Human Trials

Silence seeks UK MHRA approval to launch first-in-human study of SLN124

Silence Therapeutics has filed a clinical trial application (CTA) with the UK Medicines and Healthcare products Regulatory Agency (MHRA), seeking approval to launch a phase Ib trial for the investigational drug, SLN124.

Evgen’s SFX-01 meets goals in phase 2 metastatic breast cancer trial

UK-based clinical-stage company Evgen Pharma reported that its phase 2 STEM trial evaluating SFX-01 for the treatment of metastatic breast cancer has met its primary endpoints.

Aimmune’s peanut allergy candidate AR101 succeeds in phase 3 European trial

Aimmune Therapeutics said that a phase 3 trial held in Europe that evaluated its lead candidate AR101 for the treatment of peanut allergy, met its primary efficacy endpoint.

Conatus announces top-line results from ENCORE-NF phase 2b clinical trial in NASH fibrosis

Conatus Pharmaceuticals has announced top-line results from the company’s Phase 2b ENCORE-NF clinical trial in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and liver fibrosis.

GSK’s anti-BCMA antibody-drug conjugate improves ORR in cancer study

GlaxoSmithKline (GSK) announced that 60% of patients with relapsed / refractory multiple myeloma securing GSK2857916 anti-B-cell maturation antigen (BCMA) antibody-drug conjugate achieved an overall response rate (ORR) in DREAMM-1 study.

Merck KGaA, Pfizer discontinue phase III JAVELIN ovarian PARP 100 trial

Merck KGaA and Pfizer have announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study evaluating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (stage III or stage IV).

Study finds widely used heart drug increases risk of sudden cardiac arrest

A recently conducted study found that a commonly used drug for high blood pressure and angina (chest pain) is associated with increased risk of sudden cardiac arrest.

Xeris Pharmaceuticals doses first patient in phase 2 trial to assess ready-to-use glucagon

Xeris Pharmaceuticals has now begun dosing patients in a phase 2 trial with its ready-to-use, room-temperature stable liquid glucagon in patients with Type 1 diabetes who experience episodes of exercise-induced hypoglycemia (EIH).

Esperion unveils positive human trial results for new cholesterol-lowering drug

Esperion Therapeutics said the phase 3 long-term safety study showed that bempedoic acid has significantly reduced low-density lipoprotein cholesterol (LDL-C), as well as high-sensitivity C-reactive protein (hsCRP).