TB Alliance’s Community Engagement (CE) forums provide an opportunity for capacity building and for members of TB-affected communities to share experiences for regional engagement in clinical trial research and drug development. On August 12, participants convened virtually to hear updates on TB Alliance’s clinical programs and to learn from researchers and Community Advisory Board (CAB) members.
The webinar was hosted by TB Alliance and featured speakers including: Ezio Távora, member of the Brazilian Tuberculosis Research Network (REDE-TB) CAB; Dr. Folu Olugbosi, Senior Director of Clinical Development at TB Alliance; Oxana Rucsineanu, member of the STREAM CAB in Moldova; Aastha Gupta, Senior Manager of Market Access at TB Alliance; Naoko Doi, Director of Market Access at TB Alliance; and Louie Zepeda-Teng, President of TB People in the Philippines.
The speakers discussed experiences and updates both in research and in engagement initiatives with stakeholders, patients, advocates and other community representatives. A central focus of the discussion was top-line results of the ZeNix clinical trial, which were recently presented at IAS2021.
In his opening remarks, Ezio Távora summarized the importance of CE programs and CABs as a fundamental part of late-stage research and clinical trials for tuberculosis (TB) drugs. “The main objective is to build capacity for country-level CABs and communities to participate in research and development and advocacy around study results,” said Távora.
This introduction on CE led into a presentation of primary endpoint results of the ZeNix Phase 3 clinical trial from Dr. Olugbosi who noted, “The aim of ZeNix is to optimize the linezolid dose and duration with the hope of reducing the side effects and maintaining a similar efficacy as Nix-TB.” The ZeNix clinical trial was conducted in South Africa, Georgia, Russia and Moldova and the primary efficacy analysis results showed that “the approximately 90 percent efficacy from Nix-TB was replicated and, again, this was across a wider geographic area which is quite encouraging,” said Dr. Olugbosi.
The next speaker, Oxana Rucsineanu discussed the practical integration of CE as a pillar of clinical trial design. ZeNix is one of “the first trials ever that has put a big focus on engaging communities in our country,” said Rucsineanu. Some key principles of a CE strategy in research and development demonstrate that it’s “good for the country to have the Community Advisory Board, to have very clear and achievable goals, to develop cultural confidence to put a focus and transparency to make the research processes … as transparent as possible,” she explained.
After a question-and-answer session, Aastha Gupta provided an update on access of the treatment regimen studied in Nix-TB and ZeNix. “Access to the regimens we develop is coded into our mission,” said Gupta, “and we call it the ‘AAA Mandate.’ We are committed to developing regimens that are, by design, amendable to being adopted, available, and affordable – and we work with partners to ensure that happens.” Gupta continued to describe that TB Alliance has collaborated with many different manufacturing and commercialization partners to “ensure widespread availability.” These partners include Viatris (formerly Mylan), Macleods Pharmaceuticals and Hongqi Pharmaceuticals. “In the last 18 months, Viatris has obtained 12 regulatory approvals … while 14 countries are implementing [the regimen] under research conditions.”
To further detail the access strategy for the regimen and civil society engagement, Naoko Doi and Louie Zependa-Teng provided an overview of a country-level initiative happening in the Philippines. Doi noted that the initiative aims “to promote TB treatment literacy and to raise awareness of the new treatment options that have become available among TB survivors and advocates, and other affected communities so that they can use the information to empower their peers, other people with TB, their family and other affected communities who may be at a higher risk of infection.”
Louie Zepeda-Teng is a TB survivor and the current president of TB People in the Philippines. As the final speaker during the CE Forum, she described the program further and said that this is “the first time that the community will be involved in the creation of materials for advocates to use.” Zepeda-Teng continued and said that “this project might actually create the impact on dealing with advocacy for finding the 2.5 million missing Filipinos with tuberculosis.”