SUDOCU headline results presented at CROI

Posted on by admin

On Tuesday 20 February 2023 our PanACEA colleague Dr Norbert Heinrich presented the headline-results from the PanACEA SUDOCU study at the 30th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle – the largest and most important conference on  HIV and related conditions such as tuberculosis. SUDOCU investigated safety and efficacy of varying doses of sutezolid – a compound in development for treatment of drug-resistant tuberculosis and treatment-shortening for drug-sensitive tuberculosis. The study was conducted at four PanACEA sites: National Institute for Medical Research (NIMR-MMRC), Ifakara Health Institute, Kilimanjaro Clinical Research Institute/Ki’bongoto Infectious Disease Hospital (all in Tanzania) and the Aurum Institute (South Africa). The study found that sutezolid added on top of a background regimen (bedaquiline, delamanid, moxifloxacin) was well tolerated over 12 weeks and improved the treatment efficacy modestly. The results will be instrumental for selection of dose in planned up-coming studies including sutezolid and give hope of replacing linezolid to generate a novel regimen with less toxicity but retained efficacy.

Ivan Noreña MD, MSc.

Posted on by admin

Dr. Ivan Noreña is a medical doctor from Colombia specialized in internal medicine and infectious diseases with several years of clinical and teaching experience in his hometown Bogotá.  After he finished his Master of Science in international health in Munich, he joined the division of infectious diseases and tropical medicine of the LMU university hospital in 2021 to work at the SARS-CoV2 research unit. Since 2022, he is working at the tuberculosis treatment and diagnostic development unit as clinical scientist and acting as sponsor medical expert in current PanACEA consortium studies.

PanACEA & SimpliciTB Annual Meeting, Mangochi, Malawi, 20th-22nd September 2022

Posted on by admin

Finally, after 2 years due to COVID-19, the PanACEA and SimpliciTB family were reunited in Malawi, hosted by Dr Marriott Nliwasa, Kamuzu University of Health Sciences at Makokola Retreat, Mangochi.  The hospitality and organisation of all of the teams made it  a very successful and enjoyable meeting.

PanACEA

The first day started with a variety of workshops being held on, Finance (Rutger Spoor), Statistics (Patrick Philips), Microbiology (Tim McHugh) and Pharmacology Adherence Technology (Marion Sumari-de Boer). The Tuesday afternoon, we unofficially started the first part of the General Assembly on the occasion of the 2022 Annual meeting. This part of the meeting was chaired by Marriott Nliwasa and the stage was set for the scientific presentations of all PhD and Master students who receive or have received grants from PanACEA. At the end of the afternoon, we were able to experience 2 presentations of the work packages with an overview of clinical trials HIGHRIF 1, BTZ043 and PHENORIF.

Wednesday 21st September Professor Martin Boeree (Radboudumc) and Dr Marriott Nliwasa (Kamuzu University Health Sciences, Malawi) officially opened the Annual General Meeting and welcomed all the delegates.

Dr Norbert Heinrich and Professor Martin Boeree provided an overview on the status and preparations of clinical trials  SUDOCU and STEP2C.  Next up was a full programme from the  expertise cores – sponsor responsibility & trial management, Drug management, clinical pharmacology and trials design and statistics, microbiology, biomarkers, data management, and genetics all of whom gave a comprehensive update on their progress followed by engaging question and answer sessions.

Rutger Spoor and Iris Spelier provided an update on finance and communications, followed by a discussion on PANACEA 2 Past-Present-Future and Next steps!

The final session on Day 3 focussed on  consortium governance and  was co-chaired by Dr Nyanda Ntinginya (NIMR-Mbeya), Johann De Bruyn (TASK) and Stellah Mpagama (KIDH) discussing the future of PanACEA 3, in particular the North South and South-South roles, support within the consortium and consensus on collaborations for the future.

The final item on Thursday was a very constructive contribution by Norbert Heinrich on:

Kapiri

Malawi (one of poorest countries in the world) also faces some problems such as climate warming and lack of water. In cooperation with locals, trees are being planted to capture a huge amount of carbon dioxide. And since 2019, 4 boreholes have been realized. More information www.kapiri.de

 

SimpliciTB

TB-MBLA training Programme, Sunday 18th – Monday 19th September 2022, Kamuzu University of Health Sciences, Blantyre, Malawi

Trainers from St Andrews, and NIMR-Mbeya conducted Tuberculosis Molecular Bacterial Load Assay (TB-MBLA)  training in Blantyre, Malawi.  Discussing the principle & application to TB treatment response monitoring followed by delivering a hands-on session for the new clinical trial  OptiRiMoxTB sites.

Delegates from the SimpliciTB workshop work with Dr Wilber Sabiiti (University of St Andrews) to learn how to perform the TB MBLA that will be applied to monitor treatment response in the forthcoming OptiRiMoxTB trial.

Tuesday 20th September Community Engagement (CE), Measurement & Evaluation Workshop

Here we built engagement capacity in clinical research, focussing on Good Participatory Practices (GPP) experiences and plans for a youth development programme.  Importantly, we developed indicators for monitoring and evaluation impact of CE.

Thursday 22nd September

Dr Derek Sloan, Professor Stephen Gillespie and Julie Anderson (University of St Andrews) opened the meeting, welcoming international colleagues, reflecting on achievements and future goals. Rutger Spoor (Radboudumc) provided a finance update.

We welcomed Leandra Lombard (TB Alliance, South Africa) who provided a progress update on the SimpliciTB Trial and capacity development at sites.

Professor Timothy McHugh (University College London)  provided  a presentation on “Microbiology – beyond outcome data”.

The goal of Capacity Development is to support local sites to conduct clinical trials, upgrading existing infrastructure and promoting leadership.

  • Dr Wilber Sabiiti and Dr Leticia Muraro Wilber (University College London) updated on Biomarker training and procurement of phase 1 and phase 2 equipment for the new trial sites.
  • Drs Erica Sanga, Christine Laidson (NIMR-Mwanza, Tanzania) and Zani de Wit (UCT-LI, South Africa) summarised the Community Engagement activities, the Youth Health Ambassador Programme and updated delegates on the Monitoring & Evaluation programme.
  • Dr Stella Mpagama and Dr Alphonce Liyoyo (Kibong’oto Infectious Diseases Hospital, Tanzania) introduced and updated on the progress of OptiRiMoxTB a new phase III multi-centre clinical trial, workshop sessions to discuss trial preparation were also held. Tanzania is leading the new trial, with mentorship from University of St Andrews and Radboudumc, strengthening research capacity in Gabon, Malawi & Mozambique.

Dr med vet Andrea Kelly

Posted on by admin

Dr med vet Andrea Kelly is a medical specialist for microbiology, clinical project manager and Principal Clinical research associate at the Division of Infectious Diseases and Tropical Medicine of the LMU Munich. Andrea is part oft he development team managing phase II studies on Sutezolid and Delpazolid

Consecutive to 5 years as a postdocteral fellow in the TUM Institute for Molecular Virology Andrea has been working for almost 20 years in clinical development with PPD. As a principal CRA she was responsible for site management on clinical trials phase II and III for various indications, cancer research, ophtalmology, neurology and autoimmune diseases during start up, maintenance and close out in the DACH region. During that time Andrea attended several audits and inspection by German and Austrian authorities

Johann de Bruyn

Posted on by admin

Johann de Bruyn is the Chief Executive Officer of TASK, a multi-site clinical research institute based in Cape Town, South Africa. He specialises in growth strategies and change management in organisations, and have successfully managed teams across various industries.

Hamza Hbil

Posted on by admin

In 2015 Hamza completed his studies in Accounting at the HAN University in Nijmegen. In 2016 he started working at Konings & Meeuwissen as assistant accountant working mainly for regional clients. At the same time he started his study Post Bachelor AA Accounting at the HAN University in Arnhem.  In 2019 he started working for GX Software as Finance Professional. He managed all the finances and did the payroll for the organisation. In 2022 he started working for Radboudumc as Financial manager for PanACEA II besides Rutger Spoor. Focussing on budgeting, financial reporting and auditing the financial reports from partners.

Dr. Bayode Romeo ADEGBITE

Posted on by admin

Bayode Romeo ADEGBITE is a medical doctor, and researcher at Centre de Recherches Médicales de Lamabaréné (CERMEL), Gabon and partner institution Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Center

Dr. ADEGBITE has been a medical doctor and public health expert   for Benin republic ministry of Health and the Global Fund. He has joined CERMEL as medical researcher. Currently He is leading the TB research program, implementing observational studies and clinical trials in TB therapeutics and diagnostics in adult and paediatric population at CERMEL. Dr. ADEGBITE is currently the Principal Investigator in several infectious disease studies, including clinical trials for new drugs. His main research interest includes tuberculosis, sepsis, antimicrobial resistance and tropical diseases.

Dr. Caryn Upton

Posted on by admin

Caryn Upton is a medical doctor with 5 years’ experience as an investigator in clinical trials at TASK focused on infectious diseases such as TB and COVID-19. She has a special interest in underserviced populations with TB such as those with TB meningitis and is a PhD candidate through Radboud University looking into the CSF penetration of established and novel TB drugs into the CSF. Dr Upton is principal investigator of a few clinical trials, two of which are focused on novel regimens and treatment shortening in patients with drug-resistant TB, and recently a study on BCG (re)vaccination to reduce morbidity due to COVID-19. She is currently the Scientific Officer for TASK and also assists in grant management and collaborations with global sponsors.

STATUS update: SUDOCU completed recruitment!

Posted on by admin

The PanACEA SUDOCU study completed its recruitment: a total of 75 participants were randomized to 5 arms (15 participants each) with a wide range of sutezolid doses (from 0mg to 800mg BID given over three months).

With this open-label, randomized, phase 2B, dose selection study (ClinicalTrials.gov identifier NCT03959566) we aim to describe the safety/tolerability-exposure relationship of sutezolid (and its main metabolite), in combination with standard-dose bedaquiline, delamanid and moxifloxacin.

Participating PanACEA sites were The Aurum Institute for Health Research (Johannesburg, South Africa), Kilimanjaro Clinical Research Institute (Moshi, Arusha, Tanzania), Ifakara Health Institute (Bagamoyo, Tanzania), and National Institute for Medical Research (NIMR – MMRC) (Mbeya, Tanzania).

The current TB drug development pipeline contains only a limited number of novel agents ready for advanced phase 2 testing, and sutezolid (an oxazolidinone) is one of these compounds in the clinical development stage. Sutezolid will most likely have similar or better efficacy as its sister compound linezolid, however is probably much less toxic as indicated by in vitro and early human data. In the SUDOCU study, PanACEA evaluated sutezolid together with a novel backbone, which has the potential to be a universal regimen for drug sensitive and drug resistant TB. PanACEA anticipates that SUDOCU will identify the optimal dose of sutezolid that provides the best efficacy, at acceptable safety, to be used in follow-up large-scale clinical trials.

We are currently, completing follow-up and checking all samples and data collected. In the analysis stage, we will deploy the most innovative and advanced PK-PD methods to describe the exposure-response relationship of sutezolid.

Ideally, we aim to report a target plasma concentration and an optimal dose of sutezolid as soon as possible!

Lisa Epsig

Posted on by admin

Lisa Espig studied health sciences at the Technical University of Munich for her bachelor’s and master’s degrees. Her areas of focus were scientific research methods and ethics. During those years, she gained first practical experience in the field of clinical research by supporting several university hospitals. She worked in the data management of clinical trials and directly in patient contact by collecting neurophysiological data from patients. After her studies, she worked for a global clinical contract research organization (CRO) as a regulatory submissions coordinator. She was responsible for submissions to the regulatory authorities (e.g., PEI, BfArm) and ethics committees. In July 2021, Lisa joined the Division of Infectious Diseases and Tropical Medicine at the LMU Munich as a junior clinical project manager for PanACEA TB trials and other projects in Africa.