TaiMed Biologics announced yesterday (January 7) that its long-acting monoclonal antibody drugs, TMB-365 and TMB-380, have shown significant positive results in a Phase 2a clinical trial for HIV treatment, with a two-month dosing regimen. The trial successfully met all primary clinical endpoints, with no treatment failures reported among the participants who completed the trial.

TaiMed emphasized that while the currently marketed long-acting HIV treatment Cabenuva and other ongoing long-acting HIV treatment projects have observed cases of treatment failure in clinical trials, no such failures were seen with TMB-365/380, which holds significant indicative value.

Furthermore, no grade 3, grade 4, or serious adverse events related to TMB-365 or TMB-380 were observed in this trial, meeting safety standards. The pharmacokinetic characteristics observed in the trial were consistent with those seen in previous clinical studies, with no significant differences and successful achievement of the targets.

TaiMed explained that the aim of this clinical trial was to assess the efficacy, safety, and pharmacokinetic characteristics of the long-acting TMB-365/TMB-380 combination as a complete regimen for HIV maintenance therapy. The study involved 20 HIV-infected individuals who had already suppressed their viral load through first or second-line treatments. These participants switched to the long-acting TMB-365/TMB-380 dual-antibody combination and discontinued other antiviral medications.

TaiMed noted that participants received intravenous drug treatment every eight weeks, with blood tests conducted to monitor viral load and pharmacokinetic information. Three treatment doses were administered in total. After the treatment regimen was completed, participants resumed daily oral antiviral medication and were followed up for four weeks to gather additional data on the dual-antibody combination’s efficacy, safety, and other pharmacokinetic information.

Resource: 中裕愛滋新藥臨床 報捷