Monday 9th of December the PanACEA General Assembly (GA) met again for its quarterly assembly to report and discuss the progress of the project.
The first phase of the BTZ043 trial has started at the end of November at UCTLI and TASK Applied Science. Preparations for the SUDOCU and PHENORIF trials are progressing.
Next time, the GA will meet face-to-face at the Annual Meeting in Mbeya, Tanzania on 18th and 19th of February 2020. On this occasion Investigator’s meetings will be held for the BTZ043, SUDOCU and PHENORIF trials. In addition, several of the Expertise Cores are organizing workshops for capacity development purposes. The Cores will present updates about other planned activities at the Annual Meeting.
The new drug substance BTZ043 is being tested on patients for the first time in a Phase II study performed by the PanACEA consortium. The trial is carried out in Cape Town, South Africa at TASK Applied Science Clinical Research Centre and the University of Cape Town Lung Institute (UCTLI).
The study is funded by the German Federal Ministry of Education and Research (BMBF) and the European and Developing Countries Clinical Trials Partnership (EDCTP).
BTZ043 was discovered at the Leibniz Institute for Natural Product Research and Infection Biology – Hans Knöll Institute (Leibniz-HKI) in Jena. Since 2014, the new chemical entity has been developed in a consortium of scientists from the Leibniz-HKI and the Tropical In-stitute at the Hospital of the LMU Munich within the framework of the German Center for Infection Research (DZIF).
“Following the promising results of the Phase I study in Germany, we see a great chance that the good tolerability of BTZ043 will be confirmed in the treatment of tuberculosis patients. We are confident that we will also see good results in the first efficacy data.” Says Professor Michael Hoelscher, who is leading the Phase II study. If BTZ043 proves to be safe and effective in the current study, this would be a major step in the development of a new drug.
LMU press release
Clinical trial registration
We are pleased to announce that our consortium has added to trials two its portfolio. The SUDOCU and PHENORIF trials replace the Q203 study that was initially planned in the Grant Agreement. The trials will take place in South Africa and Tanzania in 2020.
Having established the maximum tolerated dose of rifampicin in the HIGHRIF trial, the purpose of the PHENORIF study is to further investigate the interaction potential of the higher dosages with a so-called metabolic phenotyping design. This method is a new concept in the PanACEA trial portfolio.
The objective of the SUDOCU trial is to identify the optimal dose of sutezolid in order to advance it into the novel STEPIIC design of PanACEA in which several combinations regimens are evaluated.
The PanACEA HIGHRIF trial that started in the first phase of PanACEA has continued in the current programme and has succesfully come to an end. The maximum tolerated dose of rifampicin was identified at 40mg/kg. Martin Boeree recently presented the results at The 50th Union World Conference on Lung Health in Hyderabad, India. The publication will follow soon.
Dr. Francis Mhimbira is an epidemiologist and a senior research scientist at Ifakara Health Institute (IHI, www.ihi.or.tz). He joined IHI since 2012 working with a TB research group conducting TB epidemiological, diagnostic and clinical trials (drugs and vaccines). He has experience in conducting phase II and phase III TB drug clinical trials. He is currently leading the preparation and conduct of PanACEA related studies at Ifakara Health Institute. Dr. Francis has other research interests which include implementation studies on TB case finding and diagnostic studies.
Dr. Francis received his medical degree from University of Dar es Salaam, Tanzania, a Masters’ degree in Epidemiology from University of Melbourne, Australia and a PhD in Epidemiology from University of Basel, Switzerland.
PanACEA has enrolled the first patients in the first cohort of the BTZ043 trial. BTZ043 is a new compound with activity against tuberculosis. The trial is a phase Ib/IIa study to assess the safety and tolerability of BTZ043 and to evaluate bactericidal activity of different doses. The trial takes place at the University of Cape Town Lung Institute (UCTLI) and TASK Applied Science Clinical Research Centre in Cape Town, South Africa. Klinikum der Universität München is the study sponsor.
The quarterly SimpliciTB General Assembly (GA) met by teleconference on the 24th October. Once again there was excellent representation of the collaborating groups with 15 attendees from 7 countries. The Executive Group (EG) have met regularly and gave a report on contractual arrangements, finance, collaborations, and capacity development. There was a further call for membership proposals to join the Scientific Advisory Board, Ethics Advisory Board and Capacity Development Committee. It was agreed to include the addition of 4 trial sites at Wits, Johannesburg. The General Assembly will meet again, face to face in Mbeya, Tanzania in February 2020.
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.