Human Trials

Vertex launches phase 3 trials of VX-445/Tezacaftor/Ivacaftor combo in cystic fibrosis

Vertex Pharmaceuticals has initiated two phase 3 studies of VX-445, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF).

Helperby Therapeutics’ combination antibiotic therapy is effective against WHO critical priority pathogen in phase 1 study

Helperby Therapeutics has announced Phase I results on the tolerability, pharmacokinetics, pharmacodynamics and efficacy of AZT and colistin both alone and as a combined therapy, against multi-drug resistant Enterobacteriaceae (CRE), one of the most serious drug resistant pathogens.

Boehringer Ingelheim, Lilly, University of Oxford to study empagliflozin in chronic kidney disease

Boehringer Ingelheim and Eli Lilly and Company have entered into an academic collaboration with the University of Oxford to assess the effects of Jardiance (empagliflozin) on heart and kidney disease in adults with chronic kidney disease.

Merck’s Keytruda significantly decreases risk of disease recurrence in melanoma study

Merck has reported results from the Phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma.

AstraZeneca’s Tagrisso shows sustained PFS in phase 3 lung cancer trial

AstraZeneca said that Tagrisso (osimertinib) in a first line setting has shown significant progression-free survival (PFS) benefit that was preserved through subsequent lines of therapy in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

Personalized tumor vaccine yields promising results in pilot trial

A new type of cancer vaccine has shown promise in an initial clinical trial conducted at the Perelman School of Medicine at the University of Pennsylvania and the Abramson Cancer Center of the University of Pennsylvania.

Incyte and Merck’s melanoma combo therapy fails in phase 3 trial

A phase 3 study of Incyte’s epacadostat in combination with Merck’s Keytruda (pembrolizumab) in patients with unresectable or metastatic melanoma has failed meet to primary endpoint.

MyoKardia begins dosing in phase 2 HCM trial of Mavacamten

MyoKardia has started dosing in its phase 2 MAVERICK-HCM clinical trial of mavacamten, the company’s oral, allosteric modulator of cardiac myosin mavacamten candidate in symptomatic non-obstructive hypertrophic cardiomyopathy patients.

Sellas’ NeuVax + Herceptin combination treatment shows significant effect in breast cancer trial

Sellas Life Sciences Group has reported a positive interim data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of trastuzumab (Herceptin) +/- nelipepimut-S (NeuVax™) in HER2 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences.