ST Pharm’s Primitegravir offers potential breakthrough in HIV treatment

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ST Pharm’s Primitegravir offers potential breakthrough in HIV treatment

Published: 29 Oct. 2025, 18:00

The office of ST Pharm, which presented on a potential breakthrough in HIV treatment with its Primitegravir drug at IDWeek 2025 [DONGA ST]

ST Pharm recently presented on Primitegravir, a drug that may offer new possibilities for HIV treatment.

The bio-manufacturer gave the presentation at IDWeek 2025, which was held in Atlanta from Oct. 19 to 22, drawing more than 10,000 participants each year. Jointly organized by leading organizations such as the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America and the HIV Medicine Association, the prestigious conference on infectious diseases is attended by infectious disease specialists, scientists, epidemiologists, and biotechnology companies.

ST Pharm presented the interim results of its Phase 2a clinical trial for STP0404, known as Primitegravir, which was conducted among adults aged 18 to 65 who were infected with HIV-1 but had not received prior treatment, evaluating the antiviral activity, safety, tolerability and pharmacokinetic (PK) characteristics of the drug.

According to the interim analysis, plasma HIV01 RNA levels in the treatment group showed a significant reduction by the 11th day, with an average decrease of 1.191 – 1.552 log10 copies, exceeding the U.S. FDA’s primary efficacy threshold of 0.5 log10 for HIV-1 infection treatments.

The safety profile was also favorable. Among 16 adverse events reported, three were considered possibly related to the study drug. However, no serious or significant adverse outcomes, nor any treatment discontinuations, were observed in the interim analysis.

The (PK) profile of Primitegravir increased in a dose-dependent manner, with peak plasma concentration reached approximately four-and-a-half to five-and-a-half hours after administration. The mean half-life ranged from 11.6 to 13.7 hours, and no meaningful drug accumulation was observed after 10 days of repeated dosing.

Primitegravir is an allosteric HIV-1 integrase inhibitor (ALLINI) that disrupts the viral replication cycle through an indirect mechanism. It is the only ALLINI candidate currently undergoing human clinical trials, positioning it as a first-in-class new drug.

Since its early development stage, Primitegravir has drawn attention in the pharmaceutical industry as one of the “HIV clinical trials to watch in 2024” by medical trial publication platform Clinical Trials Arena, reflecting high global expectations.

ST Pharm is currently enrolling and dosing participants for Cohort 3 at 600 milligram doses, with the goal of receiving the final clinical study report in the first half of 2026.

BY JANG HAYOON [[email protected]]

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