On the 24th, TaiMed Biologics announced that its long-acting combination therapy, TMB-365/TMB-380, administered every two months for HIV treatment, has reached the final patient visit (LPLV) in its Phase 2a clinical trial. Preliminary analysis of the trial results is expected by the end of this year or early next year, with relevant updates and international conference data presentations to follow. If the results meet expectations, TaiMed plans to advance to a Phase 2b trial in 2025 and continue discussions with major pharmaceutical companies for potential licensing partnerships.
TaiMed stated that TMB-365/TMB-380 is an innovative long-acting monoclonal antibody combination therapy, being developed as a comprehensive frontline maintenance treatment for HIV. This novel therapy aims to capture a significant share of the $10 billion annual market for long-acting first-line maintenance therapies.
The Phase 2a trial for TMB-365/TMB-380 enrolled 20 participants and employed an eight-week dosing regimen to evaluate the combination’s efficacy, safety, and pharmacokinetics. The trial targeted HIV patients whose viral loads were already suppressed following first- or second-line treatments. Participants transitioned from existing antiretroviral therapies to the long-acting TMB-365/TMB-380 combination.
During the trial, participants received injections every eight weeks for a total of three treatments. After completing the study, they resumed daily oral antiretroviral therapy and were monitored for an additional four weeks for follow-up testing and assessments.
TaiMed highlighted that TMB-365 is the second-generation drug derived from its groundbreaking HIV treatment, Trogarzo. As a post-attachment inhibitor, TMB-365 offers enhanced potency, broader viral coverage, and a longer half-life, resulting in lower drug dosages, reduced resistance, and extended efficacy. Meanwhile, TMB-380, a next-generation broadly neutralizing monoclonal antibody, delivers improved viral coverage and durability. Together, TMB-365 and TMB-380 are designed as a safe and effective non-oral long-acting maintenance therapy for patients with suppressed viral loads.
Preliminary data indicates that TMB-365 and TMB-380 effectively reduce viral loads and demonstrate strong antiviral activity. Their pharmacokinetic profiles suggest the potential for dosing every two or three months. TaiMed began the clinical development of this combination in 2022 with a Phase 1b/2a trial. In September 2023, the company completed the Phase 1b trial’s pioneer cohort and presented its findings at the 2024 CROI conference in March. The Phase 2a trial’s core cohort is currently ongoing.
Resource: 中裕長效型抗愛滋病新藥2a試驗 今年底可獲得結果分析
