Frontier Biotechnologies' First Long-acting Injectable (Aikening(R)), in a Two Drug Regimen for HIV, Proves Safe and Efficacious for Patients

The TALENT study (TALENT) findings,which were presented at the 11th International AIDS Society (IAS) Conference on HIV Science,showed that a two-drug regimen was as effective and safe as multi-drug therapies

TALENT is the world's first phase III clinical trial of the new long-acting HIV-1 fusion inhibitor,Aikening® (generic name: Albuvirtide [ABT]) in an all-Asian population

TALENT investigated the novel long-acting injectable combination dual therapy to treat people living with HIV (PLHIV) whohave failed initial treatment

ABT,a new fusion inhibitor given once weekly,is the first and only long-acting injectable available as a two-drug regimen for treatment-experienced patients with HIV-1 replication

BERLIN,July 19,2021 --In conjunction with the IAS Conference on HIV Science,Frontier Biotechnologies today announced positive top-line results for its phase 3 TALENT study,which demonstrated that an ABT-based two-drug treatment arm was non-inferior to a lopinavir (LPV)-based three-drug arm (75.7% vs 77.3%).

The results of the randomized controlled,open-labelled,multicenter,non-inferiority study showed successful achievement of the primary endpoint,with a good proportion of patients on the ABT regimen with HIV RNA less than 50 copies/mL at 48 weeks. The drug demonstrated efficacy against major strains of HIV,including resistant strains.

Additionally,the subjects who experienced virological failure at 48 weeks did not present with treatment emergent resistant associated mutations with gp41. The high genetic barrier to resistance of ABT+LPV/r meant no further resistance developed against these agents,which is important to avoid compromising future drug options for these treatment-experienced HIV patients.

Dr Dong Xie,Chief Scientific Officer,Chairman,Frontier Biotechnologiessaid,"IAS is the world's most influential meeting on HIV science. It leads the collective response on every front of the global HIV community. Frontier Biotechnologiesis delighted to break the TALENT study results,through the investigators,at this prestigious meeting. ABT+LPV/r (Albuvirtide plus boosted Lopinavir combination) is a preferred two-drug regimen as ABT is active against most HIV strains,including resistant strains,and has a high resistance barrier,while LPV/r is widely available in China. This is a robust example of a combination of two classes of drugs with different mechanisms of action providing a combination of complementary efficacies. Two NRTIs were replaced with Aikening® as the core,and rapid and persistent viral suppression was achieved in patients who failed initial treatment."

The phase 3 trial randomized 418 patients; more than 25% of patients were female and more than 70% patients had resistance to at least two drug classes. Further,approximately 25% of patients had CD4 cell count of less than 100,indicating advanced HIV disease with highly compromised immunity,who were at high risk of opportunistic diseases and death. In other words,this was a patient population that was relatively difficult to treat.

Dr. CJ Wang,CEO,"Today's announcement marks an important milestone in our efforts to create a long-acting injectable for treatment-experienced PLHIV (Patients Living with HIV) and critically ill,hospitalized AIDS patients who have limited choices for antiretroviral treatment. ABT is the first novel HIV long-acting ART discovered in China and we look forward to working closely with global regulators and HIV medical communities to bring ABT to more PLHIV in need,as quickly as possible."

The percentage of HIV RNA <400 copies/mL subjects treated at 48 weeks was 88.1% and 85.4%,respectively,and the viral load decreased by an average of 2.2 and 2.1 log10 copies/mL (p>0.05),CD4 increased by an average of 139.1 and 142.3 cells/µL (p>0.05). The results showed that with a two-drug regimen of ABT (replacing two NRTIs),patients could receive rapid and durable viral suppression for 48 weeks that is not inferior to standard second-line three-drug combination therapy.

Prof. Datuk Adeeba Kamarulzaman,President of IAS,said,"HIV is no longer a life-threatening disease. Newer antiretroviral treatments are always welcomed,especially those with better tolerability,fewer drug-drug interactions,and in long-acting injectable formulations with less frequent dosage administration. Now more than ever,we have more drug options to meet individual patient needs. ABT is one of these new options that possesses unique features to advance existing ART options."

The principal investigator of TALENT study,the physician of Infection Division in You 'An Hospital affiliated to Capital Medical University,Professor Wu Haosaid,"ABT once weekly was well tolerated in TALENTand there were no injection site reactions. The data also reinforced the advantages of ABT such as,good clinical adherence (>97%) of long-acting weekly injections was also demonstrated together with good overall safety.

The two-drug regimen with different targets is the future trend of ART research. It is worthy and we are looking forward to continuing to develop new HIV combinations of high efficacy and good tolerability for our patients."

About Aikening®

Aikening® is Frontier Biotechnologies' original new pharmaceutical product with independent intellectual property rights in the world's major markets.

In May 2018,Aikening® received a new drug certificate from the State Drug Administration in China. In October 2018,Aikening® was included as one of the major antiretroviral drugs available in the Chinese guidelines for diagnosis and treatment of HIV/AIDS (2018) issued by the Chinese Medical Association's Infectious Diseases Unit and the China Center for Disease Control and Prevention. In December 2020,Aikening® was enlisted as an exclusive patented product in the National List of Essential Medical Insurance,Industrial Injury Insurance and Maternity Insurance Drugs (2020).

Aikening® in combination with other antiretroviral treatment is effective for both major and drug-resistant viral strains. In a real world setting,Aikening® was widely accepted as one of the ARTs for patients with high unmet needs such as HIV hospitalization and critically-ill patients,liver and kidney dysfunctional patients and multiple drug-resistant patients due to the new mode of administration (once-weekly injection),lower pill burden,fast onset of action,high resistance barrier and well tolerated safety profile.

About Frontier Biotechnologies

Founded in 2013,Frontier Biotechnologies Inc. ("Frontier Biotech") is a commercial-stage biopharmaceutical company headquartered in China with global vision and world-class competitiveness. Frontier Biotech is committed to discovering,development,manufacturing,and commercialization of innovative medicines that improve patient health.

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