the United States and Canada, recently announced Week 96 data from the Phase 2b trial (NCT03272347) evaluating the efficacy and safety of islatravir, the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with doravirine (PIFELTRO™), in treatment-naïve adults with HIV-1 infection. Week 96 findings demonstrated that the combination of islatravir and doravirine maintained virologic suppression (as measured by the number of study participants achieving HIV-1 RNA levels <50 copies/mL, similar to DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate)), and the findings were consistent with Week 48 results. Additional Week 96 data from the study show low rates of participants meeting the definition of protocol-defined virologic failure (PDVF) in both the islatravir plus doravirine and the DELSTRIGO treatment arms, and no participants in either arm met the criteria for resistance testing. Merck also announced results from Phase 1/1b studies for MK-8507, the company’s investigational once-weekly oral non-nucleoside reverse transcriptase inhibitor (NNRTI), which showed that the antiviral potency and pharmacokinetics of MK-8507 support further investigation for once-weekly oral administration as part of combination antiretroviral therapy.
Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicines company, and Pfizer Inc. (NYSE: PFE) recently announced that the first participant has been dosed in the Phase 3 AFFINE study of giroctocogene fitelparvovec (SB-525), an investigational gene therapy for hemophilia A patients.
AFFINE is a global Phase 3, open-label, multicenter, single arm study that will evaluate the efficacy and safety of giroctocogene fitelparvovec in patients with moderately severe to severe hemophilia A. The primary endpoint is impact on annual bleed rate (ABR) through 12 months following treatment with giroctocogene fitelparvovec, compared to ABR on Factor VIII (FVIII) replacement therapy collected in the Phase 3 lead-in study period. Participants will be analyzed throughout the 5-year study period following the single infusion to further assess the durability and efficacy.
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