A Phase 2 trial of an experimental treatment for atopic dermatitis, MOR106, which was being jointly developed by Galapagos NV, MorphoSys AG and Novartis Pharma AG, has been stopped for futility, the companies announced on 28 October. An interim analysis showed a low probability of the compound meeting it's primary endpoint, defined as the percentage change in the eczema area and severity index score.
Biogen Inc and Eisai Co Ltd have announced plans to seek US regulatory approval for aducanumab, a candidate treatment for early Alzheimer’s disease, just months after two Phase 3 trials for the drug were stopped for futility. The decision to proceed with registration follows discussions with the Food and Drug Administration about a larger dataset from the Phase 3 studies which showed that the drug worked at a high dose.
Scientists at the Netherlands Cancer Institute have reported positive results from a trial of a new combination therapy that includes an inhibitor of the B-Raf protein and an epidermal growth factor receptor (EGFR) inhibitor in patients with BRAF-mutated metastatic colorectal cancer. The treatment was pioneered by René Bernards and colleagues after they discovered why patients with BRAF-mutated colorectal cancer were insensitive to BRAF inhibition.
Safety concerns once again triggered the stoppage of a late-stage Alzheimer’s disease trial with a BACE inhibitor, a small molecule drug intended to limit amyloid-beta production. Eisai Co Ltd and Biogen Inc announced the discontinuation of two studies with elenbecestat on 13 September following a review by the trials’ data safety monitoring board.
Ilixadencel, an allogeneic cell therapy developed by Immunicum AB of Sweden, has achieved complete tumour responses in five out of 45 evaluable patients with metastatic kidney cancer in a Phase 2 trial, compared with just one out of 25 patients receiving standard-of care sunitinib. Announcing the results on 29 August, the company said the data support its vision of positioning ilixadencel as a “backbone therapy” for modern cancer treatment regimens.
GlaxoSmithKline Plc has reported positive Phase 2 data for an antibody-drug conjugate directed against multiple myeloma and announced plans to make regulatory filings later this year. The drug, belantamab mafodotin, showed a clinically meaningful overall response rate in patients with the disease, GSK announced on 23 August.
DREAMM-2 enrolled 223 patients with relapsed multiple myeloma who had not responded to other treatments such as an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody. The two-arm study met its primary endpoint of overall response.
A proposed treatment for non-small cell lung cancer combining Imfinzi (durvalumab) with tremelimumab failed to improve overall survival in patients with late-stage disease, AstraZeneca reported on 21 August. The combination therapy was being tested against standard-of-care chemotherapy.
A trial of four experimental treatments for Ebola virus infection has been stopped early because two of the drugs were more effective in preventing deaths, than the others. The multi-drug trial is being carried out in the Democratic Republic of Congo where an outbreak of Ebola disease has been declared a public health emergency.
GlaxoSmithKline Plc has shifted three candidate vaccines targeting filoviruses to the US non-profit organisation, the Sabin Vaccine Institute, as it restructurings its portfolio to put a bigger emphasis on oncology, HIV and respiratory diseases. The products are prophylactic vaccines to prevent infection from the Ebola Zaire, Ebola Sudan and Marburg viruses. They entered GSK’s portfolio when the UK company acquired Okairos AG in 2013.
A candidate antibiotic designed to treat patients with serious infections passed the first of two Phase 3 hurdles after patients with acute bacterial skin and skin structure infections responded to treatment. The drug, ceftobiprole medocaril, is being studied in patients with acute bacterial skin and skin structure infections as well as in Staphylococcus aureus bloodstream infections. It is being developed by Basilea Pharmaceutica Ltd of Switzerland.