Frontier Biotechnologies has reported that a phase-3 clinical trial (TALENT Study) of its lead product albuvirtide meets primary objective based on an interim analysis.
The results demonstrated that once-weekly given albuvirtide plus ritonavir-boosted lopinavir was non-inferior to World Health Organisation-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.
“TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. The interim results showed that combining the once-weekly given albuvirtide with an orally taken protease inhibitor is safe, effective, and practical,” said Dr Dong Xie, chair and chief scientific officer of Frontier Biotech. “We believe that albuvirtide, with its novel mechanism of action and long half-life that supports once weekly or biweekly dosing, has the potential to help address intolerability to oral drugs, drug resistance, and poor medication adherence.”
Conducted at 12 sites in China, the TALENT study is a randomised, 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%, 95% CI -3.0 to 31.9). The non-inferiority criterion is 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.
Frontier will be seeking for accelerated approval from China Food and Drug Administration.