Frontier Biotech's Long-acting HIV-1 Fusion Inhibitor Albuvirtide Meets 48-Week Primary Objective: Interim Results of a Phase 3 Trial

PR64683

NANJING, China, June 6, 2016 /PRNewswire=KYODO JBN/ --

Frontier Biotechnologies Inc. today 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

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.

"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 Dong Xie, PhD, Chairman 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 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%,

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. Additional information about the study can be found at

www.clinicaltrials.gov.

About Frontier Biotechnologies Inc.

Frontier Biotech is a research-based pharmaceutical company dedicated to the

development and commercialization of next-generation therapeutic products

addressing significant unmet medical needs. Its lead product candidate

albuvirtide, a novel long-acting anti-HIV agent, is in Phase 3 trial in China

and an NDA is to be submitted to China FDA in 2016. Its second lead product

candidate AB001, a novel patch product for treatment of musculoskeletal pain

and inflammation, has recently completed a Phase 2 clinical trial in the US.