September 28, 2023 The 3rd A-TANGO General Assembly sets up the upcoming clinical trial for success Members of the A-TANGO Consortium met online to discuss progress and ways to overcome major challenges in a clinical trial that will test safety of a combinatorial drug therapy in patients with chronic liver disease.

BARCELONA—The 3rd A-TANGO General Assembly took place online on 26 September 2023. The objective of these annual meetings is to share progress made throughout the year among members of the Consortium and create a better understanding of potential risks and limitations of the project. These meetings offer an opportunity to receive feedback from members of the Scientific and Ethical Advisory Board, Data and Safety Monitoring Committee and Impact Board, and make adjustments to ongoing and future activities based on their expert advice.

The Chief Investigator of A-TANGO Rajiv Jalan, Professor of Hepatology at University College London, UK, and Scientific Director at EF CLIF, Spain, welcomed everyone suring the opening of the General Assembly meeting.

Carrie Morgan, Vice-President of Yaqrit Ltd., UK, provided an update on the regulatory aspects of the clinical trial to be launched soon including the set up of clinical sites in the UK where patient recruitment and enrollment will be carried out. Mikhal Kowaski, Technical Director at Hepyx Ltd., UK, provided an overview of the drug and placebo manufacturing and packaging processes, and highlighted how thanks to the reallocation of partners own budget A-TANGO has been able to overcome the delays previously encountered. Cornelius Engelmann, clinical researcher and consultant at Charité–Universitätmedizin Berlin, Germany, reviewed primary and secondary objectives of this phase 2 clinical trial and provided updates on the study protocol. Fausto Andreola, Senior Research Fellow at University College London, UK, presented an update on the preparation of standard operational procedures for the collection, labeling, storage and shipment of biological samples, pharmacokinetics studies, and the validation of biomarkers of cells death, humoral- and cellular-mediated immune response, liver cell regeneration and senescence. In order to reduce biobanking costs associated with the collection and storage of biological samples, amendments to the standard operating procedures were considered without affecting the overall scope of the project.

Next, Carlos de la Peña-Ramirez, Statistician at EF CLIF, presented an update on public deliverables – Data Protection Impact Report, Statistical Analysis Plan, and Data Management Plan, and explained that further amendments to the electronic case report form, Statistical Analysis Plan and Data Management Plan need to be implemented based on the changes in the standard operating procedures. Mikhal Kowaski, explained how Hepyx Ltd. is preparing a commercialization plan and calculating the market potential of G-TAK combinatorial therapy. Karen Galvin, Head of Network Engagment at Crowdhelix, Ireland, provided an overview of the geographical spread of members of the newly created Liver Health Helix – a virtual international community of researchers and innovators that collaborate across disciplines and sectors. Karen presented new features within Crowdhelix that will start rolling out early next year. Nina Donner, Communications Lead at Concentris GmbH, Germany, reviewed progress regarding communications, dissemination and training activities for early career researchers in A-TANGO. Nina highlighted the growth of the A-TANGO community on social media over the last year and presented most poppular Master Classes on the project's YouTube channel. She called for further collaboration among partners and the need to engage further with EASL and ELPA. Arthur Mulle, Project Manager at Concentris GmbH, provided a global overview of progress, deliverables and milestones and explained that as part of the measures to reduce project's costs all future meetings will be held online.

Rajiv Jalan on behalf of Thomas Berg, Head of Division at Leiden University Medical Center, The Netherlands, presented preliminary findings from a study that aims to identify diagnostic and prognostic features of patients with alcohol-related hepatitis that develop ACLF using existing databases and cohorts from the large-scale studies CANONIC, PREDICT and ACLARA sponsored by EF CLIF.

Next, Isabelle Durand-Zaleski, Chief of Health Economics and Health Services Research at Assistance Publique Hôpitaux de Paris, France, engaged and delighted meeting attendees with her Master Class where she shared her views on how health economics can contribute to A-TANGO.

Finally, at the closing session, Rajiv Jalan thanked everyone for being extremely supportive and able to adapt quickly to changing project requirements.

About A-TANGO

The EU-funded A-TANGO project aims to bring a novel treatment (G-TAK) that combines a drug known to targets inflammation (TAK-242) and granulocyte colony-stimulating factor (G-CSF) which improves hepatocyte proliferation. Alongside the identification of novel biomarkers for patient selection and prognosis, G-TAK is expected to improve the clinical outcome of patients with alcoholic liver disease who are at high risk to develop acute-on-chronic liver failure (ACLF). The A-TANGO Consortium will perform a phase IIb randomized controlled trial to evaluate the safety and effectiveness of this novel treatment.

This study received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement no. 945096.