Human Trials

Merck initiates phase 3 programme for evobrutinib in relapsing multiple sclerosis

Merck announced the initiation of two global pivotal Phase III trials (EVOLUTION RMS 1 and 2) studying the efficacy and safety of evobrutinib, an oral, highly selective Bruton’s Tyrosine Kinase (BTK) inhibitor in adult patients with relapsing multiple sclerosis (RMS).

Esketamine nasal spray reduces depressive symptoms in two phase 3 studies

Janssen Pharmaceutical said that the esketamine nasal spray along with the comprehensive standard of care (SOC) has met the primary efficacy endpoints of two phase 3 trials featuring adult patients with a major depressive disorder.

AstraZeneca’s Imfinzi significantly improves OS in phase III SCLC trial

AstraZeneca announced that its Imfinzi (durvalumab) has significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC) in the phase III Caspian study.

Entresto improved measures of heart structure and function in HFrEF patients in new Novartis study

Novartis announced today results from two new clinical trials evaluating improvement in heart structure and function and long-term safety of Entresto (sacubitril/valsartan) in patients with heart failure with reduced ejection fraction (HFrEF).

VALBIOTIS announces additional positive results from phase IIA clinical study of VALEDIA

VALBIOTIS has announced additional positive results from its Phase IIA clinical study of VALEDIA on four parameters which were among the secondary endpoints of the study: blood triglyceride levels, Fatty Liver Index, (fat accumulation in the liver), blood LDL cholesterol levels, and arterial hypertension.

Roche’s one-dose Xofluza meets primary endpoint in phase III flu study of children

Roche’s one-dose Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III MINISTONE-2 study of children with flu.

Novartis’ ofatumumab meets primary endpoints in two phase 3 RMS trials

Novartis said that its human anti-CD20 monoclonal antibody ofatumumab (OMB157) showed superiority over Aubagio (teriflunomide) in two phase 3 trials in patients with relapsing forms of multiple sclerosis (RMS).

AstraZeneca’s anifrolumab meets primary endpoint in phase III SLE trial

AstraZeneca’s new medicine anifrolumab has achieved primary endpoint in the phase III Tulip 2 trial of systemic lupus erythematosus (SLE).

VenatoRx initiates enrollment in phase 3 trial of cefepime/VNRX-5133 in cUTIs

VenatoRx Pharmaceuticals today announced that it has initiated enrollment in its Phase 3 trial of cefepime/VNRX-5133 in patients with complicated urinary tract infections (cUTIs).