Clinical Research

New data have been reported for Jardiance (empagliflozin), a medicine approved to treat Type 2 diabetes in 2014 and subsequently also authorised to treat heart failure. A Phase 3 trial in 6,609 adults with chronic kidney disease has now shown that Jardiance can confer a significant kidney and cardiovascular benefit. When treated with the medicine, the risk of kidney disease progression or cardiovascular death was reduced by 28% compared with a placebo, according to the trial’s sponsors Eli Lilly and Co and Boehringer Ingelheim GmbH.

An experimental therapeutic vaccine for HIV that has been designed for use with other therapies to suppress the virus in the absence of antiretroviral medication has reported positive data from a Phase 1 study. The trial results were published online on 27 October in Nature Medicine. The vaccine’s developer is AELIX Therapeutics SL in Spain which collaborated on the study with Gilead Sciences Inc of the US and the IrsiCaixa AIDS Research Institute in Badalona, Spain.

A study of patients hospitalised for acute heart failure has shown that a strategy involving the rapid up-titration of medications and close follow-up resulted in a significant reduction in all cause death and hospital readmissions. The trial was stopped early for efficacy. The results of the study were published on line in The Lancet on 7 November. Separately, Roche announced that the trial had used one of its diagnostics to identify individuals suspected of having congestive heart failure.

The antibody-drug conjugate Blenrep (belantamab mafodotin), which was given an accelerated approval in the US for multiple myeloma in 2020, has failed to show superiority against a competitor molecule in a follow-up Phase 3 study. Announcing the trial results on 7 November, GSK Plc said the ADC did not meet its primary endpoint of progression-free survival. Blenrep was being tested against pomalidomide in combination with low dose dexamethasone.

Two Phase 3 trials of an experimental antibiotic for uncomplicated urinary tract infections in female adults and adolescents have been stopped early for efficacy, according to the developer GSK Plc. The trials were testing gepotidacin which inhibits bacterial DNA replication and independently binds to two different type 2 topoisomerase enzymes. The trials were halted on the recommendation of the programme’s independent data monitoring committee. GSK said it plans to submit a new drug application for the antibiotic to the US Food and Drug Administration in the first half of 2023.

Immatics NV has raised $110 million in a public share offering to advance development of its T cell receptor T cell therapies for cancer. The financing coincides with the disclosure of interim clinical data for the company’s lead product IMA203 which is being studied in multiple solid cancers.

NMD Pharma A/S, a spin-out from Aarhus University in Denmark, has reported positive top-line data from a Phase 1/2a trial of a small molecule drug for myasthenia gravis, a chronic autoimmune disease. The drug, NMD670, recently received an orphan designation from the US Food and Drug Administration in light of the seriousness of the disease. Myasthenia gravis causes potentially life-threatening muscle weakness due to impaired neuromuscular transmission. NMD670 inhibits the skeletal muscle-specific chloride ion channel CIC-1.

Lecanemab, an antibody therapy targeting amyloid-beta protofibrils in patients with early Alzheimer’s disease, achieved positive results in a Phase 3 study, paving the way for regulatory reviews in the US, EU and Japan, the developer Eisai Inc announced on 28 September. The study, called Clarity AD, met the primary endpoint as well as key secondary targets, confirming that lecanemab’s mechanism of action is able to reduce cognitive clinical decline in Alzheimer's patients. Lecanemab works by binding to soluble amyloid-beta protofibrils.

Genfit SA of France is to acquire a small Swiss company that specialises in liver diseases in order to expand its clinical-stage portfolio for these complex disorders. The purchase of Versantis AG is expected to complete in the fourth quarter and give Genfit control of VS-01, a liposomal-based therapy for acute-on-chronic liver failure (ACLF), a condition for which no drugs have yet been approved. Genfit will also acquire a small molecule asset and a diagnostic.

A Phase 3 trial of a new monoclonal antibody for rheumatoid arthritis has been shown to be at least as effective as Humira (adalimumab) and methotrexate, the current standard of care, potentially increasing the treatment options for patients who haven’t been able to control their disease with methotrexate chemotherapy alone. The experimental drug, olokizumab, targets the interleukin-6 (IL-6) cytokine directly. This distinguishes it from Humira which targets tumour necrosis factor-alpha and three other antibody drugs that target the IL-6 receptor.