ST Pharm Presents Phase 1 Clinical Trial Results of HIV Treatment Candidate at AIDS 2022

–   STP0404 is the only clinical safety proven HIV treatment candidate with a novel mechanism that can block HIV re-activation.

–   STP0404 is expected to enter Phase 2a clinical trial in the US in 4Q 2022.

SEOUL, South Korea, Aug. 3, 2022 /PRNewswire/ — ST Pharm Co., Ltd. (237690:KOSDAQ) announced on 3rd August that the Phase 1 clinical trial results of STP0404, the HIV treatment candidate, was presented at the 24th International AIDS Conference took place in Montreal, Canada from 29th July to 2nd August.

The International AIDS Conference is the biggest AIDS conference worldwide, held by the International AIDS Society (IAS) which has over 13,000 members from more than 170 countries. All submitted abstracts went through a blind peer-review process by international reviewers and only 300 abstracts were selected to be presented. Among those, the Phase 1 clinical trial results of STP0404 was selected with high score and was formally invited for poster presentation with a poster title, “The First-in-Human Clinical Trial of STP0404, a Novel Potent HIV-1 Allosteric Integrase Inhibitor”.

STP0404 is the world’s first AIDS treatment with an ALLINI (Allosteric Integrase Inhibitor) mechanism in human clinical trials. All competing drugs developed with the same mechanism failed in preclinical stage due to toxicity issues.

A total of 65 healthy male adult participants, aged from 18 to 45, were included in this Phase 1 clinical study. A total of 28 adverse events (AE) were reported. Headache and diarrhoea with mild to moderate intensity were most frequently reported as treatment emergent adverse events (TEAE). There were no severe AE, Serious AE reported and no clinically significant trend or abnormalities observed in laboratory tests, physical examination, vital signs and ECG evaluations. Since there were no clinically significant AEs reported at the highest dose levels (800 mg in single ascending dose part [SAD] and 400 mg in multiple ascending dose part [MAD]), the maximum tolerated dose was not confirmed. STP0404 also demonstrated consistent pharmacokinetics at various dose levels showing drug exposure increased less-proportionally with dose, and presented an elimination half-life can support once daily dosing regimen.

ST Pharm stated, “From nonclinical studies, dosing with 0.01~10 μM of STP0404 in HIV reactivated T cells reduced the p24 level from over 270 pg/mL to 30 pg/mL. These results can be considered as potentially functional cure. STP0404 not only has optimal antiviral effects as mono-treatment against wild-type strains, but also presented excellent antiviral activities against clinical isolates and reactivated virus that have developed resistance. As the safety of STP0404 was confirmed in Phase 1 trial, a Phase 2a study is planned to be initiated this year.”

ST Pharm is further evaluating the clinical potential of co-administering STP0404 with marketed AIDS treatments, and is also developing long-acting injectables.

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