Jiangsu Aidea Pharmaceutical Co., Ltd. (hereinafter referred to as “Aidea Pharma”) will present the findings from two clinical studies on the innovative drug Ainuovirine (ANV) Tablets and its single-tablet regimen (STR) Ainuomiti Tablets (ANV/3TC/TDF) at the25^th International AIDS Conference (AIDS 2024). Hosted by the International AIDS Society (IAS), an organization that is among the world's leading centers for HIV/AIDS research, 

AIDS 2024 will be held in Munich, Germany, from July 22 to 26, 2024. An estimated 15,000 scientists, clinical experts and other professionals engaged in HIV health from around the world will attend AIDS 2024.

Ainuovirine Tablets, approved for marketing in June 2021, is the first domestically developed oral anti-HIV/AIDS new drug in China. As a new generation of non-nucleoside reverse transcriptase inhibitors (NNRTIs), Ainuovirine Tablets has excellent pharmacological characteristics such as strong antiviral activity, less cross-resistance, high target selectivity, and fewer drug-drug interactions.

Ainuomiti Tablets, a combination of Ainuovirine with Lamivudine and Tenofovir Disoproxil Fumarate, is the first independently developed anti-HIV/AIDS innovative STR in China.

A population pharmacokinetic study on Ainuovirine Tablets and a phase III clinical trial on Ainuomiti Tablets (SPRINT study) will be presented at the conference.

Study 1: Population pharmacokinetics of ainuovirine and exposure-response analysis in people living with HIV ^[1]

Presenting Author: Prof. Bin Su (Beijing Youan Hospital, Capital Medical University)

Presenting Date: Tuesday, July 23, 2024, 12:00-13:00 PM

Presenting Venue: Messe München, Messegelände, Munich, Germany

This study collected plasma concentration-time data from phase I and phase III clinical trials of ANV to develop the population pharmacokinetic (PopPK) model, analyzing the correlation between drug exposure and efficacy/safety. It showed that ANV exhibited a nonlinear pharmacokinetic profile, which was best described by a two-compartment model with first-order elimination. It was supported ANV 150 mg once daily as the recommended dose for people living with HIV (PLWH), requiring no dose adjustment for the studied factors including age, gender, liver function and others.

Study 2: Noninferior efficacy, reduced weight gain, and improved lipid metabolism of switch to ainuovirine- versus boosted elvitegravir-based regimen in virologically suppressed people living with HIV-1: 48-week results of the SPRINT trial ^[2]

Presenting Author: Prof. Fujie Zhang (Beijing Ditan Hospital, Capital Medical University)

Presenting Date: Thursday, July 25, 2024, 12:00-13:00 PM

Presenting Venue: Messe München, Messegelände, Munich, Germany

The SPRINT study is a multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferior study to evaluate the efficacy and safety of Ainuomiti Tablets compared to Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets (EVG/Cobi/FTC/TAF) in virologically suppressed PLWH. A total of 762 treatment-experienced PLWH were randomly assigned (1:1) to receive ANV/3TC/TDF or EVG/Cobi/FTC/TAF for up to 48 successive weeks, followed by an optional open-label extension period with 48-week ANV/3TC/TDF treatment. The 48-week study data will be presented at this conference. This study showed that in virologically suppressed PLWH, switch to ANV/3TC/TDF can maintain virological suppression non-inferior to EVG/Cobi/FTC/TAF, and has additional benefits in terms of cardiovascular metabolic safety, such as blood lipid metabolism.

The presentation of these two clinical research findings on Ainuovirine Tablets and its STR Ainuomiti Tablets at AIDS 2024, is another milestone in Aidea Pharma’s ongoing expansion into international markets. It also represents the international anti-HIV academic community’s full recognition of Aidea Pharma's clinical research achievements on anti-HIV new drugs. Aidea Pharma has been dedicated to the R&D of anti-HIV new drugs, enhancing its international influence, and leading future trend of R&D on anti-HIV new drug, to benefit the global PLWH.

Reference

[1] Bin Su, Xiaoxu Han, Jin Sun et al. Population pharmacokinetics of ainuovirine and exposure-response analysis in people living with HIV [C]. The 25^th International AIDS Conference, 2024.

[2] Zhang F, Wu H, Ma P, et al. Noninferior efficacy, reduced weight gain, and improved lipid metabolism of switch to ainuovirine- versus boosted elvitegravir-based regimen in virologically suppressed people living with HIV-1: 48-week results of the SPRINT trial [C]. The 25^th International AIDS Conference, 2024.

Disclaimer

The above content is compiled from publicly published papers and does not represent the views or positions of Aidea Pharma. It is intended only for the purpose of medical professionals learning and communication, and is not intended for commercial promotion or as a treatment advice. If you need treatment, please contact a professional