Clinical Research

Novo Nordisk A/S’s weight loss drug semaglutide (Wegovy) has achieved significant reductions in heart failure-related symptoms in people with heart failure with preserved ejection fraction and obesity in the Phase 3 STEP HFpEF trial. Novo announced the trial results on 25 August. They were simultaneously published in The New England Journal of Medicine. The Phase 3 trial is one of more than 12 studies investigating semaglutide, a glucagon-like peptide-1 receptor agonist, at a dose of 2.4 mg per week.

Merck & Co Inc and its partner Eisai Co Ltd have discontinued a combination study of Keytruda and Lenvima in head and neck squamous cell carcinoma because it failed to show an improvement in overall survival compared with Keytruda and placebo, the companies announced on 25 August. Called LEAP-010, the Phase 3 trial was intended to explore whether the combination could improve treatment options for patients with recurrent head and neck cancer. The study enrolled 511 individuals.

Data from the first-ever efficacy trial of the shingles vaccine Shingrix in China have shown the product to be 100% effective. The trial included nearly 6,000 participants who were randomised to receive Shingrix or a placebo. No cases of shingles were reported amongst those receiving the vaccine compared with 31 cases in the placebo arm, the developer GSK Plc announced on 23 August.

Remibrutinib, a small molecule treatment for chronic spontaneous urticaria (CSU), or hives, has met all primary and secondary endpoints in two Phase 3 studies involving more than 900 patients, Novartis reported on 9 August. A final readout of the trials and regulatory submission are expected in 2024. Remibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor that prevents the release of histamine, a signalling chemical in the immune system that causes itching and swelling on the skin, key features of the disease.

An obesity drug marketed by Novo Nordisk A/S has been shown to reduce the risk of major adverse cardiovascular events in adults who are overweight. The drug, semaglutide (Wegovy), has been approved in both the US and Europe as an adjunct to diet and exercise for the treatment of obesity. Now its effectiveness as a potential agent for lowering cardiovascular risk has been demonstrated for the first time in a clinical trial.

A preclinical study of a candidate drug to treat opioid use disorder has shown an ability to reduce oxycodone intake and quell drug-seeking behaviour in an animal model. The drug, ADX106772, is a metabotropic glutamate 2 (mGlu2) positive allosteric modulator developed by Addex Therapeutics SA of Switzerland.

Bavarian Nordic A/S has discontinued its respiratory syncytial virus vaccine programme for adults 60 years and older after a Phase 3 study failed to show efficacy against lower-respiratory tract disease caused by the virus. The trial enrolled more than 20,000 adults who were randomised 1:1 to receive either a single dose of the vaccine, MVA-BN RSV, or a placebo.

The first clinical results from a microbiome therapy being developed for indolent non-Hodgkin B cell lymphoma were promising, indicating that a therapy based on synthetic peptides can successfully target multiple cancer cells, according to the developer Enterome SA. In a Phase 1/2 clinical study, EO2463, which consists of four synthetic peptides, selectively targeted multiple B cell markers, enabling the destruction of malignant B lymphocytes abundant in the cancer. Non-Hodgkin lymphoma is a slow-growing cancer of the white blood cells.

Donanemab, a monoclonal antibody targeting beta-amyloid in Alzheimer’s disease, significantly slowed cognitive and functional decline in people with early symptomatic disease, the developer Eli Lilly and Co announced on 17 July. The results, from a Phase 3 trial, were disclosed at the 2023 Alzheimer’s Association International Conference and simultaneously published in the Journal of the American Medical Association.

argenx SE has reported that a subcutaneous formulation of its marketed drug Vyvgart achieved a 61% reduction in the risk of relapse in patients with the rare neurological disorder, chronic inflammatory demyelinating polyneuropathy (CIDP) compared with placebo. Data from the registrational ADHERE study were reported on 17 July.