Clinical Research

Merck & Co Inc paused enrolment on 6 December for two Phase 3 trials of its lead investigational treatment for HIV – a little more than two weeks after stopping dosing in a Phase 2 study of an HIV combination therapy. The measures were taken on the recommendation of the trials’ respective data monitoring committees. They affect MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir, a nucleoside reverse transcriptase translocation inhibitor. In both cases, the actions were taken in relation to total lymphocyte and CD4+ T cell counts in patients.

A stem cell-derived therapy has restored the function of pancreatic islet cells in a patient with Type 1 diabetes in what is being described as the first demonstration of a potentially curative treatment for the disease. The therapy is being developed by Vertex Pharmaceuticals Inc on the basis of research conducted by Douglas Melton, a professor at Harvard University and co-director of the Harvard Stem Cell Institute in Cambridge, US.

Vifor Pharma Group has expanded its presence in nephrology with the acquisition of two companies with therapies addressing specific aspects of vascular calcification. The companies are Sanifit Therapeutics SA of Spain and Inositec AG of Switzerland.

Merck & Co Inc and its partner Ridgeback Biotherapeutics LP published new efficacy data for their Covid-19 treatment on 26 November showing that the anti-viral drug reduced the risk of hospitalisation or death by 30%, compared with a placebo, instead of the earlier reported 50%. The updated efficacy figure is based on additional data presented to the US Food and Drug Administration. The FDA’s Antimicrobial Drugs Advisory Committee was scheduled to meet on 30 November to evaluate the latest information.

Daprodustat, a candidate drug for the treatment of anaemia due to chronic kidney disease, has generated positive data in five Phase 3 trials – the first oral inhibitor of an enzyme linked to a protein complex to show efficacy without an increased cardiovascular risk. Data from two of the trials were published in The New England Journal of Medicine on 5 November 2021.

A candidate antiviral for the treatment of Covid-19 has delivered an 89% reduction in the risk of Covid-19 related hospitalisation or death compared with placebo in a Phase 2/3 clinical study, the developer Pfizer Inc, announced on 5 November. On the recommendation of the trial’s independent data monitoring committee, the study was stopped and data will be sent to the US Food and Drug Administration to support an emergency use authorisation.

An experimental breast cancer treatment for patients with estrogen receptor positive and HER2 negative breast cancer has met the primary endpoint in a Phase 3 trial paving the way for regulatory submissions in the US and Europe in 2022, the developers Menarini Group and Radius Health Inc, announced on 20 October.

An antibody combination therapy has shown a statistically significant reduction in severe Covid-19 or death among patients with mild to moderate disease, the developer AstraZeneca Plc reported on 11 October. This follows the successful trial of a small molecule antiviral agent produced by Merck & Co Inc and Ridgeback Biotherapeutics LP for a similar patient population which was announced on 1 October. Using different agents, the two trials both achieved efficacy rates of 50% compared with placebo.

An anti-viral medicine developed jointly by Merck & Co Inc and Ridgeback Biotherapeutics LP, has reduced the risk of hospitalisation or death in patients with Covid-19 by 50% compared with placebo, the two companies announced on 1 October. A Phase 3 trial of the drug, molnupiravir was stopped early and the developers plan to seek an emergency use authorisation from the US Food and Drug Administration in order to get the medicine onto the market quickly. Molnupiravir is a small molecule ribonucleoside analogue that inhibits the replication of the SARS-CoV-2 virus.

A Phase 3 study of Keytruda (pembrolizumab) in Asian patients with advanced hepatocellular carcinoma met is primary endpoint of overall survival, the developer Merck & Co Inc announced on 27 September. Patients in the trial had previously been treated with sorafenib, an approved treatment for kidney and liver cancers. Hepatocellular carcinoma is the most common type of primary liver cancer.