China-based Brii Biosciences Limited (HKG: 2137) has published the latest results of two Phase I clinical studies assessing its long-acting BRII-732 and BRII-778, both being developed to treat HIV infection, in healthy subjects in the US. The results showed that both BRII-732 and BRII-778 produced good safety and tolerability profiles when administered once per week.
Study Results for BRII-732
One study, titled “Safety, tolerability, and pharmacokinetics of the prodrug BRII-732 of Islatravir’s Medoxomil Carbonate in healthy adult subjects,” showed that oral BRII-732 produced acceptable safety and tolerance after a single ascending dose (SAD) of 200 mg and a multiple ascending dose (MAD) of 25 mg. The study also demonstrated excellent linear pharmacokinetics (PK) characteristics, suggesting that BRII-732 has therapeutic potential as a weekly administration combined with antiretroviral therapy.
Study Results for BRII-778
The second study, titled “Safety, tolerability and pharmacokinetics characteristics of Rilpivirine regulated release oral preparation BRII-778 in healthy adult subjects,” showed that the safety and tolerance of the BRII-778 preparation via SAD and MAD was good. The linear PK characteristics were consistent with slow oral absorption, suggesting that the BRII-778 preparation is expected to be a potential HIV treatment scheme with weekly administration.
Drug Profiles
BRII-732 is a proprietary prodrug of a new chemical entity (NCE) that can be metabolized into the active part of Islatravir after oral administration. Islatravir, an HIV drug candidate, is not only a nucleoside reverse transcriptase inhibitor (NRTI) but also a nucleoside reverse transcriptase transposition inhibitor (NRTTI).
BRII-778 is a rapid-release non-nucleoside reverse transcriptase inhibitor (NNRTI) approved by the US FDA. It is a sustained-release preparation of rilpivirine hydrochloride, showing antiviral activity against a wide range of HIV-1 isolates. The BRII-778 preparation is a transdermal oral tablet administered once a week.
Future Outlook
The BRII-732/BRII-778 combination, administered once a week, is currently undergoing a Phase I study in the US. These positive Phase I results highlight Brii Biosciences’ progress in developing long-acting HIV treatments, potentially offering a more convenient and effective therapy option for patients.-Fineline Info & Tech
