449 trial participants. This represents an additional 49 cases as compared with an interim analysis of the trial which was published on 22 March and showed an efficacy rate of 79%.

A new radiotherapy for advanced prostate cancer has delivered positive results in a Phase 3 trial when compared with a standard of care for the disease, Novartis announced on 23 March. Lu-PSMA-617 met both primary endpoints of the trial, improving both overall survival and radiographic progression-free survival. The trial enrolled patients whose disease had progressed following prior taxane and androgen receptor-directed therapies.