At least BIT got some market exposure from todays announcement - though the 15% SP gain evaporated by the end of trading.
ASX Health Stocks: Biotron jumps 15pc after hitting primary objectives of Phase 2 trial - *ASX Health Stocks: Biotron jumps 15pc after hittingprimary objectives of Phase 2 trial
Biotron jumps after Phase 2 trial success
Biotron (ASX:BIT) jumped +15% this morning after announcing promising results fromits BIT225-011 Phase 2 clinical trial, indicating that the primaryobjectives of the study have been achieved.
This trialfocused on evaluating BIT225, the company’s lead antiviral drug, in combinationwith standard antiretroviral therapy (cART), for HIV-1 infected individuals whohad achieved only partial immune reconstitution.
The trial,involving 20 treatment-experienced participants, assessed BIT225’s safety,tolerability, and its impact on immune activation, inflammation, and viralmarkers over a 12-week period.
Preliminaryanalysis revealed that BIT225 at a daily dose of 200mg was generally safe andwell tolerated, with no drug-related serious adverse events reported.
Althoughone participant withdrew from the study after the initial dose, adverse eventswere mild and consistent with previous trials.
Regardingefficacy, the study observed maintained viral suppression throughout thetreatment period. Significant changes (P<0.05) were noted in immune markerssuch as NK cells and T-regulatory cells, crucial in combating viral infections.
Thesefindings suggest that BIT225, when used alongside cART, may have animmune-modifying effect beneficial to HIV-1 patients who exhibit incompleteimmune recovery post-antiviral therapy.
ProfessorAnthony Kelleher from the Kirby Institute at theUniversity of NSW said the results were very positive and significant, notingthat individuals who do not fully restore their immune function post-antiviraltherapy face increased risks of serious health conditions.
“Theseindividuals are at enhanced risk for serious comorbid conditions includingneurocognitive, cardiovascular, renal and hepatic disorders that impair qualityof life and drive healthcare expenditures.”
While thetrial did not show an increase in CD4 cells, which are critical for immunefunction, the observed changes in immune markers are promising and warrantfurther clinical investigation, says Biotron.
MichelleMiller, Biotron’s CEO, added: “This trialextends our understanding of BIT225 and complements the results from theprevious HIV trials.
“Theresults reported here are preliminary, and ongoing analysis of this BIT225-011trial and the BIT225-010 HIV-1 trial in a treatment-naïve population will bereported when complete.”
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