ST Pharm said that France's drug regulatory agency, ANSM, has approved the company's plans to conduct the phase 1 clinical trial of STP0404, an acquired immune deficiency syndrome (AIDS) treatment candidate.
The Korean company plans to conduct single ascending doses, multiple ascending doses, and food effects of the treatment in 74 people in France, and confirm the results of the trial in the first half of next year. STP0404 is a first-in-class new drug that does not participate in the active site of HIV-1 integrase and inhibits the non-catalytically active site.
In preclinical studies, ST Pharm confirmed that STP0404 essentially blocks the proliferation and reactivation of the virus by pulling HIV's genetic material out of the capsid surrounding the viral gene.
The company expects that the treatment will be the first drug to cure AIDS in the world, as the human immune system can destroy suppressed HIV.
It has confirmed excellent inhibitory effects in both various cell lines infected with HIV and cell lines resistant to existing AIDS treatments. In repeated dose toxicity test and organizational pathology test, it also showed safety and drug metabolism stability, raising the expectations of the oral administration once a day.
The company plans to develop STP0404 as a long-acting injection in consideration of patient convenience, as long-lasting injections have the advantage of being able to improve the medication compliance problems fundamentally.
"STP0404 was found to be capable of completely treating AIDS in preclinical studies," a company official said. "We will do our best to develop STP0404 and protect the lives of AIDS patients."
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