TaiMed Biologics have released additional preliminary results of the Phase 3 trial of ibalizumab in 40 patients with multi-drug resistant (MDR) HIV-1 (TMB-301).
Ibalizumab is a humanized monoclonal antibody. TaiMed previously announced that 83% of patients enrolled in the TMB-301 (33/40, P<0.0001) met the primary endpoint of a decrease of ≥0.5 log10 in viral load following a 7-day treatment period with ibalizumab.
The latest results show that at the end of the 24-week, single arm study, 43% (17/40) using ibalizumab with optimized background regimen (OBR) had an undetectable viral load (HIV-1 <50 copies/mL). Representing a mean viral load reduction of 3.1 log10.
The mean viral load at baseline was 100,287 copies/mL, and 53% of patients reached a viral load lower than 400 copies/mL at trial completion. One serious adverse event of immune reconstitution inflammatory syndrome occurred; an inflammatory response in HIV-infected patients which may be triggered after changing to more active antiretroviral therapy (ART). Most adverse events were reported mild to moderate in severity.
Nine patients discontinued the trial prior to completion; 4 due to non-drug related deaths, 3 withdrew, and 2 were lost to follow-up.
“If approved by the FDA, ibalizumab would be the first long-acting and the first biologic product to show such efficacy in patients with highly resistant HIV-1,” said Dr. Jacob Lalezari, medical director of Quest Clinical Research, a division of eStudySite.
TaiMed is a partner of Theratechnologies, and the results of this trial will now support the submission of the Biologics License Application (BLA) to the Food and Drug Administration (FDA). Previously, ibalizumab had been given ‘orphan drug’ status and designated ‘breakthrough therapy’ by the FDA.
For more information visit Theratech.com.