Clinical Research

Three Phase 3 studies in pregnant women of a candidate vaccine designed to prevent infection from the respiratory syncytial virus (RSV) have been stopped following a safety signal. The developer, GlaxoSmithKline Plc, announced a pause in the studies on 18 February and a halt 10 days later. The decision was based on an observation from the study’s independent data monitoring committee during a routine safety assessment. The safety observation wasn’t disclosed. Altogether, the three studies were scheduled to enrol 21,462 individuals, according to clinicaltrials.com.

A Phase 3 trial of Dupixent (dupilumab) in patients with chronic spontaneous urticaria has failed to meet its primary endpoints and is being stopped early, Sanofi SA announced on 18 February. Dupixent is a widely prescribed medicine for asthma and atopic dermatitis and is being investigated for a possible new indication in urticaria, a chronic inflammatory skin disease characterised by the sudden onset of hives.

Bayer AG has decided to discontinue development of the Phase 2 drug candidate, eliapixant, a P2X3 receptor antagonist that was being evaluated in endometriosis, refractory chronic cough, overactive bladder and diabetic neuropathic pain.

This is based on a review of data showing that the overall benefit no longer outweighs the risk in these indications. The drug was developed in collaboration with Evotec SE which will regain rights to the assets. Bayer announced its decision on 4 February 2022.

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Pfizer Inc and Valneva SE have reported further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. As a result, the companies plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 trial. The trial is expected to start in 2022.

Pharming Group NV of the Netherlands has achieve positive results from a Phase 2/3 registration-enabling study of the small molecule drug leniolisib, a candidate treatment for activated phosphoinositide 3-kinase delta (PI3K delta) syndrome, an ultra-rare primary immunodeficiency disease. The placebo-controlled study consisted of two sequential parts, the first of which was a successful dose escalation study which reported results in 2018. Results from the second part of the study, reported on 2 February, showed clinical efficacy, including a normalisation of immune dysfunction.

Pfizer Inc and Ionis Pharmaceuticals Inc have discontinued development of vupanorsen, an antisense oligonucleotide intended for cardiovascular risk reduction and the treatment of severe hypertriglyceridaemia, a condition characterised by high amounts of triglycerides in the blood. Announced on 31 January, the decision was taken despite favourable results from a recent Phase 2b study.

Data from four Phase 3 trials of faricimab, an experimental bispecific antibody for two eye diseases, were published online in The Lancet on 24 January, showing that the treatment delivered vision gains for patients that were at least as good as those achieved for aflibercept (Eylea), a widely prescribed ocular treatment. At the same time, faricimab required less frequent injections, according to the studies. Two of the trials enrolled patients with wet age-related macular degeneration and two enrolled patients with diabetic macular oedema.

The checkpoint inhibitor Imfinzi (durvalumab), in combination with chemotherapy, reduced the risk of death by 20% in a Phase 3 trial of patients with advanced biliary tract cancer, the developer AstraZeneca Plc announced on 18 January. The multicentre trial compared Imfinzi and chemotherapy, with chemotherapy alone as a first-line treatment. Called TOPAZ-1, the trial enrolled 685 patients with unresectable cancer, including gallbladder cancer.

Asian patients with advanced hepatocellular carcinoma were able to live longer after being treated with Keytruda (pembrolizumab), one of the most widely prescribed checkpoint inhibitors for cancer. A Phase 3 trial of 453 patients with the disease achieved an overall survival rate of 21%, potentially acting as a confirmatory study for an accelerated approval given to Keytruda for this indication in the US, the developer Merck & Co Inc announced on 18 January.

ReNeuron Group Plc has taken a decision to out-license a clinical-stage cell therapy programme for retinitis pigmentosa (RP), an eye disease in which the retina is damaged, and focus instead on developing its exosome technology. The decision was announced to the London Stock Exchange on 18 January.