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On March 9, ViiV Healthcare, a subsidiary of GSK, announced that GSK3640254 had obtained positive data in the Phase IIa proof-of-concept study, showing a good drug dose-antiviral effect relationship.
GSK3640254 is an HIV-1 virus maturation inhibitor.
The Phase IIa study adopted an adaptive design and included two phases to evaluate the antiviral activity, safety, and tolerability of GSK3640254 once a day in 34 untreated adult HIV-1 infected patients.
The results showed that the maximum mean changes in viral load in the 140 mg and 200 mg groups at the end of the study were -1.
Kimberly Smith, head of ViiV Healthcare's R&D department, said: “It is very common for HIV-1 infected patients to fail anti-HIV treatment during their lifetime.
BMS also announced in July 2015 the positive data of a phase IIa proof-of-concept study of BMS-955176, a mature inhibitor jointly developed by it and ViiV Healthcare.
ViiV Healthcare has begun a Phase IIb study of GSK3640254 to evaluate the efficacy, safety and tolerability of this mature inhibitor as a combination therapy for newly-treated HIV-1 infected adult patients.