Human Trials

hVIVO signs new contracts with global biopharmaceutical firm

hVIVO, is pioneering a human-based clinical trial platform to accelerate drug and vaccine development in respiratory and infectious diseases, has signed two new contracts with global biopharmaceutical company for two respiratory syncytial virus (RSV) human challenge studies.

Merck’s HIV therapy Delstrigo achieves primary efficacy endpoint in phase 3 study

Merck’s HIV Therapy Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) has achieved primary efficacy endpoint in phase 3 Drive-Shift study, which is assessing switch to Delstrigo from other antiretroviral treatment regimens.

Lilly, Boehringer’s empagliflozin succeeds in phase III type 1 diabetes trial

Eli Lilly and Company (Lilly) and Boehringer Ingelheim said that their SGLT2 inhibitor empagliflozin has met the primary efficacy endpoint of a phase III program in adults with type 1 diabetes.

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).