In the quarterly meeting of the General Assembly of PanACEA on 23rd of September an update was given on the progress of the trials and the capacity development plans. The operational teams and study teams are working hard for the final preparations of the BTZ043 trial that will start in November of 2019. This phase 1A/1B trial will assess the safety/tolerability and bactericidal activity of the novel TB drug BTZ043. Preparations for the SUDOCU study are also well under way. This phase IIB trial is scheduled to start in Q2 of 2020 and will assess the optimal dose of sutezolid for larger follow-up studies.
On Tuesday 10th of September the 12th edition of the International Workshop on Pharmacology of Tuberculosis Drugs took place in London. The annual platform brings together experts to share the latest findings in the field of TB clinical pharmacology. From this perspective, Lindsey te Brake presented the PK findings of the PanACEAII HR1 trial. Elin Svensson gave a presentation on exposures, treatment response and biomarkers, also a key theme of the PanACEAII project.
The yearly INTERTB symposium, organised by dr. Amina Jindani, was held in London on Monday 9th of September. Martin Boeree presented the results of the PanACEAII HR1 trial and opened the discussion on the optimal dose of rifampicin. Other speakers were, amongst others, consortium members Patrick Phillips, Timothy McHugh and Gerry Davies.
Celso Khosa is the scientific director of Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC), Instituto Nacional de Saúde Mozambique (INS) since 2018 and he is responsible for the daily activities of PanACEA II in Mozambique.
Dr. Khosa has been a medical doctor and researcher at INS-CISPOC since 2013, leading the TB research program, implementing observational studies and clinical trials in TB therapeutics and diagnostics in adult and paediatric population. He is a last year PhD candidate in Medical Research / International Health at the University of Munich. Dr. Khosa is currently the Principal Investigator in several TB studies, including clinical trials for new drugs in TB and HIV treatment.
His main research interest includes tuberculosis, HIV and Comorbidities associated with HIV.
Dr. Julia Dreisbach, a veterinary doctor, led the preclinical development of BTZ-043 and now acts as clinical project manager in the BTZ-043 Multiple Ascending Dose Study in Patients.
She coordinates in parallel all non-clinical activities like for example long term toxicity studies in animals, cold- and radiolabeled ADME studies in animals and the development of a suitable drug formulation for BTZ-043
Dr Susanne Schultz studied medicine at the University of Hamburg and is a qualified consultant for general medicine and emergency medicine. From 2007 until 2016 she was living and working as a general practitioner in the UK, the Netherlands and Turkey and completed an MSc in Clinical Trial Management at the Beuth Technical University, Berlin. During these years Dr Schultz supported charities in Kenya as a clinician and medical advisor. She joined the University of Munich in 2017 as clinical investigator and clinical trial coordinator, managing a multi-center trial in the Department for General and Family Medicine. In 2018 she took on a position as sponsor medical expert in the Division of Infectious Diseases and Tropical Medicine, where Dr Schultz is currently working several Phase II TB studies within PanACEA and other projects in Africa.
Larissa completed her studies in nutritional science in 2009 and graduated with majors in nutritional medicine. Thereafter, she started her career in the field of clinical trials as a study coordinator for regulated clinical trials in an in-patient clinical setting. After several years she took up a position as a clinical operations manager in a biopharmaceutical start-up company gearing towards the development of immune evasion vaccines and later joined Hipp GmbH & Co. KG as a clinical project manager for the management of clinical studies on infant formulas. During those years she completed several trainings in ICH-GCP, study management and medical writing. In 2018, Larissa joined the Division of Infectious Diseases and Tropical Medicine at the LMU Munich and acts as a clinical project manager for PanACEA TB trials in the office in Munich and in the field.
The first formal meeting of SimpliciTB General Assembly (GA) took place on the 25th of July. We had an excellent representation of the collaborating groups with 20 attendees from 9 countries. The Executive Group (EG) has been established with colleagues from South Africa, Tanzania, and our new partners from Uganda, Mozambique, Malawi and Gabon joining the group. A number of membership proposals were received for the Scientific Advisory Board and the Ethics Advisory Board, up and coming African scientists will form both of these groups. Contractual developments, finance and budgets for the clinical trial were discussed. We are also pleased to inform you that significant progress was made in operationalizing the capacity development and community engagement components of the work.
On the 1st of July the PanACEA General Assembly met by teleconference for its quarterly gathering. The program of the project is progressing as the preparations for the next trials are ongoing and the Operational Teams are meeting on a regular basis. The Expertise Cores are involved as well, rolling out the MBL assay, building infrastructure for data management, training monitors and so forth.
SimpliciTB is a multi-centre phase 3 clinical trial evaluating a new shorter drug regimen (all-oral BPaMZ) in drug susceptible and resistant pulmonary tuberculosis across 4 continents led by TB Alliance. The trial started in 2018 and the European and Developing Countries Clinical Trials Partnership (EDCTP) has recently awarded 12 million euro for the execution of the trial in sub-Saharan Africa. It also includes capacity building funding that will enhance clinical research in these settings. The University of St Andrews will coordinate the grant and lead medical monitoring, and the TB Alliance will work with PanACEA clinical research sites of PanACEA to deliver the trial.
We are excited that a significant component of the grant is dedicated to building clinical trials capacity in PanACEA sites in line with PanACEA’s objective to support the consortium to deliver improved treatments for patients with tuberculosis.