- ST Pharm has completed patient enrollment for the interim analysis of the ongoing Phase 2a clinical trial of STP0404 (Pirmitegravir), an investigational HIV treatment.
- The interim analysis of the Phase 2a study will evaluate the safety, pharmacokinetics, and antiviral activity in a minimum of 8 participants each for Cohort 1 (200 mg) and Cohort 2 (400 mg), totaling 16 participants.
- Safety will be assessed by evaluating adverse events, serious adverse events, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters at each dose level. Pharmacokinetics will involve calculating the mean (or geometric mean) pharmacokinetic parameters for each dose group.
- Antiviral activity will be measured by evaluating the change in HIV-1 RNA copies in plasma from baseline to Day 11 following once-daily oral administration for 10 consecutive days after breakfast at each dose level.
- In accordance with the clinical trial protocol, a Safety Review Committee (SRC) meeting will be held in June to discuss the safety, pharmacokinetics, and antiviral activity results of Cohorts 1 and 2, and to determine whether to proceed to Cohort 3 (600 mg).