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ABX203 bust?
ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), an innovative company developing anti-viral therapies and immunotherapeutics for infectious diseases like HIV/AIDS, chronic hepatitis B (CHB), chikungunya, ebola as well as an adjuvant to enhance the immune response, today announced that a futility analysis on the primary end-point of its ABX203-002 trial, a Phase IIb/III trial of ABX203 in CHB patients, determined that the trial is unlikely to reach its primary endpoint.
The ABX203-002 study is an open-label, randomized, comparative study designed to assess the efficacy of ABX203 to maintain control of the hepatitis B virus after cessation of nucleotide analogs (NUCs), in particular in controlling viral load for a much longer period of time when compared to current treatment options. This study is ongoing in seven Asian/Pacific countries (Taiwan, Hong-Kong, Thailand, Singapore, South Korea, Australia and New-Zealand). In this large scale controlled and randomized study, where 276 subjects were enrolled as of September 2015, one group of patients received ABX203 for 24 weeks, in addition to the current standard of care (nucleoside analogues, NUCs). All therapy was stopped after 24 weeks, and these patients are evaluated against a control group receiving NUCs only. The study’s primary efficacy endpoint is the percentage of subjects with viral load <40 IU/mL at week 48, i.e 24 weeks after the treatment with ABX203 has been completed.
An unscheduled futility analysis was initiated because of a recent increase in the patients’ drop out rate related to viral escape. A futility analysis is conducted during an ongoing clinical trial to describe the probability of a study to reach its primary endpoint. The result of this analysis shows that a positive outcome of the study regarding its primary endpoint is unlikely.
The Data Safety and Monitoring Board (DSMB) of study ABX203-002 was convened. The DSMB has recognized the good safety profile of ABX203 and recommended that the study should continue as per protocol, to monitor patients 24 weeks post-treatment in order to continue to assess their viral load and to have a comprehensive view of the secondary endpoints. Investigators, health authorities and patients are being informed of the conclusions of the DSMB.
In a previous Phase II study, with a different design and carried out in Asia, treatment-naïve patients with chronic hepatitis B were administered ABX203 as monotherapy. That study established a significantly longer period to viral rebound as compared to patients receiving Peg-Interferon Alpha.
The future development of ABX203 is under review, including the usefulness of an adjuvant boosting the response to this immunotherapy, as well as new administration schedules and therapeutic combinations that may be evaluated via other preclinical and, potentially, clinical testing.
The ABX203-002 study is an open-label, randomized, comparative study designed to assess the efficacy of ABX203 to maintain control of the hepatitis B virus after cessation of nucleotide analogs (NUCs), in particular in controlling viral load for a much longer period of time when compared to current treatment options. This study is ongoing in seven Asian/Pacific countries (Taiwan, Hong-Kong, Thailand, Singapore, South Korea, Australia and New-Zealand). In this large scale controlled and randomized study, where 276 subjects were enrolled as of September 2015, one group of patients received ABX203 for 24 weeks, in addition to the current standard of care (nucleoside analogues, NUCs). All therapy was stopped after 24 weeks, and these patients are evaluated against a control group receiving NUCs only. The study’s primary efficacy endpoint is the percentage of subjects with viral load <40 IU/mL at week 48, i.e 24 weeks after the treatment with ABX203 has been completed.
An unscheduled futility analysis was initiated because of a recent increase in the patients’ drop out rate related to viral escape. A futility analysis is conducted during an ongoing clinical trial to describe the probability of a study to reach its primary endpoint. The result of this analysis shows that a positive outcome of the study regarding its primary endpoint is unlikely.
The Data Safety and Monitoring Board (DSMB) of study ABX203-002 was convened. The DSMB has recognized the good safety profile of ABX203 and recommended that the study should continue as per protocol, to monitor patients 24 weeks post-treatment in order to continue to assess their viral load and to have a comprehensive view of the secondary endpoints. Investigators, health authorities and patients are being informed of the conclusions of the DSMB.
In a previous Phase II study, with a different design and carried out in Asia, treatment-naïve patients with chronic hepatitis B were administered ABX203 as monotherapy. That study established a significantly longer period to viral rebound as compared to patients receiving Peg-Interferon Alpha.
The future development of ABX203 is under review, including the usefulness of an adjuvant boosting the response to this immunotherapy, as well as new administration schedules and therapeutic combinations that may be evaluated via other preclinical and, potentially, clinical testing.
So they took patients who were on nucs, stopped nucs and started abx203 ? How about treatment naive patients, any clinical trial ?
2 Comments
No, they took patients that were on nucs and then added the vaccine shots for 24 weeks on half of them, continuIng nucs, then stopping all treatment for both groups and observing the resurgence of hbv dna. The hope was that the vaccine shots will keep the hbv dna suppressed in a large or significantly larger percentage of the vaccine add on group at the 24 week mark after EOT. Now they see that this endpoint will not be met.
The Bangladesh trial used treatment naive patients, about 160, and treatment was vaccine only or pegasys. It was not reported in the available abstract how many were eag pos or neg. I would assume it was a mix.
The e ag pos have a much better chance for a stabilizing response.
The e ag pos have a much better chance for a stabilizing response.
According to the clinical trial information, all enrolled patients are HBeAg negative. The conference call was not available in Australia. From their Bangladesh trial that showed ABX203 was more potent than Interferon, they must have hoped that ABX203 will be effective in combination with NUCs in virally suppressed patients. Still with no details of any immunological data from the Bangladesh trial, it is hard to tell what ABX203 can or cannot achieve. Hopefully, there will be more data from this trial, and also from patients in Cuba who may be using this vaccine.
Hope it'll get soon a final FDA approval & hit z market. we appreciate as always Studyforhope.
Very frustrating!
1 Comments
The way this trial was designed, it is not at all surprising that many patients lost control over their viral load after they stopped antivirals, even after the multiple cuban vaccine shots. It is just not as powerful and the expectations were naive. This does not mean that the combo surface-core particle vaccine is not a useful add on in several possible combo schemes. So dont loose hope.
It is disappointing. Hopefully, we can learn more about the activities of ABX203 from the trials.
1 Comments
The info given in this investment type report is very limited. they dont even say if the patients were e Ag pos or neg. I read there is a conference call available re this. Did you have time to listen to this and gain more info?
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