[Asia Economy Reporter Chunhee Lee] ST Pharm announced on the 3rd that it presented detailed results of the Phase 1 clinical trial of the acquired immunodeficiency syndrome (AIDS) treatment 'STP0404' at the 'AIDS 2022 - 24th International AIDS Conference' held in Montreal, Canada from the 29th of last month to the 2nd of this month.
The International AIDS Conference, now in its 24th year, is the world's largest AIDS conference organized by the International AIDS Society (IAS), which has about 170 member countries worldwide. Only 300 research results that have undergone rigorous review are registered as abstracts.
At this conference, ST Pharm presented a poster titled "The First-in-Human Clinical Trial of STP0404, a Novel Potent HIV-1 Allosteric Integrase Inhibitor." Allosteric refers to having a significant effect on enzymes and proteins without involving the active site of the enzyme or protein.
STP0404 is the world's first AIDS treatment undergoing human clinical trials with the integrase enzyme inhibitor (ALLINI) mechanism. Competing drugs developed with the same mechanism have all failed in preclinical stages due to toxicity issues.
The Phase 1 clinical trial results, conducted on 65 healthy males aged 18 to 45, showed that among a total of 28 adverse events (AEs), treatment-emergent adverse events (TEAEs) after administration were mostly mild to moderate, such as headache and diarrhea. No severe adverse events (Severe AE) or serious adverse events (SAE) were reported.
Additionally, no clinically significant side effects were observed in clinical laboratory tests, physical examinations, vital signs, and electrocardiogram evaluations. Even at the highest clinical trial doses?single ascending dose (SAD) of 800 mg and multiple ascending dose (MAD) of 400 mg?no clinically meaningful side effects appeared, so the maximum tolerated dose (MTD) was not determined.
The pharmacokinetic profile was consistent as well. Drug exposure increased proportionally with the administered dose, and sufficient drug exposure was achieved with once-daily oral administration. Accumulation in the body following the multiple ascending dose study was mild, and increased drug exposure was confirmed when taken after meals.
An ST Pharm official stated, "In preclinical trials, when STP0404 was administered at 0.01 to 10 micromolar to immune T cells where AIDS virus reactivation occurred, P24 (a protein produced during viral infection and an indicator of viral infection) exceeding 270 pg/mL was reduced to 30 pg/mL, effectively confirming a cure. STP0404 demonstrated excellent antiviral effects even as a monotherapy and showed outstanding efficacy against patient-derived AIDS viruses with resistance and reactivated AIDS viruses, confirming its potential as a curative treatment."
He added, "With safety proven through this Phase 1 clinical trial, we expect momentum to accelerate for the Phase 2a trial. We have completed the pre-IND (preclinical trial plan) with the U.S. Food and Drug Administration (FDA) and plan to promptly submit the IND application to enter Phase 2a within this year."
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