Human Trials

Gilead Sciences’ Biktarvy shows high efficacy in HIV-1 study

Gilead Sciences has reported 96-week results from a phase 3, randomized, double-blinded study evaluating the safety and efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults.

Alnylam seeks MHRA approval to start ALN-AAT02 phase 1/2 trial

Alnylam Pharmaceuticals has filed a clinical trial authorization (CTA) application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to start a phase 1/2 trial of ALN-AAT02 for the treatment of alpha-1 antitrypsin (AAT) deficiency-associated liver disease (alpha-1 liver disease).

Inotrem’s nangibotide yields positive results in septic shock phase IIa study

Inotrem said that a phase IIa study demonstrated the safety and tolerability of nangibotide (LR12), its lead product candidate, in the treatment of septic shock patients.

AstraZeneca’s Imfinzi reduces risk of death by 32% in stage III lung cancer

AstraZeneca said that its oncology immunotherapy Imfinzi (durvalumab) has showed a significant improvement in overall survival (OS) in a phase 3 trial in patients with unresectable stage III non-small cell lung cancer (NSCLC).

FDA lifts clinical hold on Sarepta’s DMD micro-dystrophin gene therapy program

Sarepta Therapeutics, a commercial-stage biopharmaceutical company, has announced that the Food and Drug Administration (FDA) has lifted the clinical hold for its Duchenne muscular dystrophy (DMD) micro-dystrophin gene therapy program.

AstraZeneca’s Farxiga succeeds in phase 3 cardiovascular outcomes trial

AstraZeneca’s diabetes drug Farxiga (dapagliflozin) has succeeded in a phase 3 cardiovascular (CV) outcomes trial (CVOT) by delivering a statistically-significant reduction in hospitalization for heart failure or CV death in patients with type-2 diabetes (T2D).

Roche’s Tecentriq plus chemotherapy reduces death risk in lung cancer study

Roche’s Tecentriq (atezolizumab) in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) has reduced the risk of disease worsening or death in people with non-squamous and non-small cell lung cancer (NSCLC) in the Phase III IMpower132 study.

Zealand’s dasiglucagon succeeds in phase 3 trial for severe hypoglycemia

Zealand Pharma, a Copenhagen-based biotechnology company, said that a pivotal phase 3 trial evaluating dasiglucagon in patients with severe hypoglycemia in diabetes has achieved primary and key secondary endpoints.

Actelion’s Opsumit improves pulmonary vascular resistance in trial of portopulmonary hypertension

Actelion Pharmaceuticals has announced the results of the first randomized controlled trial in portopulmonary hypertension (PoPH), which showed Opsumit (macitentan) significantly improved pulmonary vascular resistance (PVR) compared with placebo, meeting the primary endpoint of the study.