Clinical Research

ABX464, a small molecule drug being investigated for ulcerative colitis, generated positive data in patients who completed a second year of treatment, the developer Abivax SA announced on 2 September. The Phase 2a maintenance study showed that 69% of patients were in clinical remission and 94% benefited from a clinical response at the end of the second year. Twenty-two patients were initially enrolled in the study in which ABX464 was administered once daily at a dose of 50 mg.

A Phase 3 trial of Farxiga (dapagliflozin) has shown a reduction in the risk of kidney failure and cardiovascular or renal death in patients with chronic kidney disease, according to the developer AstraZeneca Plc.  The trial results were presented on 30 August at a virtual meeting of the European Society of Cardiology. Farxiga is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which has been approved to treat Type 2 diabetes and heart failure.

A Phase 3 trial of a prospective triple combination therapy for advanced melanoma failed to meet its primary endpoint of progression free survival, Novartis announced on 22 August. The trial was testing the experimental checkpoint antibody spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib), both approved products, in patients with melanoma with a BRAF V600 mutation.

A candidate antibody therapeutic for atopic dermatitis has met its primary endpoint in a Phase 2a study using a novel treatment strategy. The therapy, KY1005, targets the OX40-ligand, a key regulator of the immune system. In the study, the compound showed a clinically meaningful improvement in disease activity compared with placebo, according to the developer Kymab Ltd.

Data from two Phase 3 studies of the antibody therapeutic ofatumumab in relapsing multiple sclerosis have been published in the 6 August 2020 edition of The New England Journal of Medicine, illustrating the drug’s possible role as a first-choice option for patients with the disease, Novartis announced on 5 August. The data compared ofatumumab with teriflunomide (Aubagio), a marketed multiple sclerosis treatment.

Germany-based Medigene AG continued to progress its pipeline of cellular immunotherapies for cancer in the first half year of 2020 with the launch of a Phase 1 trial of a candidate product for patients suffering from relapsed blood cancers.

A Phase 3 trial of the checkpoint inhibitor Tecentriq (atezolizumab), combined with paclitaxel, did not reach statistical significance on its primary endpoint of progression free survival in patients with metastatic triple negative breast cancer, the developer Roche announced on 6 August. This is despite the fact that an earlier study of the same drug showed a benefit.

T-knife GmbH, a new company with technology for humanising T cell receptors derived from transgenic mice, has raised €66 million in a Series A financing round in order to develop therapies to treat solid tumours. Current gene based cell therapies for cancer have been highly successful in treating haematological malignancies. However thus far they have been unable to overcome multiple barriers for the treatment of solid tumours.

H. Lundbeck A/S has stopped a Phase 2 proof of concept study of a small molecule drug for schizophrenia after an interim analysis of the data showed the trial was unlikely to achieve statistical significance on its primary endpoint. The drug Lu AF11167 is an inhibitor of the phosphodiesterase 10A enzyme.

A second rheumatoid arthritis drug has failed to improve the condition of patients with severe Covid-19 associated pneumonia. Actemra (tocilizumab) did not meet its primary endpoint in a Phase 3 trial of hospitalised Covid-19 patients, Roche announced on 29 July. This follows news earlier in the month that a trial of Kevzara (sarilumab), also for hospitalised Covid-19 patients, was stopped early on lack of efficacy and adverse events.