Tengsheng Bo Yao announced positive clinical data at IDWeek 2022 to support the continued development of current novel HIV treatment candidates

Tengsheng Boyao Biotechnology Co.
, Ltd.
(hereinafter referred to as "Tengsheng Boyao" or the "Company", stock code: 2137.
HK), a multinational company dedicated to developing innovative therapies for unmet patient needs and major public health diseases, on October 19 announced data from two Phase 1 studies evaluating long-acting BRII-732 and BRII-778 in healthy U.
S.
volunteers, two candidate candidates for the treatment of human immunodeficiency virus (HIV) infection
。 Both studies suggest that BRII-732 and BRII-778 are safe and well tolerated when administered weekly, providing important data support
for potential first-in-class oral once-weekly HIV combination therapies under development.
The results of these two studies were presented
in the poster session of IDWeek 2022.

One of the posters, "Safety, tolerability and pharmacokinetic profile of Islatravir's Medoxomil Carbonate prodrug BRII-732 in healthy adult subjects," highlighted the demonstrated acceptable safety and tolerability of oral BRII-732 after reaching 200 mg in a single ascending dose (SAD) and 25 mg in multiple ascending doses (MAD), and excellent linear pharmacokinetic (PK) characteristics
to achieve therapeutic goals.
These data reinforce the therapeutic potential
of BRII-732 as a combination antiretroviral regimen that includes once-weekly dosing.

Dr.
Ma Ji, Vice President of Preclinical Development and Clinical Pharmacology, said: "Our HIV research program aims to help improve the standard of care for the more than 38 million people living with HIV worldwide, many of whom want to better manage this lifelong infection while having access to new treatment options
that are more convenient for administration.
These findings suggest that BRII-732 and BRII-778 are expected to be a new and well-tolerated treatment regimen for patients that will help reduce the daily medication burden of patients and even improve the social discrimination currently faced by many people living with HIV
.
We look forward to advancing the clinical development of BRII-732 and BRII-778 compounds to the next phase of research in an effort to provide patients with the first oral long-acting combination regimen
.
" "

Another poster presented at IDWeek, "Safety, tolerability and pharmacokinetic profile of BRII-778 of Rilpivirine release oral formulation in healthy adult subjects", demonstrates that single incremental dose (SAD) and multiple incremental dose (MAD) administration of BRII-778 formulations is generally safe and well tolerated, and linear pharmacokinetic (PK) characteristics consistent with slower oral absorption, Provides key insights
into the ongoing clinical evaluation and development of BRII-778 as a potential once-weekly HIV treatment regimen.

In addition, 16 abstracts published by 3 strategic development partners of Tengsheng Bo Yao at IDWeek 2022 showcasing infectious disease projects
jointly developed with Tengsheng Bo Yao.
This collective presentation at IDWeek further strengthens the scientific progress of Tengsheng Bo Yao in developing anti-infective drug combinations to address a series of infectious diseases
that pose a significant public health burden to people around the world.
Among them, Tengsheng Biopharma has the license to
jointly advance multi-drug resistance (MDR) and extensively drug-resistant (XDR) gram-negative infection treatment candidates with Qpex Biopharma in Greater China, and non-tuberculous mycobacterial treatment candidates with AN2 Therapeutics.

Dr.
David Margolis, Head of Infectious Disease Therapeutics, said: "This set of strong clinical data from the HIV program and our collaborative projects in the areas of multidrug resistance (MDR) and extensively resistant (XDR) antibiotics not only highlights the company's expertise and leadership in infectious diseases, but also demonstrates our commitment to developing unique treatment options for patients and healthcare providers in areas where there is a huge and rapidly growing medical need
。 We have been working to bridge the gap between scientific breakthroughs and patient needs, and are committed to proposing innovative treatment
candidates for some of the world's most common diseases, including HIV.
Current oral regimens for HIV are limited to lifelong daily dosing, which many people living with HIV consider problematic and have serious implications for daily life
.
"

Posters displayed online for registered attendees can access the posters displayed online through the conference website
.

About BRII-732/BRII-778 combination therapy

The BRII-732/BRII-778 combination therapy is currently in Phase 1 development in the United States for the treatment of human immunodeficiency virus (HIV) infection and can be administered weekly
.
This is a potentially preferred option
for HIV patients currently receiving once-daily therapy.
This combination therapy offers three distinct and comprehensive mechanisms of action – non-nucleoside reverse transcriptase inhibitors (NNRTI), nucleoside reverse transcriptase inhibitors (NRTI), and nucleoside analogue reverse transcriptase translocation inhibitors (NRTTI) – with the potential to treat
HIV-1 as a complete treatment regimen.
BRII-732, a new chemical entity (NCE), is a proprietary prodrug that is metabolized to the active fraction of Islatravir
upon oral administration.
Islatravir, an investigational-stage drug candidate for the treatment and prevention of HIV infection, is both a potent nucleoside reverse transcriptase inhibitor (NRTI) and a nucleoside analogue reverse transcriptase translocation inhibitor (NRTTI).

BRII-778, an extended-release formulation of rilpivirine hydrochloride, is an immediate-release non-nucleoside reverse transcriptase inhibitor (NNRTI) approved by the U.
S.
Food and Drug Administration (FDA) that exhibits antiviral activity
against a wide range of HIV-1 isolates.
BRII-778 is a modulated oral tablet given
once weekly.

The Company is working closely with the U.
S.
FDA to adjust its understanding of CD4+ safety signals identified in Islatravir-related studies and address the current suspension of clinical trials for BRII-732, including reinstating BRII-732 dosing and developing weekly BRII-732 and BRII-778 oral combination therapies
.