Human Trials

Gilead Sciences’ GS-0976 shows positive effect in phase 2 NASH study

Gilead Sciences announced results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH).

Pfizer’s lung cancer drug lorlatinib succeeds in phase 2 trial

Pfizer says that its investigational, next-generation tyrosine kinase inhibitor lorlatinib showed clinically meaningful activity against lung tumors and brain metastases in a phase 2 trial in patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC).

miRagen Therapeutics reports positive clinical data of MRG-106 in patients with mycosis fungoides form of cutaneous T-cell lymphoma

miRagen Therapeutics has announced new interim results from its ongoing phase 1 clinical trial evaluating the safety, efficacy and pharmacokinetics of MRG-106 in patients with the mycosis fungoides (MF) form of cutaneous T-cell lymphoma (CTCL).

Human clinical trial commences for first leprosy vaccine candidate

The Infectious Disease Research Institute (IDRI) and American Leprosy Missions have started a Phase 1 clinical trial in humans for leprosy vaccine candidate, the first vaccine developed specifically for leprosy.

Ardelyx’s phase 3 study of Tenapanor for IBS-C meets primary endpoint

Ardelyx has released positive results from its second Phase 3 study of tenapanor, dubbed T3MPO-2, for irritable bowel syndrome with constipation (IBS-C).

Bayer, Janssen halt phase III ESUS study of anticoagulant medicine Xarelto

Bayer, along with its development partner Janssen Research & Development, has halted the phase III Navigate ESUS study of rivaroxaban (Xarelto), as it demonstrated comparable efficacy between treatment arms.

Anthem, HealthCore, Boehringer initiate pragmatic clinical trial to study people living with COPD in real-world setting

The first patients have now enrolled in AIRWISE, the world’s largest ever pragmatic clinical trial in chronic obstructive pulmonary disease (COPD) to study how commonly prescribed medicines may reduce the occurrence of exacerbations of COPD.

Zika vaccine found safe, promising in first human trial

A DNA-based Zika vaccine, dubbed GLS-5700, developed by a consortium led by Inovio Pharmaceuticals and GeneOne Life Science succeeded in a phase 1 clinical trial by producing anti-Zika response in humans.

Motif Bio’s iclaprim meets primary endpoint in second phase 3 ABSSI trial

UK-based Motif Bio reported that its skin disorder drug iclaprim has succeeded in a second phase 3 trial in patients with acute bacterial skin and skin structure infections (ABSSSI).