- twoPhase 1 study shows that BRII-732 and BRII-778 are safe and well tolerated
- The results show promise for a long-acting combination therapy administered orally once weeklyHIV infection and supporting ongoing clinical development
- Authorized partners areData presented at IDWeek 2022 showcases the breadth of the company’s infectious disease program, covering 6 drug candidates and 4kindPossible signs
Beijing, China and Durham, NC, USAOctober 19, 2022 /PR Newswire/ — Tengsheng Boyao biotechnology Co., Ltd.(hereinafter referred to as “Tengsheng Biopharmaceuticals” or “Company”, stock code: 2137.HK), an international company dedicated to developing innovative treatments for unmet patient needs and major public health diseases, today announced two latest data from a Phase 1 study in healthy US volunteers evaluating the long-acting BRII-732 and BRII-778, two investigational drug candidates designed to treat human immunodeficiency virus (HIV) infection. Results from both studies show that once-weekly dosing of BRII-732 and BRII-778 is safe and well-tolerated, first-in-class once-weekly oral HIV combination therapy in development Provided important data support . The results of both studies were presented in a poster session at IDWeek 2022.
One of the posters was titled “Safety, Tolerability and Pharmacokinetic Profile of Islatravir BRII-732 Medoxomil Carbonate Product in Healthy Adult Subjects“, highlights the acceptable safety and tolerability of oral BRII-732 following a single ascending dose (SAD) of 200 mg and a multiple ascending dose (MAD) of 25 mg, as well as the ability to achieve excellent linear pharmacokinetic therapeutic goals ( PK).) These data reinforce the therapeutic potential of BRII-732 as a combination antiretroviral regimen including once-weekly dosing.
“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 improve the management of this lifelong infection while enabling access to new treatment options that are more convenient to administer. findings suggest that BRII-732 and BRII-778 hold promise as a safe and well-tolerated new patient treatment option that can help alleviate Patients’ daily medication burden, and even improve the social stigma that many people who are living with HIV are currently facing it. forward to advance the clinical development of two compounds, BRII-732 and BRII-778, into the next phase of research in an effort to provide the first oral long-acting combination therapy to patients.”
Another poster shown at IDWeek was titled “Safety, Tolerability and Pharmacokinetics of Rilpivirine Modified-Release Oral Formulation BRII-778 in Healthy Adult Subjects“, have shown that single ascending dose (SAD) and multiple ascending dose (MAD) administration of BRII-778 formulations were generally safe and well tolerated, with a slower linear pharmacokinetic (PK) and oral pharmacokinetic profile. involved consistently, providing key insights into the ongoing clinical evaluation and development of BRII-778 as a potential once-weekly dosing regimen for HIV.
Additionally, 16 abstracts published at IDWeek 2022 by Tengsheng Biopharmaceutical’s 3 strategic development partners showcased the infectious disease projects jointly developed with Tengsheng Biopharmaceuticals. This combined presentation on IDWeek further strengthens Tengsheng Biopharma’s scientific progress in developing a combination of anti-infectives to address a range of infectious diseases that place significant public health burdens on people worldwide. Among them, Tengsheng Biopharma has jointly promoted multidrug-resistant (MDR) and extensively drug-resistant (XDR) gram-negative bacterial infection treatment candidates with Qpex Biopharma in Greater China, and promoted jointly non-tuberculous mycobacteria treatment candidates with AN2 Therapeutics Licensing rights for drugs.
David Margolis, Ph.D., Head of Infectious Disease Therapeutics at Tengsheng Biopharmaceuticals, said: “This set of strong clinical data is from Tengsheng Biopharmaceuticals’ HIV program and our collaborative projects in multidrug resistance (MDR) and extensive drug resistance. antibiotic resistance (XDR) not only draws attention The company’s expertise and leadership in infectious diseases is a testament to our ongoing commitment to developing unique treatment options for patients and providers in areas of high medical need and growing medical need rapidly Working to bridge the gap between scientific advances and patient needs, and working to develop innovative treatment candidates for some of the world’s most common diseases, including HIV Current oral treatment options for HIV are limited to lifelong daily dosing, and many people infected with HIV believe that this method of administration is problematic and has seriously affected daily life.”
Registered attendees can view the posters presented at the conference online via the conference website.
forBRII-732/BRII-778 Combination Therapy
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 once weekly. This is a potentially better option for HIV patients currently on once-daily therapy. The combination therapy offers three different and comprehensive mechanisms of action – non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), nucleoside analogue reverse translocation inhibitor (NRTTI), potentially treating HIV-1 as complete regimen. BRII-732, a new chemical entity (NCE), is a proprietary product that is metabolized to the active moiety Islatravir after oral administration. Islatravir, an investigational drug candidate for the treatment and prevention of HIV infection, is a potent riboside reverse transcriptase inhibitor (NRTI) and a riboside analogue reverse transcriptase inhibitor (NRTTI). BRII-778 is an extended-release formulation of rilpivirine hydrochloride, an immediate-release non-nucleoside reverse transcriptase inhibitor (NNRTI) approved by the US Food and Drug Administration (FDA), effective against a range of a wide range of HIV-1 ■ strain isolates showing antiviral activity. BRII-778 is formulated as a modified-release oral tablet for once-weekly administration.
The company is working closely with the US FDA to modify its understanding of the CD4 + safety signal identified in studies involving islatravir and to address the current clinical trial suspension on for BRII-732, including resumption of BRII-732 dosing and once-weekly Oral development. BRII-732 and BRII-778 combination therapy.
About Tengsheng Boyao
Tengsheng Boyao Biotechnology Co, Ltd (“Tengsheng Boyao”; stock code: 2137.HK) is a biotechnology company based in China and the United States, dedicated to targeting major global infectious diseases (such as hepatitis B, COVID-19, Human immunodeficiency virus (HIV) infection, multidrug-resistant gram-negative bacterial infection (MDR) or extensively drug-resistant gram-negative bacterial infection) and other diseases of health burden significant public (eg, central nervous system (CNS) disease) development of innovative therapy. For more information, visit www.briibio.com.
