Taipei, Taiwan –TaiMed Biologics today announced that the USA FDA did not raise any concern within the mandatory 30 calendar days review period for the clinical study protocol application of combination therapy using two monoclonal antibodies (TMB-365/380).

The Phase IIb trial is designed to evaluate the efficacy and safety of intravenous administration of TMB-365 and TMB-380 every eight weeks as a long-acting maintenance therapy for virally suppressed HIV-1 patients over a 48-week period. Compared to the earlier Phase IIa study, the new trial significantly expands in scope—increasing patient enrollment from 21 to 75, doubling the treatment duration from 24 to 48 weeks, and, for the first time, including Taiwan as trial site.

The trial’s primary endpoint is the proportion of participants maintaining plasma HIV-1 RNA levels below 50 copies/mL at Week 48, assessed via the FDA Snapshot algorithm. Secondary endpoints include rates of virologic failure, as well as comprehensive safety and tolerability assessments across multiple dosing cohorts.

"The data we presented at CROI highlighted the strong safety profile and potent antiviral efficacy of TMB-365/380, receiving enthusiastic feedback from the global HIV research community," said Dr. Jimmy Chang, CEO of TaiMed Biologics. "This long-acting combination therapy not only eliminates the burden of daily oral regimens but also significantly reduces the risk of drug-drug interactions commonly seen with small molecules. Compared to other known long-acting options in development from global pharma companies, TMB-365/380 offers meaningful advantages in administration convenience, patient eligibility, and injection-site comfort."

Dr. Chang further emphasized the distinct advantages of the combination therapy, "Unlike other long-acting therapies currently in development, our regimen does not require resistance testing prior to initiation and still delivers robust levels of viral suppression. This positions TMB-365/380 as a potential game-changer—and future blockbuster—in the evolving landscape of HIV treatment. The Phase IIb study marks a critical milestone as we pursue global strategic partnerships and accelerate our path to commercialization. TaiMed remains dedicated to advancing a new generation of innovative, long-acting HIV therapies."