October’s top news stories

8th November 2019 (Last Updated November 8th, 2019 14:47)

GSK has initiated the Phase III EAGLE programme of gepotidacin for the treatment of uncomplicated urinary tract infection and urogenital gonorrhoea, and AstraZeneca has reported that a combination of Imfinzi with chemotherapy improved progression-free survival (PFS) in the ongoing Phase III POSEIDON trial in non-small cell lung cancer (NSCLC). Clinicaltrialsarena.comwraps up key headlines from October 2019.

October’s top news stories
GSK’s gepotidacin belongs to a new antibiotics class named triazaacenaphthylene bacterial topoisomerase inhibitors. Credit: GSK.

GSK initiates Phase III programme of gepotidacin antibiotic

GlaxoSmithKline (GSK) initiated the Phase III EAGLE clinical programme of its investigational antibiotic, gepotidacin, for the treatment of uncomplicated urinary tract infection (uUTI, acute cystitis) and urogenital gonorrhoea (GC).

Gepotidacin belongs to the triazaacenaphthylene bacterial topoisomerase inhibitors antibiotic class. The drug specifically acts on the DNA gyrase and topoisomerase IV enzymes involved in bacterial replication.

The Phase III programme of gepotidacin comprises EAGLE-1 and EAGLE-2 trials. Dosing of patients in the programme has already been commenced.


Imfinzi combination improves survival in NSCLC patients

AstraZeneca reported that a combination of its drug Imfinzi (durvalumab) with chemotherapy improved progression-free survival (PFS) in the ongoing Phase III POSEIDON clinical trial involving treatment-naïve patients with stage IV non-small cell lung cancer (NSCLC).

Imfinzi is a human monoclonal antibody designed to inhibit the interaction of PD-L1 with PD-1 and CD80. It has regulatory approval to treat unresectable, stage III NSCLC.

The drug is also indicated in 11 countries for previously treated advanced bladder cancer patients.


Lilly’s pegilodecakin fails in Phase III pancreatic cancer trial

Eli Lilly reported that the Phase III SEQUOIA clinical trial of pegilodecakin failed to meet the primary endpoint of overall survival in patients with metastatic pancreatic cancer.

Pegilodecakin is an immunotherapy designed to induce the body’s response against cancer and boost tumour-attacking T cells.

The global, multi-centre, randomised, Phase III SEQUOIA trial compared pegilodecakin and Folfox combination to Folfox alone in 567 patients who had progressed on or after a first-line gemcitabine-containing regimen.


OPKO Health and Pfizer report positive Phase III data for somatrogon

OPKO Health and Pfizer reported positive results from the Phase III clinical trial of somatrogon compared to Genotropin (somatropin) in children suffering from growth hormone deficiency (GHD).

Somatrogon is an investigational molecule entity. It comprises the natural growth hormone sequence, a C-terminal peptide (CTP) copy from the human chorionic hCG’s beta chain at the N-terminus, and two copies at the C-terminus.

OPKO Health and Pfizer partnered in 2014 to develop and commercialise somatrogon to treat GHD.


Gilead and Glympse partner on biomarker technology use

US antiviral drugmaker Gilead Sciences formed a strategic collaboration with Glympse Bio to explore the use of biomarker technology in nonalcoholic steatohepatitis (NASH) clinical development.

Under the partnership, Glympse Bio’s synthetic biomarkers will be used to determine clinical trial participants’ stage of disease at the first screening.

Responses to study treatment will be identified in Gilead’s NASH clinical development programme.


Themis Bioscience and CEPI trial Lassa fever vaccine

Themis Bioscience and the Coalition for Epidemic Preparedness Innovations (CEPI) commenced a Phase I clinical trial of Lassa fever vaccine candidate, MV-LASV.

MV-LASV is based on Themis’ measles vector platform and findings licensed from Institut Pasteur. It is a live attenuated, recombinant, viral vectored vaccine formulated using the backbone of the measles Schwarz virus strain.

Under a global alliance, CEPI will fund the investigational vaccine’s development up to the Phase II completion. The Phase II trial will assess MV-LASV for its clinical safety and immunological data.


Oracle and Phlexglobal partner on clinical research

Oracle Health Sciences and Trial Master File (TMF) technology provider Phlexglobal collaborated to accelerate the speed and accuracy of regulatory compliance, as well as inspection readiness in clinical trials.

A TMF is a requirement that should be satisfied by all sponsors and contract research organisations (CROs) to assure that the rights, safety and well-being of trial participants are protected.

CROs and sponsors should also check if the trials are being conducted in accordance with good clinical practice (GCP)  principles, and enhance the audit readiness of clinical data.


Novartis-Incyte’s Jakavi yields positive data in GvHD trial

Novartis and Incyte reported positive results from the Phase III REACH2 clinical trial of Jakavi (ruxolitinib) conducted in steroid-refractory acute graft-versus-host disease (GvHD) patients.

Jakavi is an oral, JAK 1 and JAK 2 tyrosine kinases inhibitor. It has US regulatory approval to treat GvHD in patients aged 12 and above, and for polycythemia vera (PV) in adults with an inadequate response or intolerance to hydroxyurea.

Incyte markets the drug in the US, while Novartis licensed the development and commercialisation rights outside the country.


AbbVie’s Rinvoq yields positive data in SELECT-PsA 2 trial

AbbVie reported positive data from the ongoing Phase III SELECT-PsA 2 clinical trial of Rinvoq (upadacitinib) to treat active psoriatic arthritis.

The trial assessed a 15mg and 30mg once-daily dose of Rinvoq in patients who had not experienced adequate response to one or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).

The drug is a selective and reversible inhibitor of JAK that is being developed by AbbVie for the treatment of various immune-mediated diseases.


UCB’s trial of bimekizumab in psoriasis patients meets goals

UCB announced that the Phase III BE VIVID clinical trial of its bimekizumab met all primary and key secondary endpoints in moderate-to-severe chronic plaque psoriasis patients.

Psoriasis is a common inflammatory disease that affects nearly 125 million people globally.

Bimekizumab is an investigational humanised monoclonal IgG1 antibody and selective inhibitor of IL-17A and IL-17F cytokines, which are known to be associated with chronic inflammation and tissue damage.