A Phase 3 trial in which a combination of Keytruda (pembrolizumab) and the IDO1 inhibitor epacadostat were being studied in patients with metastatic melanoma has been stopped after failing to show a benefit in progression-free survival, according to Incyte Corp and Merck & Co Inc.
Vobarilizumab, a protein therapeutic that showed efficacy at Phase 2 in rheumatoid arthritis, has failed to meet the primary endpoint of dose response in a separate Phase 2 study of patients with systemic lupus erythematosus.
SafeHeal SAS, a French company with a medical device to help patients recover from bowel surgery, has received €6 million in Series A financing from investors led by Sofinnova Partners. The funds will support a study that is being run to obtain a CE mark in Europe, and commercial development.
The second arm of a Phase 3 study of the checkpoint inhibitor Tecentriq (atezolizumab) in patients with advanced lung cancer has shown a progression free survival (PFS) benefit when combined with chemotherapy, according to the developer Roche.
An experimental drug for Alzheimer’s disease that has failed in successive trials to show efficacy, demonstrated for the first time that it can reduce amyloid beta plaques in the brain at a higher dose. Gantenerumab achieved an effect at dosing of up to 1200 mg.
AstraZeneca Plc said that final data from its Phase 3 MYSTIC trial which is testing a combination immunotherapy for non-small cell lung cancer, are now expected in the second half of the year, rather than in the first half.
Novartis has expanded an alliance with Science 37 Inc of the US to launch up to 10 clinical trials over the next three years that will be conducted at a participant’s home or a physician’s officer rather than at a formal clinical trial site. Science 37 is a mobile technology and clinical trial company.
Verona Pharma Plc has reported positive top-line data from a Phase 2a trial of its inhaled drug for patients with cystic fibrosis, a rare inherited disease that causes impaired lung function and premature death. The data showed an improvement in lung function that was statistically significant.
Novartis has announced a collaboration with Pear Therapeutics Inc to develop digital therapeutics for patients with schizophrenia and multiple sclerosis using mobile and desktop software. The new products would deliver clinically-proven treatments such as cognitive behavioural therapy.
After one volunteer died and four others were seriously injured during a clinical study in France in 2016, the European Medicines Agency revised its rules for first-in-human studies to tighten the requirements for the dosing of experimental drugs in humans. Introducing the changes in 2017, the agency said that clinical trial protocols are now more complex than ever before and sponsors will need to work harder to exercise oversight.