Phase III trial of weekly drug albuvirtide meets endpoints in treating patients with HIV/AIDS- Frontier Biotechnologies

Frontier Biotechnologies Inc. reported that a phase III clinical trial (TALENT Study) of its lead product albuvirtide met the primary objective based on an interim analysis in HIV/AIDS infected patients. The results demonstrated that once-weekly given albuvirtide plus ritonavir-boosted lopinavir was non-inferior to WHO-recommended second-line three-drug regimen (control) at 48-week in treatment experienced HIV-1 infected adults. In addition, patients administered with albuvirtide showed statistically better renal safety than those taking the control regimen containing tenofovir disoproxil fumarate.

Conducted at 12 sites in China, the TALENT study is a randomized, controlled, open-label phase 3 clinical trial. Patients who failed WHO-recommended first-line treatment were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly by intravenous injection) plus ritonavir-boosted lopinavir or two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and ritonavir-boosted lopinavir. For the modified intention-to-treat population, 24-week data were available for 83 and 92 patients, and 48-week for 46 and 50 patients in the albuvirtide and control groups respectively. At 48-week, 80.4% patients in albuvirtide group had HIV-1 RNA less than 50 copies per mL, the primary end point, versus 66.0% in control group (difference 14.4%). The non-inferiority criterion was met.

Consistent with the result, key secondary end points, including proportion of patients with HIV-1 RNA less than 50 copies per mL at 24-week and less than 400 copies per mL at 48-week, change from baseline in viral load and CD4+ cell count at 48-week, were also met. Both regimens were generally well tolerated, patient adherence, adverse events and laboratory abnormalities were similar. Patients taking albuvirtide and ritonavir-boosted lopinavir showed significantly smaller increase in mean serum creatinine at 12 and 24-week than those taking the control drugs containing tenofovir disoproxil fumarate.

Comment: All IV drugs approved for HIV treatment in the U.S. require at least once-a-day dosing. The only other once-a-week drug is an injectable, enfuvirtide. Both enfuvirtide and albuvirtide are cell fusion inhibitors and prevent HIV from fusing with healthy cells and infecting them.