NEW TROGARZO DATA PRESENTED AT CROI DEMONSTRATES SUSTAINED VIRAL SUPPRESSION AT WEEK 96
TaiMed is pleased to announce that new data, presented today at the 26th annual Conference on Retroviruses and Opportunistic Infections (CROI), show that Trogarzo® (ibalizumab-uiyk) injection maintains viral suppression at week 96.
Patients rolled over into the TMB-311 trial had, at baseline, a median viral load of 21,700 copies/mL. 19% of patients had a viral load ≥100,000 copies/mL. The median CD4+ cell count was 102 cells/µL.
At both week 25 and week 96, 15 of 27 patients (56%) achieved viral suppression (<50 copies/mL). At week 96, the median viral load reduction was 2.8 log10 compared to 2.5 log10 at week 25. The median CD4+ cell count increase was 45 cells/µL at week 96 in comparison to 42 cells/µL at week 25.
In addition, Trogarzo®, combined to an optimized background regimen (OBR), was still well tolerated at week 96 with no safety concerns emerging.
TMB-311 is a continuation of the pivotal of the 24-week, single-arm TMB-301 trial. The eligible 27 patients who completed TMB-301 rolled over into the TMB-311 trial to assess safety and efficacy of the treatment over a longer period of time.
Overall, the efficacy results observed at week 25 were maintained until week 96.
Efficacy in dolutegravir (DTG) and darunavir (DRV) patients in TMB-301
Trogarzo® was also shown to be effective in patients with dolutegravir (DTG) or darunavir (DRV) as part of their OBR. DTG and DRV are two commonly used antiretrovirals.
At week 25, 44% of patients resistant to DTG, achieved a viral load reduction >0.5 log10 from baseline while 82% of DTG susceptible patients reached the same reduction level.
“The increased efficacy of Trogarzo® in patients susceptible to DTG compared to DTG resistant patients is an interesting finding as it supports an earlier intervention with Trogarzo® in patients showing early signs of multidrug resistance,” said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies Inc.
In DRV resistant patients, 67% of patients achieved a viral load reduction >0.5 log10 from baseline while 62% of DRV susceptible patients reached the same reduction level.