Clinical Research

AstraZeneca Plc’s Phase 3 trial of the Imfinzi and tremelimumab checkpoint antibodies did not meet the primary endpoint of improving overall survival compared with standard-of-care chemotherapy in previously untreated patients with Stage IV metastatic non-small cell lung cancer, the company announced on 16 November. This follows the failure of the same combination in July 2017 to reach statistical significance in progression-free survival.

AstraZeneca Plc has reported positive outcome data for its licensed diabetes medicine Farxiga (dapagliflozin) showing that the drug significantly reduces the risk of hospitalisation for heart failure or cardiovascular death among patients with Type 2 diabetes. In a Phase 3 trial, the reduction of risk was 17% compared with a placebo.

A prospective treatment for patients with schizophrenia, who have not responded to other drugs, failed to show statistical superiority in a Phase 3 trial compared with conventional therapy, H. Lundbeck A/S announced on 25 October.

AbbVie Inc is to take full control of a joint cystic fibrosis (CF) research and development programme with Galapagos NV with the goal of bringing a triple combination CF therapy to the market. Currently in early clinical development, the programme consists of potentiator and corrector drug molecules that are intended to increase the activity of mutated copies of the cystic fibrosis transmembrane conductance regulator protein that causes the disease.

Positive data from two Phase 2 studies of filgotinib, a Janus kinase 1 inhibitor being developed for several inflammatory conditions, were published online on 22 October 2018 in The Lancet, Gilead Sciences Inc and Galapagos NV announced.

An enzyme therapy developed by Hansa Medical AB has successfully inactivated donor-specific antibodies in patients with kidney disease enabling them to receive kidney transplants. The result comes from follow-up data from two Phase 2 trials of highly sensitised patients who otherwise would not have been eligible for transplantation.

Nightstar Therapeutics Plc has reported positive Phase 1/2 data from a trial of its gene therapy for X-linked retinitis pigmentosa, a rare inherited retinal disorder primarily affecting males. The 18-patient study showed preliminary evidence of improved visual function.

Galapagos NV has raised $300 million in a secondary offering on Nasdaq two days after the Belgian company and its partner Gilead Sciences Inc announced positive Phase 3 results for a new JAK1 inhibitor to treat rheumatoid arthritis.

Nicox has begun a Phase 2 study of a candidate treatment for glaucoma designed to secure a position in global ophthalmology. The treatment, NCX 470, is being tested in patients with open-angle glaucoma, the most common form of glaucoma, accounting for about 90% of all cases.

AstraZeneca Plc has announced that a Phase 3 trial of its proposed antibody treatment for systemic lupus erythematosus (SLE) failed to meet the trial’s primary endpoint of showing a statistically-significant reduction in disease activity as measured at 12 months by a responder index. Called TULIP 1, the trial was a double-blinded, 52-week placebo-controlled study evaluating the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.