Clinical Research

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.

Sanofi SA announced the discontinuation on 17 August of its breast cancer programme AMEERA which was investigating amcenestrant, an oral estrogen receptor degrader, in several breast cancer indications. The decision follows the failure of a Phase 3 trial of the drug in patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

Verona Pharma Plc has raised $150 million from a public share offering on Nasdaq in order to support development of ensifentrine, its small molecule drug for chronic obstructive pulmonary disease. The UK company recently completed the first of two Phase 3 trials of ensifentrine in preparation for a possible regulatory submission to the US Food and Drug Administration in the first half of 2023.

A Phase 3 trial of canakinumab in patients with non-small cell lung cancer failed to meet its primary endpoint of disease-free survival compared with placebo despite earlier positive signals of the drug’s potential in the disease. The developer, Novartis, announced the results on 15 August. Canakinumab (Ilaris) is an approved treatment for arthritis and periodic fever syndromes and was being studied as an adjuvant treatment in patients with stages 2 to 3A and 3B lung cancer. The Phase 3 trial did not throw up any unexpected safety signals.

The US Food and Drug Administration has extended a clinical hold on a proposed Phase 3 clinical trial of a microbiome-based therapeutic developed by MaaT Pharma SA of France because it requires more information about the composition of the faecal-derived product. MaaT Pharma announced the clinical hold extension on 10 August.

Alnylam Pharmaceuticals Inc has reported positive Phase 3 data for its RNAi therapeutic patisiran which is being developed for ATTR amyloidosis with cardiomyopathy, a disease caused by the build-up of abnormal proteins in tissues of the heart. The therapy works by silencing the transthyretin messenger RNA, thereby inhibiting the synthesis of transthyretin protein. The disease affects the heart’s ability to function properly leading to shortness of breath and an irregular heart beat.

A small molecule drug designed to improve lung function has met the primary and secondary endpoints in a Phase 3 trial of patients with chronic obstructive pulmonary disease (COPD), the developer Verona Pharma Plc announced on 9 August. The drug, ensifentrine, is a dual inhibitor of the enzymes phosphodiesterase 3 and 4, a mode of action that enables it to combine both bronchodilator and anti-inflammatory effects in a single compound.

A Phase 3 trial of a combination therapy intended to improve the standard of care for the most common type of liver cancer failed to meet its dual primary endpoints, Merck & Co Inc and Eisai Co Ltd announced on 3 August. The trial was investigating Keytruda (pembrolizumab) and Lenvima (lenvatinib) as a first-line treatment for patients with unresectable hepatocellular carcinoma versus Lenvima alone. In the trial, there were trends towards an improvement in overall survival and progression-free survival but these trends did not meet statistical significance, the companies said.

A Phase 3 trial of an experimental checkpoint inhibitor for head and neck cancer has been ended for lack of efficacy, the developer Innate Pharma SA of France announced on 1 August. The drug, monalizumab was being studied in combination with cetuximab (Erbitux) versus placebo plus cetuximab in patients with metastatic disease who had previously had chemotherapy and another checkpoint inhibitor. Despite promising signals in an earlier Phase 1b/2 study, the Phase 3 trial did not meet a pre-defined threshold for efficacy.