24 September 2020 - - US-based cloud computing company Veeva Systems (NYSE: VEEV) and Israel-based clinical research organisation Bioforum have forged collaboration with Israel-based specialty biopharmaceutical RedHill Biopharma Ltd. (NASDAQ: RDHL) on a global Phase 2/3 clinical study evaluating opaganib (Yeliva, ABC294640), a first-in-class, orally-administered, sphingosine kinase-2 selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia requiring treatment with supplemental oxygen, the companies said.

The opaganib Phase 2/3 study is set to enroll up to 270 patients in up to 40 clinical sites around the world and collect broad and rigorous data in a short amount of time.

To support the study, RedHill has adopted Veeva Vault CDMS, a modern cloud platform for electronic data capture, coding, data cleaning, and reporting.

Vault CDMS provides RedHill with a flexible EDC that simplifies and streamlines processes for building and deploying clinical studies.

Bioforum, a global data-focused contract research organization and a certified Veeva partner, has been selected by RedHill, a long-time client, to implement and configure Vault CDMS for this COVID-19 study.

Vault CDMS enables trial sponsors and their CRO partners to manage studies collaboratively from build through execution. 

Veeva Vault EDC, part of Vault CDMS, provides an intuitive interface for capturing trial data and is designed for flexibility, enabling teams to create study builds faster and make mid-study changes with no downtime.

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 selective inhibitor with anticancer, anti-inflammatory, and anti-viral activities, targeting multiple oncology, viral, inflammatory, and gastrointestinal indications.

By inhibiting SK2, opaganib impacts multiple cellular pathways which are associated with cancer growth, viral replication, and pathological inflammation.

Opaganib received Orphan Drug designation from the US Food and Drug Administration for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

Opaganib is also being evaluated in a global Phase 2/3 study and a US Phase 2 study for the treatment of coronavirus (COVID-19).

Pre-clinical data have demonstrated both anti-inflammatory and anti-viral activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage.

Opaganib demonstrated potent anti-viral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue.

Additionally, pre-clinical in vivo studies2 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

Opaganib was originally developed by US-based Apogee biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors.

Under a compassionate use programme, COVID-19 patients (as classified by the WHO ordinal scale) were treated with opaganib in a hospital in Israel.

Data from the treatment of these first patients with severe COVID-19 with opaganib have recently been published.3 Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital.

All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation, whereas 33% of the matched case-control group required mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

The development of opaganib has been supported by grants and contracts from US federal and state government agencies awarded to Apogee biotechnology Corp., including from the NCI, BARDA, the US Department of Defense, and the FDA Office of Orphan Products Development.

The ongoing studies with opaganib are registered on www.clinicaltrials.gov, a web-based service by the US National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.